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This approval is based on the Phase 3 ATTRACTION-3 trial, which evaluated Opdivo versus chemotherapy (docetaxel or paclitaxel) for the treatment of patients with unresectable advanced or recurrent esophageal squamous cell carcinoma (ESCC) refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs. For the primary endpoint of overall survival (OS), Opdivo demonstrated a 23% reduction in the risk of death (Hazard Ratio (HR) 0.77; 95% Confidence Interval (CI): 0.62 to 0.96; p=0.019) and a 2.5-month improvement in median OS (10.9 months (95% CI: 9.2 to 13.3)) compared with chemotherapy (8.4 months (95% CI: 7.2 to 9.9)). The safety profile of Opdivo in this trial was consistent with previously reported studies in solid tumors. The ATTRACTION-3 trial was sponsored by Ono Pharmaceutical Co. Ltd. of Japan, Bristol-Myers Squibb’s development partner for Opdivo.

“Alongside our partner, Ono Pharmaceutical, we are proud to offer Opdivo as an alternative to chemotherapy for patients in Japan with esophageal cancer, regardless of their PD-L1 status,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. “This first-ever approval of Opdivo in esophageal cancer exemplifies our commitment to advancing treatment options with the potential to extend survival for patients with difficult-to-treat gastrointestinal cancers.”

About ATTRACTION-3

ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) is a Phase 3, multi-center, randomized, open-label global study, evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for patients with esophageal cancer refractory or intolerant to first-line combination therapy with fluoropyrimidine and platinum-based drugs. Patient enrollment occurred predominantly in Asia, with the remainder in the United States and Europe. Patients were treated until disease progression or unacceptable toxicity. The primary endpoint of the trial was OS. Secondary endpoints include investigator-assessed objective response rate, progression-free survival, disease control rate, duration of response and safety.

Patients treated in the Opdivo arm showed 12- and 18-month OS rates of 47% (95% CI: 40 to 54) and 31% (95% CI: 24 to 37), respectively, versus 34% (95% CI: 28 to 41) and 21% (95% CI: 15 to 27) among patients in the chemotherapy arm. Survival benefit with Opdivo was observed regardless of tumor PD-L1 expression levels. An exploratory analysis of patient-reported outcomes showed significant overall improvement in quality of life with Opdivo versus chemotherapy.

Fewer treatment-related adverse events (TRAEs) were reported with Opdivo versus chemotherapy, with a rate of 66% of any grade TRAEs for patients receiving Opdivo compared to 95% for patients receiving chemotherapy. Patients in the Opdivo arm also experienced a lower incidence of Grade 3 or 4 TRAEs compared to those in the chemotherapy arm (18% versus 63%), and the percentage of patients experiencing TRAEs leading to discontinuation was the same in both arms (9%).

Data from the study were featured in a Presidential Symposium during the European Society for Medical Oncology 2019 Annual Congress and simultaneously published in The Lancet Oncology.

About Esophageal Cancer

Esophageal cancer is the seventh most common cancer and the sixth most common cause of death from cancer worldwide. The five-year relative survival rate is 8% or less for patients diagnosed with metastatic disease. Globally, an estimated 572,000 new cases of esophageal cancer are diagnosed each year, nearly 80% of which occur in Asia. In Japan, approximately 20,000 cases are diagnosed and 12,000 deaths are caused by esophageal cancer every year. The two most common types of esophageal cancer are adenocarcinoma and squamous cell carcinoma, the latter accounting for approximately 90% of all esophageal cancer cases diagnosed in Japan. The majority of cases are diagnosed in the advanced setting and impact a patient’s daily life, including their ability to eat and drink.

Bristol-Myers Squibb: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO®

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy, and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Neuropathies

In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin Adverse Reactions and Dermatitis

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic syndrome.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate study in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusions, and dehydration. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY and in 43% of patients receiving sunitinib. The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis; in patients treated with sunitinib, they were pneumonia, pleural effusion, and dyspnea. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients (n=154). The most frequent serious adverse reactions reported in ≥2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, and pneumonia. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 032, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=245) were fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%), and cough (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) vs sunitinib (n=535) were fatigue (58% vs 69%), rash (39% vs 25%), diarrhea (38% vs 58%), musculoskeletal pain (37% vs 40%), pruritus (33% vs 11%), nausea (30% vs 43%), cough (28% vs 25%), pyrexia (25% vs 17%), arthralgia (23% vs 16%), decreased appetite (21% vs 29%), dyspnea (20% vs 21%), and vomiting (20% vs 28%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent, the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Recommended Dose Modifications

Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue in patients with severe or life-threatening infusion reactions.

Endocrine: Withhold YERVOY for symptomatic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.

Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment.

All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions.

Immune-Mediated Enterocolitis

Immune-mediated enterocolitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms. Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent). Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients. Consider adding anti-TNF or other immunosuppressant agents for management of immune-mediated enterocolitis unresponsive to systemic corticosteroids within 3-5 days or recurring after symptom improvement, if other causes are excluded. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 YERVOY-treated patients (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 YERVOY-treated patients (5%). Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis. Infliximab was administered to 5 (8%) of the 62 patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-5 immune-mediated enterocolitis occurred in 76 patients (16%) and Grade 2 enterocolitis occurred in 68 patients (14%). Seven (1.5%) developed intestinal perforation and 3 patients (0.6%) died as a result of complications.

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

Immune-mediated hepatitis, including fatal cases, can occur with YERVOY. Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution. Withhold YERVOY in patients with Grade 2 hepatotoxicity. Permanently discontinue YERVOY in patients with Grade 3-4 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5× the ULN or total bilirubin elevations >3× the ULN; Grade 3-5) occurred in 8 YERVOY-treated patients (2%), with fatal hepatic failure in 0.2% and hospitalization in 0.4%. An additional 13 patients (2.5%) experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5× but ≤5× the ULN or total bilirubin elevation >1.5× but ≤3× the ULN; Grade 2). In a dose-finding trial, Grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent YERVOY (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID). In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated hepatitis occurred in 51 patients (11%) and moderate Grade 2 immune-mediated hepatitis occurred in 22 patients (5%). Liver biopsy performed in 6 patients with Grade 3-4 hepatitis showed evidence of toxic or autoimmune hepatitis.

Immune-Mediated Dermatitis

Immune-mediated dermatitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically; administer topical or systemic corticosteroids if there is no improvement within 1 week. Withhold YERVOY in patients with moderate to severe signs and symptoms. Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe, life-threatening, or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 YERVOY-treated patients (2.5%); 1 patient (0.2%) died as a result of toxic epidermal necrolysis and 1 additional patient required hospitalization for severe dermatitis. There were 63 patients (12%) with moderate (Grade 2) dermatitis. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated dermatitis occurred in 19 patients (4%). There were 99 patients (21%) with moderate Grade 2 dermatitis.

Immune-Mediated Neuropathies

Immune-mediated neuropathies, including fatal cases, can occur with YERVOY. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities). Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities), such as Guillain-Barré-like syndromes. Institute medical intervention as appropriate for management for severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. In patients receiving YERVOY 3 mg/kg in MDX010-20, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-5 immune-mediated neuropathy occurred in 8 patients (2%); the sole fatality was due to complications of Guillain-Barré syndrome. Moderate Grade 2 immune-mediated neuropathy occurred in 1 patient (0.2%).

Immune-Mediated Endocrinopathies

Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY. Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated. Monitor clinical chemistries, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY in symptomatic patients and consider referral to an endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 YERVOY-treated patients (1.8%). All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 patients (2.3%) and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 2.5 months and ranged up to 4.4 months after the initiation of YERVOY. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated endocrinopathies occurred in 39 patients (8%) and Grade 2 immune-mediated endocrinopathies occurred in 93 patients (20%). Of the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of the 39 patients were hospitalized for immune-mediated endocrinopathies. Of the 93 patients with Grade 2 immune-mediated endocrinopathy, 74 had primary hypopituitarism (associated with 1 or more secondary endocrinopathy, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 9 had primary hypothyroidism, 3 had hyperthyroidism, 3 had thyroiditis with hypo- or hyperthyroidism, 2 had hypogonadism, 1 had both hyperthyroidism and hypopituitarism, and 1 subject developed Graves’ ophthalmopathy. The median time to onset of Grade 2 immune-mediated endocrinopathy was 2.1 months (range: 9 days-19.3 months).

Other Immune-Mediated Adverse Reactions

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions. Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity. Immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss. Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss. Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive a CTLA-4 receptor blocking antibody either before or after allogeneic hematopoietic stem cell transplantation (HSCT). Follow patients closely for evidence of GVHD and intervene promptly. Consider the benefit versus risks of treatment with a CTLA-4 receptor blocking antibody after allogeneic HSCT. In MDX010-20, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients: cytopenias, nephritis, pneumonitis, meningitis, pericarditis, uveitis, and iritis. In CA184-029, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients unless specified: cytopenias, eosinophilia (2.1%), pancreatitis (1.3%), meningitis, pneumonitis, sarcoidosis, pericarditis, uveitis, and fatal myocarditis. Across 21 dose-ranging trials administering YERVOY at doses of 0.1 to 20 mg/kg (n=2478), the following likely immune-mediated adverse reactions were also reported with <1% incidence unless specified: angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, iritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, arthritis, autoimmune thyroiditis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, ocular myositis, cytopenias (2.5%), and nephritis.

Embryo-Fetal Toxicity

Based on its mechanism of action, YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with YERVOY and for 3 months after the last dose.

Lactation

It is not known whether YERVOY is secreted in human milk. Advise women not to breastfeed during treatment with YERVOY and for 3 months after the last dose.

Common Adverse Reactions

The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%). The most common adverse reactions (≥5%) in patients who received YERVOY at 10 mg/kg were rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache (33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis (16%), decreased appetite (14%), vomiting (13%), and insomnia (10%).

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

Checkmate Trials and Patient Populations

Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032–small cell lung cancer; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma; Checkmate 238–adjuvant treatment of melanoma.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol-Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, Opdivo may not receive regulatory approval from the U.S. Food and Drug Administration or other regulatory authorities for the additional indication described in this release and whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol-Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2018, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol-Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Psorilax:Piano |creme per psoriasi glande

0

Psorilax: prezzo, funziona, recensioni, opinioni, quanto costa

Azienda Bristol-Myers Squibb (NYSE: BMY) ha annunciato oggi che il Ministero della salute, del lavoro e del welfare (MHLW) del Giappone ha approvato Opdivo (nivolumab) per il trattamento di pazienti con carcinoma esofageo avanzato o ricorrente non resecabile che è progredito a seguito di chemioterapia. “data-reagid =” 20 “> Bristol-Myers Squibb Company (NYSE: BMY) ha annunciato oggi il Ministero della salute, del lavoro e del benessere del Giappone (MHLW) ha approvato Opdivo (nivolumab) per il trattamento di pazienti con carcinoma esofageo avanzato o ricorrente non resecabile che è progredito dopo la chemioterapia.

Opdivo come alternativa alla chemioterapia per i pazienti in Giappone con carcinoma esofageo, indipendentemente dal loro stato di PD-L1 “, ha affermato Fouad Namouni, M.D., responsabile dello sviluppo dell'oncologia, Bristol-Myers Squibb.” Questa prima approvazione Opdivo nel carcinoma esofageo esemplifica il nostro impegno nel far progredire le opzioni terapeutiche con il potenziale di estendere la sopravvivenza per i pazienti con tumori gastrointestinali difficili da trattare. “” data-reagid = “22”> “Accanto al nostro partner, Ono Pharmaceutical, siamo orgogliosi di offrire Opdivo come alternativa alla chemioterapia per i pazienti in Giappone con carcinoma esofageo, indipendentemente dal loro stato di PD-L1 “, ha affermato Fouad Namouni, M.D., responsabile dello sviluppo dell'oncologia, Bristol-Myers Squibb.” Questa prima approvazione Opdivo nel carcinoma esofageo è un esempio del nostro impegno a far progredire le opzioni terapeutiche con il potenziale di estendere la sopravvivenza per i pazienti con tumori gastrointestinali difficili da trattare “.

Il cancro esofageo è il settimo tumore più comune e la sesta causa più comune di morte per cancro in tutto il mondo. Il tasso di sopravvivenza relativa a cinque anni è dell'8% o inferiore per i pazienti con diagnosi di malattia metastatica. A livello globale, ogni anno vengono diagnosticati circa 572.000 nuovi casi di carcinoma esofageo, quasi l'80% dei quali si verificano in Asia. In Giappone, vengono diagnosticati circa 20.000 casi e 12.000 decessi sono causati ogni anno dal cancro esofageo. I due tipi più comuni di carcinoma esofageo sono l'adenocarcinoma e il carcinoma a cellule squamose, che rappresentano circa il 90% di tutti i casi di carcinoma esofageo diagnosticati in Giappone. La maggior parte dei casi viene diagnosticata in un ambiente avanzato e ha un impatto sulla vita quotidiana di un paziente, inclusa la sua capacità di mangiare e bere.

Bristol-Myers Squibb: Advancing Oncology Research“data-reactionid =” 34 “>Bristol-Myers Squibb: Advancing Oncology Research

Alla Bristol-Myers Squibb, i pazienti sono al centro di tutto ciò che facciamo. L'obiettivo della nostra ricerca è aumentare la qualità, la sopravvivenza a lungo termine per i pazienti e rendere possibile la cura. Attraverso un approccio multidisciplinare unico basato sulla scienza traslazionale, sfruttiamo la nostra profonda esperienza scientifica nella ricerca oncologica e di immuno-oncologia (I-O) per identificare nuovi trattamenti su misura per le esigenze dei singoli pazienti. I nostri ricercatori stanno sviluppando una pipeline diversificata, appositamente costruita, progettata per colpire diverse vie del sistema immunitario e affrontare le interazioni complesse e specifiche tra il tumore, il suo microambiente e il sistema immunitario. Forniamo innovazione internamente e in collaborazione con il mondo accademico, il governo, i gruppi di difesa e le società di biotecnologia, per contribuire a rendere la promessa di medicinali trasformazionali, come l'I-O, una realtà per i pazienti.

Di Opdivo“data-reactionid =” 36 “>Di Opdivo

INDICAZIONI APPROVATE DALLA FDA USA PER OPDIVO®“data -eagido =” 40 “>INDICAZIONI APPROVATE DALLA FDA USA PER OPDIVO®

IMPORTANTI INFORMAZIONI SULLA SICUREZZA“data-reactionid =” 54 “>IMPORTANTI INFORMAZIONI SULLA SICUREZZA

OPDIVO può causare polmonite immuno-mediata. Sono stati segnalati casi fatali. Monitorare i pazienti per segni con imaging radiografico e per sintomi di polmonite. Somministrare corticosteroidi per polmonite di grado 2 o più grave. Interrompere permanentemente per il Grado 3 o 4 e sospendere fino alla risoluzione per il Grado 2. Nei pazienti in trattamento con monoterapia OPDIVO si sono verificati casi fatali di polmonite immuno-mediata. La polmonite immunomediata si è verificata nel 3,1% (61/1994) dei pazienti. Nei pazienti trattati con OPDIVO 1 mg / kg con YERVOY 3 mg / kg, la polmonite immuno-mediata si è verificata nel 6% (25/407) dei pazienti. Nei pazienti con carcinoma a cellule renali trattati con OPDIVO 3 mg / kg con YERVOY 1 mg / kg, la polmonite immuno-mediata si è verificata nel 4,4% (24/547) dei pazienti. Nei pazienti con mCRC MSI-H / dMMR trattati con OPDIVO 3 mg / kg con YERVOY 1 mg / kg, la polmonite immuno-mediata si è verificata nell'1,7% (2/119) dei pazienti.

In Checkmate 205 e 039, la polmonite, inclusa la malattia polmonare interstiziale, si è verificata nel 6,0% (16/266) dei pazienti trattati con OPDIVO. La polmonite immunomediata si è verificata nel 4,9% (13/266) dei pazienti trattati con OPDIVO: Grado 3 (n = 1) e Grado 2 (n = 12).

OPDIVO può causare colite immuno-mediata. Monitorare i pazienti per segni e sintomi di colite. Somministrare corticosteroidi per grado 2 (di durata superiore a 5 giorni), 3 o 4 coliti. Sospendere la monoterapia con OPDIVO per il grado 2 o 3 e interrompere definitivamente per il grado 4 o la colite ricorrente al momento del riavvio di OPDIVO. Quando somministrato con YERVOY, sospendere OPDIVO e YERVOY per il grado 2 e interrompere definitivamente per il grado 3 o 4 o colite ricorrente. Nei pazienti in terapia con OPDIVO in monoterapia, la colite immuno-mediata si è verificata nel 2,9% (58/1994) dei pazienti. Nei pazienti trattati con OPDIVO 1 mg / kg con YERVOY 3 mg / kg, la colite immuno-mediata si è verificata nel 26% (107/407) dei pazienti, inclusi tre casi fatali. Nei pazienti con carcinoma renale in trattamento con OPDIVO 3 mg / kg con YERVOY 1 mg / kg, si è verificata una colite immuno-mediata nel 10% (52/547) dei pazienti. Nei pazienti con mCRC MSI-H / dMMR trattati con OPDIVO 3 mg / kg con YERVOY 1 mg / kg, la colite immuno-mediata si è verificata nel 7% (8/119) dei pazienti.

In uno studio di fase 3 separato su YERVOY 3 mg / kg, si è verificata enterocolite immuno-mediata grave, grave, pericolosa per la vita o fatale (diarrea di ≥7 feci al di sopra del basale, febbre, ileo, segni peritoneali; grado 3-5) 7%) pazienti. In tutti i pazienti trattati con YERVOY in quello studio (n = 511), 5 (1%) hanno sviluppato perforazione intestinale, 4 (0,8%) sono deceduti a causa di complicanze e 26 (5%) sono stati ricoverati in ospedale per grave enterocolite.

In Checkmate 040, l'epatite immuno-mediata che richiede corticosteroidi sistemici si è verificata nel 5% (8/154) dei pazienti trattati con OPDIVO.

In uno studio di fase 3 separato su YERVOY 3 mg / kg, sono stati riportati 1 caso di sindrome di Guillain-Barré fatale e 1 caso di neuropatia motoria periferica grave (grado 3).

OPDIVO può causare ipofisite immuno-mediata, insufficienza surrenalica immuno-mediata, disturbi autoimmuni della tiroide e diabete mellito di tipo 1. Monitorare i pazienti per segni e sintomi di ipofisite, segni e sintomi di insufficienza surrenalica, funzionalità tiroidea prima e periodicamente durante il trattamento e iperglicemia. Somministrare la sostituzione ormonale come indicato clinicamente e corticosteroidi per ipofisite di grado 2 o superiore. Trattenere per Grado 2 o 3 e interrompere definitivamente per ipofisite di Grado 4. Somministrare corticosteroidi per insufficienza surrenalica di grado 3 o 4. Trattenere per il grado 2 e interrompere definitivamente per l'insufficienza surrenalica di grado 3 o 4. Somministrare la terapia ormonale sostitutiva per l'ipotiroidismo. Avviare la gestione medica per il controllo dell'ipertiroidismo. Sospendere OPDIVO per Grado 3 e interrompere definitivamente per iperglicemia di Grado 4.

Nei pazienti in terapia con OPDIVO in monoterapia, l'ipofisite si è verificata nello 0,6% (12/1994) dei pazienti. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic syndrome.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate study in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients.

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody prior to or after an allogeneic HSCT.

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusions, and dehydration. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY and in 43% of patients receiving sunitinib. The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis; in patients treated with sunitinib, they were pneumonia, pleural effusion, and dyspnea. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients (n=154). The most frequent serious adverse reactions reported in ≥2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, and pneumonia. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients.

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 032, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=245) were fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%), and cough (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) vs sunitinib (n=535) were fatigue (58% vs 69%), rash (39% vs 25%), diarrhea (38% vs 58%), musculoskeletal pain (37% vs 40%), pruritus (33% vs 11%), nausea (30% vs 43%), cough (28% vs 25%), pyrexia (25% vs 17%), arthralgia (23% vs 16%), decreased appetite (21% vs 29%), dyspnea (20% vs 21%), and vomiting (20% vs 28%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent, the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue in patients with severe or life-threatening infusion reactions.

Endocrine: Withhold YERVOY for symptomatic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.

Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment.

All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions.

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-mediated dermatitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically; administer topical or systemic corticosteroids if there is no improvement within 1 week. Withhold YERVOY in patients with moderate to severe signs and symptoms. Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe, life-threatening, or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 YERVOY-treated patients (2.5%); 1 patient (0.2%) died as a result of toxic epidermal necrolysis and 1 additional patient required hospitalization for severe dermatitis. There were 63 patients (12%) with moderate (Grade 2) dermatitis. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated dermatitis occurred in 19 patients (4%). There were 99 patients (21%) with moderate Grade 2 dermatitis.

Immune-mediated neuropathies, including fatal cases, can occur with YERVOY. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities). Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities), such as Guillain-Barré-like syndromes. Institute medical intervention as appropriate for management for severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. In patients receiving YERVOY 3 mg/kg in MDX010-20, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-5 immune-mediated neuropathy occurred in 8 patients (2%); the sole fatality was due to complications of Guillain-Barré syndrome. Moderate Grade 2 immune-mediated neuropathy occurred in 1 patient (0.2%).

Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY. Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated. Monitor clinical chemistries, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY in symptomatic patients and consider referral to an endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 YERVOY-treated patients (1.8%). All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 patients (2.3%) and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing's syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 2.5 months and ranged up to 4.4 months after the initiation of YERVOY. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated endocrinopathies occurred in 39 patients (8%) and Grade 2 immune-mediated endocrinopathies occurred in 93 patients (20%). Of the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of the 39 patients were hospitalized for immune-mediated endocrinopathies. Of the 93 patients with Grade 2 immune-mediated endocrinopathy, 74 had primary hypopituitarism (associated with 1 or more secondary endocrinopathy, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 9 had primary hypothyroidism, 3 had hyperthyroidism, 3 had thyroiditis with hypo- or hyperthyroidism, 2 had hypogonadism, 1 had both hyperthyroidism and hypopituitarism, and 1 subject developed Graves’ ophthalmopathy. The median time to onset of Grade 2 immune-mediated endocrinopathy was 2.1 months (range: 9 days-19.3 months).

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions. Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity. Immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss. Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss. Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive a CTLA-4 receptor blocking antibody either before or after allogeneic hematopoietic stem cell transplantation (HSCT). Follow patients closely for evidence of GVHD and intervene promptly. Consider the benefit versus risks of treatment with a CTLA-4 receptor blocking antibody after allogeneic HSCT. In MDX010-20, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients: cytopenias, nephritis, pneumonitis, meningitis, pericarditis, uveitis, and iritis. In CA184-029, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients unless specified: cytopenias, eosinophilia (2.1%), pancreatitis (1.3%), meningitis, pneumonitis, sarcoidosis, pericarditis, uveitis, and fatal myocarditis. Across 21 dose-ranging trials administering YERVOY at doses of 0.1 to 20 mg/kg (n=2478), the following likely immune-mediated adverse reactions were also reported with <1% incidence unless specified: angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, iritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, arthritis, autoimmune thyroiditis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, ocular myositis, cytopenias (2.5%), and nephritis.

Based on its mechanism of action, YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with YERVOY and for 3 months after the last dose.

It is not known whether YERVOY is secreted in human milk. Advise women not to breastfeed during treatment with YERVOY and for 3 months after the last dose.

The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%). The most common adverse reactions (≥5%) in patients who received YERVOY at 10 mg/kg were rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache (33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis (16%), decreased appetite (14%), vomiting (13%), and insomnia (10%).

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PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy.

This approval is based on the Phase 3 ATTRACTION-3 trial, which evaluated Opdivo versus chemotherapy (docetaxel or paclitaxel) for the treatment of patients with unresectable advanced or recurrent esophageal squamous cell carcinoma (ESCC) refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs. For the primary endpoint of overall survival (OS), Opdivo demonstrated a 23% reduction in the risk of death (Hazard Ratio (HR) 0.77; 95% Confidence Interval (CI): 0.62 to 0.96; p=0.019) and a 2.5-month improvement in median OS (10.9 months (95% CI: 9.2 to 13.3)) compared with chemotherapy (8.4 months (95% CI: 7.2 to 9.9)). The safety profile of Opdivo in this trial was consistent with previously reported studies in solid tumors. The ATTRACTION-3 trial was sponsored by Ono Pharmaceutical Co. Ltd. of Japan, Bristol-Myers Squibb’s development partner for Opdivo.

“Alongside our partner, Ono Pharmaceutical, we are proud to offer Opdivo as an alternative to chemotherapy for patients in Japan with esophageal cancer, regardless of their PD-L1 status,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. “This first-ever approval of Opdivo in esophageal cancer exemplifies our commitment to advancing treatment options with the potential to extend survival for patients with difficult-to-treat gastrointestinal cancers.”

About ATTRACTION-3

ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) is a Phase 3, multi-center, randomized, open-label global study, evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for patients with esophageal cancer refractory or intolerant to first-line combination therapy with fluoropyrimidine and platinum-based drugs. Patient enrollment occurred predominantly in Asia, with the remainder in the United States and Europe. Patients were treated until disease progression or unacceptable toxicity. The primary endpoint of the trial was OS. Secondary endpoints include investigator-assessed objective response rate, progression-free survival, disease control rate, duration of response and safety.

Patients treated in the Opdivo arm showed 12- and 18-month OS rates of 47% (95% CI: 40 to 54) and 31% (95% CI: 24 to 37), respectively, versus 34% (95% CI: 28 to 41) and 21% (95% CI: 15 to 27) among patients in the chemotherapy arm. Survival benefit with Opdivo was observed regardless of tumor PD-L1 expression levels. An exploratory analysis of patient-reported outcomes showed significant overall improvement in quality of life with Opdivo versus chemotherapy.

Fewer treatment-related adverse events (TRAEs) were reported with Opdivo versus chemotherapy, with a rate of 66% of any grade TRAEs for patients receiving Opdivo compared to 95% for patients receiving chemotherapy. Patients in the Opdivo arm also experienced a lower incidence of Grade 3 or 4 TRAEs compared to those in the chemotherapy arm (18% versus 63%), and the percentage of patients experiencing TRAEs leading to discontinuation was the same in both arms (9%).

Data from the study were featured in a Presidential Symposium during the European Society for Medical Oncology 2019 Annual Congress and simultaneously published in The Lancet Oncology.

About Esophageal Cancer

Esophageal cancer is the seventh most common cancer and the sixth most common cause of death from cancer worldwide. The five-year relative survival rate is 8% or less for patients diagnosed with metastatic disease. Globally, an estimated 572,000 new cases of esophageal cancer are diagnosed each year, nearly 80% of which occur in Asia. In Japan, approximately 20,000 cases are diagnosed and 12,000 deaths are caused by esophageal cancer every year. The two most common types of esophageal cancer are adenocarcinoma and squamous cell carcinoma, the latter accounting for approximately 90% of all esophageal cancer cases diagnosed in Japan. The majority of cases are diagnosed in the advanced setting and impact a patient’s daily life, including their ability to eat and drink.

Bristol-Myers Squibb: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO®

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy, and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Neuropathies

In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin Adverse Reactions and Dermatitis

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic syndrome.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate study in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusions, and dehydration. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY and in 43% of patients receiving sunitinib. The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis; in patients treated with sunitinib, they were pneumonia, pleural effusion, and dyspnea. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients (n=154). The most frequent serious adverse reactions reported in ≥2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, and pneumonia. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 032, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=245) were fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%), and cough (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) vs sunitinib (n=535) were fatigue (58% vs 69%), rash (39% vs 25%), diarrhea (38% vs 58%), musculoskeletal pain (37% vs 40%), pruritus (33% vs 11%), nausea (30% vs 43%), cough (28% vs 25%), pyrexia (25% vs 17%), arthralgia (23% vs 16%), decreased appetite (21% vs 29%), dyspnea (20% vs 21%), and vomiting (20% vs 28%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent, the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Recommended Dose Modifications

Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue in patients with severe or life-threatening infusion reactions.

Endocrine: Withhold YERVOY for symptomatic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.

Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment.

All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions.

Immune-Mediated Enterocolitis

Immune-mediated enterocolitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms. Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent). Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients. Consider adding anti-TNF or other immunosuppressant agents for management of immune-mediated enterocolitis unresponsive to systemic corticosteroids within 3-5 days or recurring after symptom improvement, if other causes are excluded. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 YERVOY-treated patients (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 YERVOY-treated patients (5%). Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis. Infliximab was administered to 5 (8%) of the 62 patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-5 immune-mediated enterocolitis occurred in 76 patients (16%) and Grade 2 enterocolitis occurred in 68 patients (14%). Seven (1.5%) developed intestinal perforation and 3 patients (0.6%) died as a result of complications.

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

Immune-mediated hepatitis, including fatal cases, can occur with YERVOY. Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution. Withhold YERVOY in patients with Grade 2 hepatotoxicity. Permanently discontinue YERVOY in patients with Grade 3-4 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5× the ULN or total bilirubin elevations >3× the ULN; Grade 3-5) occurred in 8 YERVOY-treated patients (2%), with fatal hepatic failure in 0.2% and hospitalization in 0.4%. An additional 13 patients (2.5%) experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5× but ≤5× the ULN or total bilirubin elevation >1.5× but ≤3× the ULN; Grade 2). In a dose-finding trial, Grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent YERVOY (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID). In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated hepatitis occurred in 51 patients (11%) and moderate Grade 2 immune-mediated hepatitis occurred in 22 patients (5%). Liver biopsy performed in 6 patients with Grade 3-4 hepatitis showed evidence of toxic or autoimmune hepatitis.

Immune-Mediated Dermatitis

Immune-mediated dermatitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically; administer topical or systemic corticosteroids if there is no improvement within 1 week. Withhold YERVOY in patients with moderate to severe signs and symptoms. Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe, life-threatening, or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 YERVOY-treated patients (2.5%); 1 patient (0.2%) died as a result of toxic epidermal necrolysis and 1 additional patient required hospitalization for severe dermatitis. There were 63 patients (12%) with moderate (Grade 2) dermatitis. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated dermatitis occurred in 19 patients (4%). There were 99 patients (21%) with moderate Grade 2 dermatitis.

Immune-Mediated Neuropathies

Immune-mediated neuropathies, including fatal cases, can occur with YERVOY. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities). Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities), such as Guillain-Barré-like syndromes. Institute medical intervention as appropriate for management for severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. In patients receiving YERVOY 3 mg/kg in MDX010-20, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-5 immune-mediated neuropathy occurred in 8 patients (2%); the sole fatality was due to complications of Guillain-Barré syndrome. Moderate Grade 2 immune-mediated neuropathy occurred in 1 patient (0.2%).

Immune-Mediated Endocrinopathies

Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY. Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated. Monitor clinical chemistries, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY in symptomatic patients and consider referral to an endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. In patients receiving YERVOY 3 mg/kg in MDX010-20, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 YERVOY-treated patients (1.8%). All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 patients (2.3%) and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 2.5 months and ranged up to 4.4 months after the initiation of YERVOY. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated endocrinopathies occurred in 39 patients (8%) and Grade 2 immune-mediated endocrinopathies occurred in 93 patients (20%). Of the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of the 39 patients were hospitalized for immune-mediated endocrinopathies. Of the 93 patients with Grade 2 immune-mediated endocrinopathy, 74 had primary hypopituitarism (associated with 1 or more secondary endocrinopathy, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 9 had primary hypothyroidism, 3 had hyperthyroidism, 3 had thyroiditis with hypo- or hyperthyroidism, 2 had hypogonadism, 1 had both hyperthyroidism and hypopituitarism, and 1 subject developed Graves’ ophthalmopathy. The median time to onset of Grade 2 immune-mediated endocrinopathy was 2.1 months (range: 9 days-19.3 months).

Other Immune-Mediated Adverse Reactions

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions. Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity. Immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss. Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss. Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive a CTLA-4 receptor blocking antibody either before or after allogeneic hematopoietic stem cell transplantation (HSCT). Follow patients closely for evidence of GVHD and intervene promptly. Consider the benefit versus risks of treatment with a CTLA-4 receptor blocking antibody after allogeneic HSCT. In MDX010-20, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients: cytopenias, nephritis, pneumonitis, meningitis, pericarditis, uveitis, and iritis. In CA184-029, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients unless specified: cytopenias, eosinophilia (2.1%), pancreatitis (1.3%), meningitis, pneumonitis, sarcoidosis, pericarditis, uveitis, and fatal myocarditis. Across 21 dose-ranging trials administering YERVOY at doses of 0.1 to 20 mg/kg (n=2478), the following likely immune-mediated adverse reactions were also reported with <1% incidence unless specified: angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, iritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, arthritis, autoimmune thyroiditis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, ocular myositis, cytopenias (2.5%), and nephritis.

Embryo-Fetal Toxicity

Based on its mechanism of action, YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with YERVOY and for 3 months after the last dose.

Lactation

It is not known whether YERVOY is secreted in human milk. Advise women not to breastfeed during treatment with YERVOY and for 3 months after the last dose.

Common Adverse Reactions

The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%). The most common adverse reactions (≥5%) in patients who received YERVOY at 10 mg/kg were rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache (33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis (16%), decreased appetite (14%), vomiting (13%), and insomnia (10%).

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

Checkmate Trials and Patient Populations

Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032–small cell lung cancer; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma; Checkmate 238–adjuvant treatment of melanoma.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol-Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, Opdivo may not receive regulatory approval from the U.S. Food and Drug Administration or other regulatory authorities for the additional indication described in this release and whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol-Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2018, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol-Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Psorilax:opinioni |pso crema dermaffine recensioni forum psoriasi

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Psorilax: prezzo, funziona, recensioni, opinioni, dove si compra

Bruxelles, 23 febbraio 2020 (Thomson StreetEvents) – Trascrizione modificata della teleconferenza o presentazione degli utili della UCB SA giovedì 20 febbraio 2020 alle 13:00:00 GMT

UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices e Executive VP

Redburn (Europe) Limited, Divisione Ricerca – Analista di ricerca lato vendita biofarmaceutica

Jefferies LLC, Divisione Ricerca – Senior Equity Analyst & European Pharmaceuticals Analyst

* Richard J. Parkes

Sanford C. Bernstein & Co., LLC., Divisione Ricerca – Analista di ricerca

Benvenuti alla teleconferenza UCB. (Istruzioni per l'operatore) Si noti che questa teleconferenza verrà registrata e che un replay del webcast sarà disponibile più tardi oggi sul sito Web della UCB, nella sezione Investitori.

Sono lieto di presentare la signora Antje Witte, responsabile delle relazioni con gli investitori, che sarà moderatrice di questa conferenza. Signora Witte, il pavimento è tuo.

Grazie mille (Qayyum). Buon pomeriggio e buongiorno anche da parte mia. Grazie per esserti unito a noi per la nostra conference call sui risultati dell'intero anno 2019. Prima di passare a Jean-Christophe Tellier, il nostro CEO, che presenterà anche a te i relatori, vorrei ricordarti che questa presentazione, la sessione di domande e risposte e le diapositive della presentazione sono sotto il nostro disclaimer e dichiarazioni di sicurezza, trovi sulla diapositiva 2, che ti chiedo gentilmente di leggere attentamente.

E con ciò, vorrei consegnare a Jean-Christophe, CEO di UCB.

Grazie Antje. Buon pomeriggio, buongiorno a tutti e grazie per aver aderito alla nostra call sui risultati dell'intero anno. Come avrete visto nel comunicato stampa già questa mattina, siamo lieti della nostra performance del 2019. Questi buoni progressi nel nostro percorso di crescita strategica hanno rafforzato la nostra capacità di garantire una crescita sostenibile. Come indicato da Antje, vorrei esaminare l'ordine del giorno di questa chiamata. Ma prima di ciò, forse menzionando che con questo obiettivo in mente, stiamo rafforzando il nostro modello operativo per garantire più agilità e collaborazioni all'interno dell'organizzazione. E questa evoluzione si riflette nella nuova composizione del Comitato Esecutivo che abbiamo comunicato anche questa mattina nel comunicato stampa. Il Comitato Esecutivo, che è diventato più piccolo con ruoli più trasversali tra le imprese e le regioni, e hai alcune delle illustrazioni di ciò nell'agenda che è sullo schermo in questo momento.

Quindi prendendo la parola dopo di me, Emmanuel Caeymaex commenterà la nostra attività di immunologia. Ora abbiamo incluso Evenity nel nostro pilastro dell'immunologia e nel suo nuovo ruolo, Emmanuel sarà anche responsabile degli Stati Uniti, quindi Charl Van Zyl parlerà del franchise di neurologia, concentrandosi sull'epilessia. Charl era in precedenza responsabile della nostra operazione ed è ora responsabile del nostro pilastro di neurologia e delle nostre geografie europee e internazionali. E infine, Detlef ti guiderà attraverso i finanziari come al solito. Commenterà le prospettive per il 2020 e il nostro medio termine: nuove indicazioni a medio termine. Come sapete, e come precedentemente annunciato dopo un mandato di grande successo, Detlef si ritirerà da UCB nella prima metà del 2020. E come avrete visto nel comunicato stampa, stiamo continuando a cercare un successore e fiduciosi di poter – saremo in grado di farlo entro la fine della prima metà di quest'anno.

Quindi, come sapete, la nostra ambizione per i pazienti è di consentire loro di vivere la vita che desiderano e di non avere la vita definita da una malattia. Questa è l'ancora di ciò che facciamo, il nostro principale senso dello scopo e la giustificazione della nostra strategia di valore per il paziente. Rafforziamo costantemente il nostro senso dello scopo al fine di riflettere l'impegno per uno sviluppo sostenibile, e questo è lo scopo di questa diapositiva. Innanzitutto, vogliamo concentrarci sulle innovazioni in R&S, il che significa per noi, e questa è la nostra ambizione per il valore del paziente. Significa per noi offrire una soluzione differenziata con esiti unici per aiutare specifiche popolazioni di pazienti a raggiungere i loro obiettivi. Ma crea anche per loro la migliore esperienza individuale possibile.

Inoltre, significa anche ampliare l'accesso, e questo è il secondo pilastro che vedete qui in questa diapositiva. Accesso ai pazienti che potrebbero aver bisogno delle soluzioni che possiamo proporre loro in un modo che sia praticabile per loro, per la comunità, la società e per UCB. Ma valore per i pazienti, e questo è il terzo pilastro, valore per i pazienti significa anche offrire ai dipendenti della UCB il miglior ambiente per loro di essere al meglio, e in particolare in termini di salute, sicurezza e benessere. E infine, vogliamo fornire ciò minimizzando la nostra impronta ambientale su tutta la catena del valore.

Quindi, partendo da questo viaggio, dove siamo oggi? Come ricorderete, nel 2019 siamo entrati nella nostra seconda fase del nostro percorso strategico, la fase di spesa accelerata. Volevamo accelerare il nostro ciclo e sviluppare agilità. Volevamo espanderci in nuove popolazioni di pazienti e volevamo anche sfruttare la nostra flessibilità strategica identificando e agendo su potenziali opportunità. Quindi cosa abbiamo consegnato nel 2019. Innanzitutto, abbiamo aggiunto 2 nuovi prodotti nel nostro portafoglio per la nuova popolazione di pazienti. L'uniformità con il nostro partner, Amgen, nell'osteoporosi, è stata lanciata negli Stati Uniti e in Giappone e approvata in Corea del Sud, Australia, Canada e Europa. Questa è una terapia innovativa di prima classe per la costruzione di ossa nell'osteoporosi. Secondo nuovo prodotto che abbiamo aggiunto al nostro portafoglio, Nazolam, abbiamo lanciato a dicembre negli Stati Uniti, uno spray nasale per i cluster convulsivi. Abbiamo anche – e questo è il secondo elemento che vedi sulla diapositiva, abbiamo anche continuato ad accelerare e rafforzato significativamente la nostra pipeline con già 3 studi clinici di fase III positivi per bimekizumab nella psoriasi.

E 5 nuovi programmi di Fase III in – iniziati nel 2019: Bimekizumab nell'artrite psoriasica e nella spondiloartrite assiale; padsevonil nell'epilessia refrattaria; e rozanolixizumab nella miastenia grave e nella porpora trombocitopenica immune. E, ultimo ma non meno importante, abbiamo anche sfruttato la nostra flessibilità strategica che avevamo nelle nostre priorità. Lo scorso ottobre, abbiamo annunciato di aver raggiunto un accordo per l'acquisizione di Ra Pharma. Volevamo unire le forze per migliorare la nostra opzione per il trattamento delle persone che soffrono di miastenia grave e altre malattie rare. Charl ne commenterà più avanti. Tuttavia, poiché abbiamo condiviso con te e vogliamo confermare che siamo fiduciosi che saremo in grado di chiudere questo accordo nel primo trimestre 2020. Ma agire sulle potenziali opportunità e collegarci con diversi partner possibili, è anche raggiunto attraverso altri elementi e tu hai alcuni esempi qui.

Abbiamo creato una collaborazione pionieristica di ricerca e sviluppo di genomica di 5 anni con la società dell'epilessia per comprendere meglio la malattia, creare una nuova tassonomia e potenzialmente comprendere meglio i biomarcatori e come sviluppare un trattamento più appropriato per la popolazione di pazienti (impercettibili). Con SeizeIT, abbiamo concesso un accordo di progetto del consorzio per sviluppare un dispositivo di rilevazione delle crisi epilettiche discreto e personalizzato. E con il King's College di Londra, abbiamo firmato una collaborazione di ricerca e sviluppo di 3 anni. Quindi puoi vedere che non stiamo solo guardando alle opportunità esterne dal punto di vista delle fusioni e acquisizioni, ma stiamo anche rafforzando le nostre potenziali collaborazioni con altre parti interessate chiave nelle aree di nostro interesse. Quindi stiamo procedendo bene sui nostri percorsi e stiamo costruendo il nostro futuro.

Ma, naturalmente, siamo in grado di farlo, principalmente perché stiamo offrendo i nostri driver chiave per la crescita, ed è grazie al risultato di oggi, è grazie alle prestazioni di oggi che possiamo continuare a rafforzare un futuro sostenibile. Basandoci sul sesto anno consecutivo di crescita, in alto e in basso con un CAGR delle entrate dell'8% e un CAGR dell'EBITDA del 19% nel periodo che vedete nelle diapositive, abbiamo creato una piattaforma molto forte per il futuro. Quindi – e qui hai i principali risultati per prodotto in termini di crescita e numeri assoluti, allora Charl ed Emmanuel commenteranno ulteriormente. Ciò ci ha guidato e migliorato la nostra guida a medio termine.

Quindi siamo soddisfatti delle forti prestazioni del '19. Siamo lieti di essere stati in grado di continuare a crescere, che ci consentono di accelerare la nostra pipeline, ci consentono di costruire e rafforzare il nostro futuro e fornire valore sostenibile per i pazienti.

Quindi, con questo in mente, vorrei passare ora a Emmanuel.

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (4)

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Grazie, Jean-Christophe, e grazie a tutti per esservi uniti. Sono molto lieto di commentare le prestazioni e lo stato di avanzamento delle nostre 3 risorse immunologiche, tra cui Cimzia e i suoi driver di crescita, un aggiornamento su progressi e contesto per bimekizumab e anche sul lancio di Evenity. Partiamo quindi da Cimzia e dai componenti della forte crescita valutaria costante del 14% che avete visto e anche da come questo ci sta portando ad aumentare la nostra guida di vendita di punta per il marchio a 2 miliardi di euro. Quindi il primo punto, è importante notare che la crescita del 2019 è interamente guidata dal volume. Quindi non vi è alcun contributo positivo del prezzo netto. Tutte le aree geografiche hanno contribuito a questa crescita, come puoi vedere, e negli Stati Uniti, sia la formulazione liofilizzata che la presentazione (PFS) sono in crescita. Quindi, come sapete, lyo è destinato all'iniezione in ufficio e abbiamo ottenuto notevoli guadagni di quote di mercato grazie all'ottimo accesso in prima linea.

Ma anche una proposta di valore molto forte con un prodotto a temperatura ambiente che può essere iniettato rapidamente, rispetto alla maggior parte dei prodotti infusi nella categoria. È importante notare anche che l'uso e la copertura della formulazione liofilizzata non è puramente Medicare Parte B. In effetti, il 40% di questa formulazione è coperto da assicuratori commerciali, e questa è la parte in più rapida crescita del 2. Ciò che è stato eccezionale in Il 2019 vedrà crescere nuovamente la nostra siringa preriempita, che è stata alimentata dal nostro lancio nella psoriasi e dal lancio anticipato di axSpA non radiografico. Abbiamo aperto molto accesso a quei pazienti. E non vedo l'ora che arrivi il prossimo anno a vederlo completamente tradotto nella nostra crescita delle vendite.

È interessante notare anche che l'Europa è cresciuta nonostante la concorrenza indiretta dei biosimilari, incidendo sia sul prezzo netto sia sui volumi. Quella crescita è davvero ridotta ad alcuni punti. Il primo è la resilienza e l'aumento delle quote nelle donne in età fertile, che viene sempre più riconosciuto come un segmento di pazienti che necessitano di soluzioni specifiche. E il secondo sono i primi giorni del lancio della nostra psoriasi in Europa.

Quindi i mercati internazionali sono stati forti, come puoi vedere, ne siamo molto soddisfatti, ed è per le stesse ragioni dell'Europa. Quindi, se ora guardiamo sul lato destro, puoi vedere che i driver di crescita in termini di popolazioni di pazienti oltre alle donne in età fertile che ho menzionato e che tagliano la nostra psoriasi con circa 4 punti, come una nuova voce. E poi anche axSpA, che è sia axSpA non radiografico negli Stati Uniti, ma anche un effetto alone generale con i grandi dati che siamo stati in grado di comunicare: generare e comunicare l'anno scorso in tutto il mondo.

In prospettiva, siamo fiduciosi che Cimzia raggiungerà o supererà il picco delle vendite di 2 miliardi di euro. Riteniamo che i driver della crescita multipla compenseranno più che altro l'erosione del volume e dei prezzi legata alla concorrenza sottocutanea in tutto il TNF simile al di fuori degli Stati Uniti e anche per le nuove modalità di azione che entrano nelle varie indicazioni. E così solo per ricapitolare Cimzia, abbiamo la psoriasi, in cui Europa e Giappone contribuiranno alle vendite in contanti in futuro. Abbiamo axSpA, dove ci sono molte passerelle, molte esigenze insoddisfatte e un sacco di market shaping da fare, specialmente negli Stati Uniti. Ulteriori guadagni e certamente, resilienza nelle donne in età fertile, in cui Cimzia non è facilmente sostituibile , rappresenta una terza fonte di crescita futura e credo che il segmento di iniezione in ufficio negli Stati Uniti abbia anche spazio per ulteriori guadagni di quote di mercato e per la nostra espansione geografica con un inizio molto promettente in Cina, che oggi è un piccolo mercato , ma un mercato di importanza strategica a più lungo termine.

Quindi tutto ciò è una buona preparazione e una solida base su cui basarci mentre ci prepariamo a presentare e infine, si spera, a commercializzare bimekizumab sia in dermatologia che in reumatologia. Come puoi vedere qui, bimekizumab è ora in 4 programmi di sviluppo clinico in fase avanzata, per un totale di 10 studi in fase III e IIIb. E stiamo aggiungendo l'idradenite suppurativa come indicazione target per bimekizumab, e ci tornerò un po 'più tardi. Ma forse, per prima cosa, come promemoria, il bimekizumab è un anticorpo monoclonale, che inibisce in modo importante e selettivo 2 citochine: interleuchina-17A e interleuchina-17F. E quindi sappiamo che nella biologia IL-17 umana, sia il 17A che il 17F hanno una funzione pro-infiammatoria e che entrambi si sinergizzano con altre citochine pro-infiammatorie, come ad esempio il TNF.

Pertanto, il blocco di A e F dovrebbe portare a un maggior numero di pazienti che ottengono risposte sostenute e clinicamente adeguate, raggiungendo i loro obiettivi. E questo è ciò che ha suggerito lo studio di Fase II, ed è quello che intendiamo confermare con gli studi di Fase III in corso. Quindi la psoriasi sta avanzando molto bene con il 3 su 3 nel quarto trimestre dell'anno scorso. Quindi siamo molto entusiasti di questo. E siamo anche molto lieti di condividere con voi che i risultati dettagliati dei primi 2 studi, BE VIVID ed BE READY, saranno condivisi in presentazioni orali in ritardo presso l'American Academy of Dermatology il 21 marzo di quest'anno.

E quindi questo include lo studio di superiorità rispetto a Stelara e uno studio placebo che valuta il dosaggio sul prodotto. I risultati completi del terzo studio di Fase III BE SURE sono diventati disponibili dopo la scadenza per la presentazione dei DAE, e quindi abbiamo in programma di condividere questi risultati nella seconda metà dell'anno durante un'importante conferenza medica di dermatologia. Posso anche confermare che ci aspettiamo i risultati dello studio BE READY e di superiorità rispetto a Cosentyx entro la fine del secondo trimestre, che dovrebbe essere appena prima di presentare il bimekizumab con i regolatori americani ed europei in estate. I programmi PsA e axSpA, che sono iniziati l'anno scorso, stanno reclutando per pianificare e ci aspettiamo i migliori risultati entro la fine del prossimo anno. Siamo lieti che i risultati della Fase IIb di PsA siano stati pubblicati all'inizio di questo mese su The Lancet. È già disponibile online. È chiaramente una pubblicazione medica di alto profilo e di grande impatto e questo riconoscimento del potenziale della rilevanza clinica della doppia neutralizzazione di 17A e 17F nell'artrite psoriasica è molto incoraggiante.

Quindi ora una breve parola sull'idradenite suppurativa. Chiamiamolo HS. Quindi è un'area di profonda necessità insoddisfatta del paziente. E quindi non vediamo l'ora di fare la differenza per questi pazienti e i loro fornitori. È davvero una malattia infiammatoria cronica debilitante della pelle del follicolo pilifero con lesioni dolorose e spesso ascessi sotto le ascelle, l'area genitale, l'inguine, i glutei e il seno. In realtà non è raro. Si stima che la prevalenza globale sia vicina all'1%. E così questa malattia in genere inizia nei primi anni '20, prevalentemente nelle donne ed è associata a molteplici comorbidità, tra cui ansia, depressione, imbarazzo e altre condizioni infiammatorie. Quindi i pazienti non sono ben serviti dal sistema sanitario e nemmeno farmacologicamente, dove è approvato un solo farmaco per questa condizione, e questo è HUMIRA.

Quindi è davvero un'area emergente, ma un'area di necessità insoddisfatte molto elevate. E così la base per il nostro programma di Fase III è il riuscito studio di prova di concetto di Fase II, che abbiamo condotto con bimekizumab. I risultati sono stati chiaramente positivi. Li abbiamo condivisi alla recente riunione di hidradenitis suppurativa, la riunione della Fondazione europea HS, all'inizio di febbraio. E sulla base di questi risultati molto incoraggianti, stiamo iniziando 2 studi identici, controllati con placebo da 1 anno, mentre parliamo. E stiamo testando 3 regimi di dose di bimekizumab e per consentire l'inclusione di pazienti precedentemente esposti a HUMIRA.

Quindi la domanda potrebbe essere, ovviamente, in uno spazio ampio, in crescita e competitivo, come potremmo valutare il potenziale di bimekizumab? E ci sono probabilmente fattori importanti che dovremmo considerare quando selezioniamo i medicinali per questi pazienti in tutte queste malattie. Quindi ti invitiamo a esaminare 4 fattori. Il primo è che c'è una significativa intersezione e progressione tra le malattie, certamente, tra la psoriasi e la PsA, che è ben riconosciuta. Ma anche tra l'artrite psoriasica e axSpA, c'è l'intersezione. E c'è una serie emergente di articoli scientifici che indicano pazienti axSpA che soffrono di SA e viceversa, forse non in grandi proporzioni, ma certamente nell'intervallo del 10%. E questo forse indica una comune patobiologia, che dovrebbe essere incoraggiante per un farmaco come il bimekizumab con i suoi risultati di fase IIb axSpA. Quindi, se i dati di Fase III e IIIb confermano i nostri risultati di Fase II, il bimekizumab può essere considerato un'opzione molto interessante attraverso gli spettri di queste malattie dagli operatori sanitari, ma anche dai pagatori.

Quindi accanto a questo, ovviamente, e pensando alla prima indicazione che speriamo colpisca la psoriasi del mercato, stiamo anche cercando velocità per una risposta significativa. Molto spesso per i pazienti, ci vogliono mesi prima di sapere se le iniezioni che stanno facendo funzionano davvero. C'è anche una profondità di risposta. Quindi possiamo eliminare completamente i sintomi e consentire ai pazienti di dimenticare completamente la loro malattia. E quindi il quarto criterio potrebbe essere la durata dell'effetto clinico desiderato perché c'è molta ansia dei sintomi che ritornano, e questa è sicuramente un'area, di cui i clinici si lamentano costantemente, è la perdita di efficacia con molti degli agenti disponibili . Quindi questo tipo di arrotondamento per bimekizumab. Vorrei forse condividere brevemente alcuni punti su Evenity, che potresti anche aver sentito nella chiamata di Amgen se hai partecipato. Così, come ha affermato Jean-Christophe, Evenity è un innovativo trattamento di formazione ossea per le donne in postmenopausa con osteoporosi e ad alto rischio di fratture.

Colpisce 75 milioni di persone negli Stati Uniti, in Europa e in Giappone e 1 donna su 3 con più di 50 anni subirà una frattura. Quindi, nonostante ciò sia comune, solo il 20% dei pazienti con frattura attualmente riceve qualsiasi tipo di trattamento post-frattura. Quindi c'è un enorme bisogno insoddisfatto qui. E la domanda, ovviamente, è chi è il più alto rischio di una grave frattura osteoporotica. E chiaramente, è – quelle donne che hanno avuto una frattura che hanno una probabilità 5 volte superiore di soffrire di una seconda frattura entro il prossimo anno o 2. Quindi questo è un indicatore abbastanza importante. Ed è anche qui che posizioniamo Evenity insieme ai nostri partner, Amgen e Astellas. Queste fratture possono essere eventi che cambiano la vita. Quindi, quindi, è davvero necessario agire, non solo in termini di trattamento, ma anche nello screening dei pazienti e nell'assicurarsi che i pazienti vengano inviati ai medici appropriati.

Quindi, con Evenity, si tratta più di far identificare e curare i pazienti che di spostare altri medicinali. Pensiamo che con i suoi risultati di costruzione ossea rapidi e senza precedenti e la riduzione del rischio di fratture, Evenity possa essere visto come un trattamento di 12 mesi prima di passare alla terapia cronica, e siamo molto soddisfatti dell'approvazione EMEA di dicembre e del successo del lancio finora. Circa 55.000 pazienti sono già stati trattati con Evenity nel 2019 in Giappone e negli Stati Uniti, e abbiamo pianificato e siamo pronti a lanciare Evenity in Germania a marzo con il supporto di Amgen e di ottenere l'accesso in tutta Europa durante il resto di questo anno.

Quindi, per concludere sul portafoglio di immunologia, abbiamo una forte crescita con Cimzia. Non vediamo l'ora di un'ulteriore crescita negli anni a venire sulla base di più driver. Con bimekizumab abbiamo un modo d'azione unico che si sta traducendo in interessanti risultati clinici. E quindi non vediamo l'ora di condividere i risultati della Fase III e scoprire i risultati della Fase III mentre procediamo. E Evenity inizia in modo molto forte nei mercati sottosviluppati. E quindi è davvero un importante impegno a lungo termine che abbiamo nei confronti di questi pazienti.

E con questo, vorrei consegnare il mio collega, Charl.

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU / International (5)

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Grazie Emmanuel. Quindi, prima di tutto, buongiorno, buon pomeriggio a tutti e partecipare alla chiamata oggi. Farò alcune osservazioni di apertura rapida prima di entrare in alcuni dettagli più specifici. E prima di tutto, voglio esprimere la mia fiducia su come stiamo costruendo un franchising neurologico molto diversificato nel breve e medio termine. E ci sono 3 messaggi importanti che voglio solo trasmettere e 3 elementi fondamentali per il nostro franchising di neurologia. Prima di tutto, stiamo iniziando con una solida base nell'epilessia e vediamo che la crescita a breve termine a medio termine continua ad essere alimentata da alcuni dei nostri marchi principali nel nostro franchising di epilessia.

In secondo luogo, a medio termine, vediamo anche una piacevole espansione nella neuroinfiammazione, che è un'area di malattie rare, con un alto grado di bisogno insoddisfatto. E qui, abbiamo 2 risorse molto forti in questo caso, il rozimab e la nostra acquisizione di Ra Pharma con 2 modalità che potrebbero darci alcune posizioni forti nelle malattie rare e una varietà di aree insoddisfatte per la crescita futura in quest'area in il medio termine. E infine, a lungo termine, abbiamo una base molto solida nella neurodegenerazione. Chiaramente, abbiamo un'eredità in Neupro e una profonda comprensione del Parkinson, ma abbiamo anche una forte competenza scientifica e comprensione di quest'area, che ci porta ad alcuni nuovi trattamenti potenzialmente qui con lo studio di conferma anche per l'anti-tau in PSP .

Quindi, su questi 3 orizzonti, vediamo una posizione molto ben bilanciata nella crescita sia a breve che a medio e lungo termine, e sono molto fiducioso di essere in una posizione forte nei prossimi anni nel nostro franchising di neurologia.

Quindi, se andiamo un po 'più a fondo nella discussione sull'epilessia, e voglio solo qui esprimere nuovamente la mia fiducia sulla nostra posizione che abbiamo nell'epilessia, e stiamo davvero qui vedendo un portafoglio molto forte di scelte per i pazienti e per i medici per trattare le diverse fasi dell'epilessia. Abbiamo una posizione molto forte nell'area controllata con marchi come Vimpat, il nostro retaggio di Keppra e anche una forte crescita emergente di Briviact. Poi abbiamo un nuovo lancio, come aveva detto Jean-Christophe, nell'area della ricaduta convulsiva con Nazolam in un'area di necessità insoddisfatta molto elevata, e vediamo alcune prestazioni molto forti e primi risultati lì che ci danno la fiducia che abbiamo un vero vincitore in questa particolare area chiamata recidiva convulsiva.

E infine, durante quest'anno, primo trimestre 2020, riveleremo anche ulteriori approfondimenti su padsevonil, che, riteniamo, affronterà un'importante area di pazienti refrattari dove c'è anche un alto bisogno insoddisfatto. Quindi, quando pensiamo alla nostra posizione epilettica oggi, abbiamo un portafoglio forte che sta generando per noi opzioni e soluzioni per molti pazienti in un ampio spettro. Oltre a una posizione molto forte a livello geografico, di cui parlerò tra poco, dove vedremo anche le basi della nostra crescita in tutte le nostre aree geografiche chiave. E quindi, con questa posizione abbiamo, essendo un leader di fiducia, una base molto solida che abbiamo in eredità e nelle nostre offerte future, siamo molto fiduciosi di essere in grado di continuare ad alimentare la crescita nel breve a medio termine dal nostro franchise di epilessia.

Quindi, se passiamo un po 'di tempo ad andare su Vimpat, che è uno dei nostri driver di crescita chiave, voglio esprimere 3 motivi per cui sono molto fiducioso di poter continuare a vedere questo bel percorso di crescita per Vimpat nel breve termine. Prima di tutto, il profilo di Vimpat è molto ampio in termini di mono e componente aggiuntivo. Oggi è davvero la scelta più affidabile per molti medici. Hanno un – vediamo un'ampia prescrizione per un gran numero di medici. Quindi è davvero il loro primo passo per il trattamento nella fase iniziale ed è davvero un marchio di fiducia basato sul suo profilo tollerabile molto favorevole. E chiaramente, ovviamente, anche l'efficacia che offre.

Il secondo motivo per cui siamo fiduciosi è quando pensiamo al nostro motore attraverso le nostre diverse aree geografiche, vedi che sul lato destro, abbiamo un'ampia posizione di presenza in tutte le aree geografiche con i nostri numeri di pazienti illustrati lì. E vediamo ancora una volta una crescita molto forte in tutte le nostre regioni e siamo molto chiari su come realizzare tale crescita con una base molto forte. Prevalentemente, la nostra crescita è guidata dal volume con un certo prezzo, ma riteniamo che sia una delle basi per una crescita continua. Il fatto che possiamo generare una nuova crescita attraverso nuovi volumi e nuovi pazienti con le nostre offerte che abbiamo oggi. E infine, la terza ragione di questa continua crescita è la gestione del ciclo di vita che vediamo l'espansione in nuove aree geografiche, Giappone, Cina e anche nuove indicazioni che abbiamo elencato lì per quanto riguarda le comunicazioni che avremo nella prima metà del 2020 .

Quindi, sono quindi molto fiducioso in questa fase con ciò che abbiamo nelle nostre mani per poter continuare a vedere questa crescita andare avanti. Pertanto, siamo molto fiduciosi di poter aumentare il picco delle vendite da 1,4 a 1,5 miliardi di EUR in base alle nostre attuali prove. Quindi, se poi concludessimo sull'epilessia. E solo per darti una conclusione molto rapida, ancora una volta, vediamo che questo è il 50% oggi delle nostre vendite nette di UCB. E abbiamo un track record di crescita molto forte, come vedi lì, del 14% o su base costante, del 10%, ed è molto guidato dai nostri marchi leader di Vimpat e Briviact. E quelle 2 offerte continuano a mostrare una crescita molto forte mentre le vediamo a medio termine. E continueremo a vedere l'esecuzione di ciascuno di quelli in tutte le aree geografiche che producono quella crescita che desideriamo nel breve termine di una crescita da singola a doppia cifra almeno elevata.

Ma come hai sentito anche da Emmanuel, oggi abbiamo il 50% delle nostre attività in epilessia, ma vediamo anche la nostra posizione diversificarsi a medio termine con, naturalmente, l'ulteriore crescita in Cimzia, il lancio di Bimab e anche la nostra posizione nella neuroinfiammazione con i lanci in arrivo su rozimab e Ra Pharma, quindi quei 7 lanci di cui hai sentito parlare Jean-Christophe, diversificheranno molto la nostra posizione nel medio termine. Ma a breve termine, siamo molto fiduciosi sulla crescita che possiamo offrire e contribuire dal franchise di epilessia.

Quindi, con ciò, vorrei fare alcune osservazioni su rozimab. E ancora, qui, come ho accennato nelle mie osservazioni introduttive, questo è il nuovo – o diciamo, il futuro vettore di crescita per noi nella neuroinfiammazione. È una risorsa chiara che vediamo come un potenziale per affrontare un gran numero di popolazioni di pazienti. Abbiamo iniziato lo sviluppo in 3 di questi, come vedi lì. E – ma crediamo che ci sia potenziale per ulteriori popolazioni di pazienti che potrebbero essere affrontate con rozimab sulla base di un'ampia piattaforma che abbiamo di malattie mediate da IgG. A completare questa è la nostra seconda modalità, che è l'acquisizione di Ra Pharma che ci darà una molecola diversa, non un anticorpo monoclonale, ma un peptide che avrà un diverso modo di erogazione e anche un diverso modo di agire per integrare l'inibizione. E quando metti insieme questi 2, ci sentiamo molto fiduciosi quando guardiamo alla nostra piattaforma che abbiamo su rozimab e Ra Pharma che possiamo diversificare la nostra impronta neurologica e la nostra posizione in malattie rare in aree ad alto bisogno insoddisfatto e anche dove c'è competizione più bassa.

E solo per darti un senso di rozimab, chiaramente, siamo concentrati sullo sviluppo in una vasta gamma di pazienti. Ma vediamo, certamente, nel mercato della plasmaferesi, che è oggi, un'area in cui la maggior parte dei pazienti sta ricevendo il loro trattamento che vi è un alto bisogno insoddisfatto lì. Preferenze del paziente per modi alternativi di consegnare potenzialmente sottocutaneo nel luogo in cui scelgono, e vediamo rozimab all'altezza delle loro promesse e in grado di rivolgersi a quel mercato, che oggi è stimato intorno a 11 miliardi di euro in plasmaferesi. Quindi una forte potenziale opportunità per noi in futuro lì.

E infine, vorrei concludere su Ra Pharma, solo per dire alcune parole su Ra Pharma. Come avresti saputo da noi prima quando abbiamo firmato l'accordo, vediamo una motivazione molto forte per questa acquisizione. Ci sentiamo componenti importanti per noi nella nostra crescita a lungo termine in urologia. Innanzitutto, colma una lacuna molto chiara nel darci il potenziale di condurre nella miastenia grave con un'opzione che consente ai pazienti di essere trattati in una fase più di mantenimento o in una fase controllata con zilucoplan, e vediamo che anche molto ben integrato con rozimab nelle fasi in cui le esigenze dei pazienti sono più in una fase refrattaria, dove hanno bisogno di un trattamento più intermittente. E vediamo che queste 2 opzioni forniscono davvero molte soluzioni ai pazienti per poter trattare la miastenia grave nel modo più efficace per il futuro.

In secondo luogo, con, come ho accennato in precedenza, il franchising e la piattaforma rozimab insieme a Ra Pharma, ci offre 2 modalità di malattie rare e ci dà davvero l'opportunità di espanderci in nuove popolazioni di pazienti che non siamo stati in grado di trattare prima. E la terza componente importante di questo accordo è che ci fornisce una piattaforma scientifica molto forte. Siamo molto soddisfatti delle fondamenta scientifiche di Ra Pharma e davvero la capacità della piattaforma di peptidi macrociclici di essere un potenziale motore di scoperta per noi, sarà anche un elemento importante di questo accordo. E infine, ci consente un'impronta strategica più forte nel nostro spazio di Boston Healthcare, che è un'ambizione importante che dobbiamo anche essere presenti in quell'importante spazio negli Stati Uniti.

Quindi, prima di passare a Detlef, concluderò di nuovo e ti lascerò con i 3 messaggi importanti sul perché siamo molto fiduciosi sul nostro franchising di neurologia: in primo luogo, l'epilessia rimane una crescita fondamentale molto forte. Siamo molto fiduciosi riguardo alla nostra posizione di leadership fidata in molte aree geografiche per essere in grado di garantire una crescita sostenuta nel breve termine; in secondo luogo, la neuroinfiammazione con rozimab e anche l'acquisizione di Ra Pharma ci danno una posizione molto forte per ampliare le nostre popolazioni di pazienti in malattie rare; and finally, our longer-term position with our strong scientific base in neurodegeneration and with the tau — anti-tau molecule going into confirmatory stage, we believe, we also have a strong position in neurodegeneration in the mid- to long term.

So with that, I'm going to hand over to Detlef to take us through some of the financial positions.

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Detlef Thielgen, UCB SA – Executive VP, CFO & Corporate Development (6)

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Thank you, Charl. I have to say that the financials are very good despite that a bit boring when you compare it to what Charl and Emmanuel were able to display in terms of what we are doing at the moment, but what we can do also in the future. Let me lead you to — through the main topics here, just for completeness. We achieved revenues of more than EUR 4.9 billion, as promised earlier this year, which is 6% growth, 7% on a constant base. So very nice and mainly driven by core products. And when you saw the presentations, I think, you got a sense of this and got a sense of the strong growth that we have been experiencing and that also have led to a very strong year finish.

When you look at the operating expenses, it is not a surprise in the situation that we are in with launching, with preparing launches but also having a broad pipeline in Phase III, that our expenses are going up. We have 10% more R&D expenses within our guidance. We have 15% increase in marketing and selling, which makes sense in terms of what you've heard of the launches and also the impact that these launches had. And we have taken the opportunity of a good year also to invest in all the growth pockets that we could see to really take advantage of our strong offerings. That has left us still with a very positive rEBITDA, recurring EBITDA, of 29.1%, which is slightly above the corridor and slightly above what we have guided. And it is over proportionally on the constant rate, which is the more telling variable here.

When you look to profit, one thing that might have surprised you a bit was the tax rate. This is also very easy to explain. We have been talking to you about our tech strategy and being prepared to take advantage of the different patent boxes, R&D credits and with a bit of luck of tax reforms like they happened in the U.K. and Switzerland this year. And that is exactly what has happened. And with more profit, more opportunities of these tax opportunities come in. That is why, as these incentives were given also by the different countries to spur innovation. Core earnings per share then are more or less a result of that, over proportional growth, same like profits, with EUR 5.2 per share.

I'd like to bridge to really 2020 with 2 slides. The first one is about the growth that we have been experiencing consistently over the years, and Jean-Christophe has referred to it, so I will make only one point on that. We have been telling you that we will have to invest more. We have invested more, but we have also managed well, and therefore, have been able, despite increasing R&D and despite increasing sales and marketing, to still keep the — our rEBITDA percentages high.

The next slide is more about investing in through the right things. And what we have been trying to tell you is that we are very conscious about that we have to reallocate the moneys to the right things. And when you look to the left side of the graph, then you see that cost of goods have been going down. R&D has been going down until 2 years ago, when we start into the preparation of our acceleration and expand phase with this broad pipeline that you see today and marketing and selling is more or less 1 year later where we are taking advantage of these products now coming to market. And you have seen the launches in that year.

So when you see G&A, we see no peaks there because we are getting more and more efficient and with more sales, this can also be achieved. So we want to leave you with this impression, I hope that you anyway have, that we are managing towards impact, and this is a good investment for the future. On the right side of the graph, it is something to be celebrated, at least, internally. We have reached net cash this year after long, long years of being in net debt position. We'll change that quickly with the expected Ra acquisition, a substantial part of that firepower that is created out of that is going away, but there is a bit of firepower left that can be used for the right things. Also here, investment into the right things and preparing yourself so that you can do that by real good reallocation.

Leaves me with the midterm guidance and the 2020 guidance. Let's start with 2020. Before we forget that this does not include the Ra Pharma acquisition, as we have not closed on it, this would not be opportune. So the revenue that we are foreseeing is EUR 5.05 billion to EUR 5.15 billion. It has continued strong core product growth, which you might not feel all the time when you look to the number, but there is more than these core products. There's established brands, there's supply in terms of manufacturing for the divested products, there's divested products, and there's also Keppra that is starting to erode more. So don't let yourself be tricked into — this would not be ambitious. This is a good guidance with the parameters that I just offered.

In terms of our rEBITDA, we're expecting 28% to 29% of revenue. When you have in mind that we are close to 26% today, in 2019, we're now thinking that it will be 28%, plus/minus 1% for R&D in the coming year, which already explains to you that we are making still good progress on the reallocation and keeping the profitability. Core EPS is a resulting number more or less out of this, and we are expecting EUR 4.80 to EUR 5.20. The tax ratio should be staying somewhat around the mid-teens for next year. And I would also encourage you to see this as a good number, a good range for your mid-term models, there will be fluctuations up and down. But when you want to model, this would be not bad to do, which brings me to the midterm guidance. rEBITDA revenue ratio of 31% will be 2021. Don't forget, we said it will move to 2022 when Ra will be closed, but we have given these numbers without Ra. Therefore, we are also moving back for this time.

Peak sales will be more or less the same for Briviact and Neupro, and Charl and Emmanuel were already talking about Cimzia being at the level of more than EUR 2 billion and Vimpat at the level of more than EUR 1.5 billion as peak sales.

With that, I would like to conclude, leave you with the feeling and hopefully, also your impression that these are very strong numbers and that we have delivered in the different things that we did want to deliver and hand over back to Jean-Christophe.

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Jean-Christophe Tellier, UCB SA – CEO & Executive Director (7)

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Thank you, Detlef. So we are now at the end of this presentation. I hope you have seen through the different presentations from Charl, Emmanuel and Detlef, the strong results in '19, and also the confidence in the future. The future starts tomorrow, and you see here for 2020, the different trigger points that we have. It will be a rich year in terms of continuation of acceleration of the pipeline, with the various step for rozanolixizumab, bimekizumab and padsevonil. You see also here the closing of Ra Pharma at Q1, the submission of bimekizumab in psoriasis at the midyear, as Emmanuel mentioned. And also, another Phase III starting in lupus with dapirolizumab in first half of the year. And our anti-tau UCB0107 Phase III that will start in Q2 that we have not mentioned yet. So you see strong year, good performance delivered, confidence in the future.

This year, a continuation of the acceleration of the pipeline and important trigger point as we continue to strengthen our future. You know that our plan is to launch up to 7 products by 2025. This notion of 6 or 7 is, of course, linked also to the acquisition and the closing of Ra Pharma, that's the reason of the 6. We have already 2 launches done with Evenity and Nazolam. This will help us to fulfill our missions to deliver sustainable patient value for the patient that you can see here as an example, (Anikere), Christophe, Wendy, Victoria, Lloyd and Kelly and so many others, who aspire to live the life that they want, which is also our aspiration to be able to deliver that for them.

And with that, this closes the session, and I would like to open now for the — for your questions. And just before opening to the questions, I would like to let you know that Iris have also joined us and will be available to answer your questions.

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Antje Witte, UCB SA – VP of IR (8)

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Thank you very much, Jean-Christophe. Qayyum, if you can start the question-and-answer session, please.

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Questions and Answers

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Operator (1)

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(Operator Instructions) We already have a question from Peter Verdult from Citi.

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Peter Verdult, Citigroup Inc, Research Division – Director (2)

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Peter Verdult, Citi. Three questions, please. For Detlef or Emmanuel, just on understanding the profitability flow-through to UCB on Evenity, especially in light of the drug sales ramp far exceeding expectations. You booked roughly about $10 million of other operating income on $150 million-odd of sales. So look, just the drug is on track to do more than $500 million. I mean, our back of the envelope calculations implies that that could flow through to at least $100 million of other operating income coming through. I realize you're not going to talk exact numbers, but anything you're willing to share and help us just better understand sort of the flow-through on profitability there would be very helpful.

Moving to the pipeline for Charl, JC or Iris, padsevonil data coming out next month, I believe. I think historically, this drug has been positioned as treatment-refractory epilepsy. When we speak to the docs, the profile that sort of was hinted at, as the Phase IIa comes through without any big issues with cognitive disorder. The message we're getting is that this could be a sort of add-on of choice or second add-on of choice. So I just want to understand from a UCB positioning, is padsevonil a sort of Briviact sort of niche product? Or could this blue sky be a sort of (impact) replacement?

And then lastly, Detlef, it's sad to think this might be the last time we hear your dulcet tones on the conference call, you've built a good reputation over the years guiding conservatively at the start of the year and always coming up with higher EBITDA and a tax rate way below guidance by the end of the year. Is it safe to assume with your successor yet to be announced that the spirit in which you've approached giving the guidance for 2020 is particularly conservative this year?

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (3)

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Peter, Emmanuel here. I'll start with answering the Evenity question and invite Detlef to jump in. So our partnership with Amgen is a 50-50 profit split partnership. And we have a partner in Japan, namely, Astellas, and so the costs and the rewards that go to Astellas for the piece of work they do is subtracted from the profit pool before we share it. So that's what I can tell you at this point. And in terms of future, of course, it will depend on the ramp-up as well. And the price point for this agent is different than for biologics in autoimmune, for example. So relatively, the COGS is a little higher than you would see with biologics. Detlef, anything to add here?

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Detlef Thielgen, UCB SA – Executive VP, CFO & Corporate Development (4)

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No, I think you made it perfectly clear.

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Jean-Christophe Tellier, UCB SA – CEO & Executive Director (5)

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So on padsevonil, maybe…

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (6)

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I can start and…

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Jean-Christophe Tellier, UCB SA – CEO & Executive Director (7)

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You can start and then…

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (8)

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Sì. So thank you, Peter, for your questions as well. The inclusion of criteria for padsevonil is really in refractory today. And we see, as I showed in my slides, 25% to 30% of patients are in this refractory segment where there's a high unmet need. So that will be our core initial positioning. I think we will learn more as we understand the data over the next months, if there is a potential broader usage. But certainly, today, we see it strongly in the refractory space where there is a very high unmet need. So Iris please add, if you would like as well?

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Iris Löw-Friedrich, UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices and Executive VP (9)

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No, there's not much to add. Peter, as you remember, padsevonil combines 2 of the most potent mechanisms of action in epilepsy, synaptic vesicle blockage plus a GABA-A receptor interaction. So it's only natural that we have selected those patients who are in most need for the initial treatment opportunity with padsevonil. You might also remember that the International League Against Epilepsy defines patients who have tried more than 2 antiepileptics and have no satisfactory treatment response as drug resistant, and we are enrolling in our clinical studies patients who have tried at a minimum 4 antiepileptic medicines and still are not controlled. So we are really, in the clinical trial, studying a highly drug refractory patient population. And that, in combination with a very potent mechanism of action, should give us unique outcomes that have not been demonstrated before. We will see results before the end of this quarter, and that will give us a basis for a discussion in a data-driven way, and that's the next big step.

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Jean-Christophe Tellier, UCB SA – CEO & Executive Director (10)

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Thank you, Iris. And Peter, if I may say, you have asked your questions about the spirit of the guidance in a very elegant way. And so Detlef, I will be curious to hear what is your perspective on it.

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Detlef Thielgen, UCB SA – Executive VP, CFO & Corporate Development (11)

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Peter, thank you very much for your perspective. I appreciate that. I have approached the guidance more or less, as always. So not a lot of change. As you know, we are giving, in this guidance, the benefit of taking the risk on FX rates. We are taking the risk on very volatile interest rates and therefore, we are approaching it with what we believe (in this guidance) can be delivered. For sure, and our track record shows that, the company has always delivered. And I would expect also that we will deliver this guidance. And if things are a good one, as well as we saw that in 2019, which was a bit better than we were expecting, otherwise, we would not have had to do the financial guidance update, then possibilities.

However, we are in an investment phase. And that also means that — I mentioned that before that we try to take any opportunity that we have throughout the year also to reinvest. So in that regard, I feel, to date, very comfortable that this is a guidance that we can achieve as we have achieved the others. And that our product portfolio is strong, therefore, we hope to have a bit of opportunity to reallocate in opportunities when they are coming.

I mentioned before, just — perhaps it might have been lost, that the top line, I read in some of your comments and it's very understandable, from (technical difficulty) looks a bit cautious. But when you think that we probably have to see each for Keppra established brands, the other revenues, royalty lines and divestments, an impact of roughly, let's say, around 1%, then I think (that's what I) mentioned. Then you are — I think it was quoted 2.5% to 4.5% is moving up to something that looks much more in line with what you would expect from our core products. So in that regard, no, I'm very happy to also leave a guidance that can be achieved, but that is also not one that isn't given under oath.

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Operator (12)

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We have another question from Richard Parkes from Deutsche Bank.

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Richard J. Parkes, Deutsche Bank AG, Research Division – Director (13)

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Let me have a few questions. And I'd also like to say best of luck to Detlef and I certainly don't remember you missing the guidance in 13, 14 years, I've been following the stock. It's been very helpful. So my question, firstly on Evenity performance. I'm just wondering if you could talk about to what degree we're seeing a bolus of sales in the most severe patients. Can you talk about how new patient starts have continued to evolve since the launch? So that's the first one.

Secondly, on the anti-tau antibody. Obviously, there's other drugs that have failed in PSP. I wondered if you could talk about how your compound compares and what evidence you have on brain penetration and target engagement based on the data you've seen so far? And I know you were looking at partnering in Alzheimer's disease and just wondered if that was still ongoing.

Third question is on bimekizumab. Obviously, we'll see the Phase III data at AAD, but — and you've outlined where you see the points of differentiation. But could you talk about, based on the data you've seen internally, does that continue to support your optimism of demonstrating superiority to Cosentyx on PASI 100?

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (14)

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So Richard, Emmanuel here. I'll take your 2 questions, and my answers might be a bit disappointing. But on the first one, Evenity, I'll have to guide you to Amgen. We've agreed with them that the commentary on the markets that they are (territory leasing) is going to be for them to make. And obviously, you're right to ask the question. It's a 12-month treatment. So we will need to renew the patients very regularly, and that's why we're investing across the world in ensuring that more patients are seen and are treated.

In terms of bimekizumab, I'm afraid we have to wait for the AAD detailed results.

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Iris Löw-Friedrich, UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices and Executive VP (15)

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Richard, this is Iris, and I would like to respond to you to your question regarding our tau antibody and our confidence for efficacy in PSP. And you mentioned the failures of competitor developmental assets. So as you know, the pathology in PSP are tau-tangles and we have designed our tau antibody in biological experiments with human material. And we have learned from these experiments that addressing a central epitope results in different efficacy in terms of preventing the spread than when you address peripheral epitopes. And the 2 molecules that you mentioned that just announced phased clinical studies are addressing peripheral epitopes, while our antibody is addressing a central epitope. So if you talk to our researchers, it was expected to see that failure in other molecules, and it's kind of a validation of our approach. Of course, we still have to demonstrate that the blockage of the central epitope will be efficacious.

You also asked about target engagement, and please rest assured that we have almost complete target engagement at the doses that we are taking into our confirmatory study. And I think while we all agree, this is, of course, a high-risk program, we have confidence in our data that has led us to go from Phase I directly into a single confirmatory trial. So based on everything that we have seen so far, we believe we have an antibody that holds high potential of being efficacious in this patient population who are very desperate and actually confronted with a death verdict when they get their diagnosis.

I would like to leave the question on Alzheimer's partnering to Charl, if I may.

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (16)

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Sì. Thank you, Iris. And actually, yes, we will continue to look at partnering in Alzheimer's. But our primary focus, as Iris had stated also, is in really the development in PSP where we see the primary value of this asset. And that's where we will focus. However, broadening the opportunity with a partnership would be something that we continue to talk to different possible interested parties as well. Va bene?

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Operator (17)

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Next question comes from Trung Huynh from Crédit Suisse.

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Trung Chuong Huynh, Crédit Suisse AG, Research Division – Research Analyst (18)

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I have 2 product ones and one modeling question. So firstly, on padsevonil, can you clarify the definition of refractory on Slide 16. In that chart, you show 25% of people living with epilepsy are refractory. Is this segment of patients that have failed 4-plus antiepileptics? And when it comes to labeling, will you try and get a label for refractory patients or given both your late-stage trials are in 4-plus failures, would this be the population?

Secondly, I might be reading too much into this, but the zilucoplan myasthenia gravis data, that's posted as 1H '21, you previously said the data should be expected early '21. Is there a slight delay there?

And then finally, to Detlef, thank you very much for your help over the years. I appreciate you're leaving, but can you help me one last time on your midterm cost levers, given we're 1 year closer to your 31% margin target. So on COGS, is there any opportunity for gross margin improvement here? You did 80% to 82% in 2 years. Does 82% represent a ceiling before your patent expiries? On SG&A, can you help with the growth of your marketing spend as you launch Evenity and (bime)? And then finally, on R&D. Thanks for the 28% ratio for 2020. But as we move forward, you're going to have higher marketing. What sort of R&D growth should we see, given you expect to have margin leverage going forward?

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Jean-Christophe Tellier, UCB SA – CEO & Executive Director (19)

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Va bene. So thank you for your question. On — so I'll start with padsevonil. So as Iris had mentioned earlier on the call, refractory definition is really failure on 2 antiepileptic drugs. In this case, for padsevonil, we are setting a very high hurdle of efficacy with inclusion criteria for patients that have failed on 4 antiepileptic drugs. So clearly, our label today and our intended label will be very much focused on refractory. We see that as essentially 1/3 of the market, of patients that are still — have a high unmet need. And so our focus there will be to position padsevonil on the initial label to treat these refractory population. And then I think your second question on Ra Pharma and the timing. This is consistent with what Ra Pharma has publicly stated. So we have not changed that position in terms of readout of zilucoplan.

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Detlef Thielgen, UCB SA – Executive VP, CFO & Corporate Development (20)

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So then back to the modeling. I think you got it right, both on the cost of goods and G&A, we have still a little bit to go, which it's just also the composition of the portfolio. However, I have to say, and it's not a surprise that our R&D expenses in the next 1 to 2 years will still go up, which leaves us then also, leaves us also understanding why we shifted the year from '21 to '22 because this potentially additional, let's say, 2% to 3% in R&D that is coming on top of what we need for our own late-stage pipeline could not be compensated. And that would then also bring it down a bit in the years in between.

However, the marketing and selling, there is a ramp-up that is crystal clear that we are seeing — have seen already now. We will see that going into the next 1 to 2 years for the key products. But we are also starting to see some opportunity with the overall product portfolio to reallocate. And that will take some of the edge-out of this. So we are comfortable on the 31%, whether it's '21 or '22, depending on without or with Ra Pharma. And I think I have the feeling, we'll make it again.

By the way, for the ones that already did that, thanks all the very kind words. I will keep them with me and have them in mind, always a pleasure.

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Operator (21)

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Our next question comes from Wimal Kapadia from Bernstein.

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Wimal Kapadia, Sanford C. Bernstein & Co., LLC., Research Division – Research Analyst (22)

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Wimal Kapadia from Bernstein. Just following up again on padsevonil. How much importance should we actually place on the Phase II data ahead of the Phase III next year, just given that the trial design size actually looks quite similar. Is there any possibility of filing on Phase IIb data just given the high unmet medical need? And just tied to that, you're clearly going after refractory population. Is it fair to assume high share, high price, because I think it's around 10% of epilepsy patients actually have failed for antiepileptics. So could we assume a relatively high share in that population?

And my second question is just on the upcoming — well, in 2 years' time the Vimpat genericization. Just to get a sense of whether we should really be using Keppra as a good benchmark. Given that it was a true gold standard at a larger installed base, was approved across multiple indications, so is it actually a good benchmark for how to model Vimpat genericizations? Or should we expect the decline to be somewhat faster?

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Iris Löw-Friedrich, UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices and Executive VP (23)

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Sì. Thank you very much. I'll start with your padsevonil, and you're absolutely right. But the Phase IIb study that will read out towards the end of this quarter is a very substantial study, 500 patients across different doses of padsevonil versus placebo. And the study is indeed quite similar to the Phase III study, similar patient population, fewer doses that we are testing in that study. So it's 2 adequate and well-controlled clinical trials. It is very clear that regulatory authority will insist on 2 of these studies to accept submission. Our very early proof-of-concept study, you might remember, was very small, just 50 patients, so that would not qualify in the eyes of the regulators as an adequate and well controlled study. And so we are very clear that we will need both studies for an acceptable filing to the regulators. I have a lot of empathy for your statement that the unmet medical need might lead us to believe differently, but we know very clear from agency feedback that that's not the case.

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (24)

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Perfect. And just to follow on to that. At this point, I think it's a little early to comment on price until we learn more about the profile, which we will certainly evaluate over the next months as we go forward.

Then onto your second question on the, how would you model the LOE of Vimpat? There is obviously some differences. Keppra had a lower competition at the stage of when it went off patent. Today, we see with Vimpat and the environment that we face with increased cost containment that you would probably see a slightly higher erosion of Vimpat than of Keppra. So that's how we would give you that guidance at this point.

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Operator (25)

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We have another question from Richard Vosser from JPMorgan.

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Richard Vosser, JP Morgan Chase & Co, Research Division – Senior Analyst (26)

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A few questions, please. Firstly, just thinking about your 31% guidance in 2021, which is the same as last year. You have upgraded the Cimzia guidance, and the Vimpat guidance since then has clearly more sales. I obviously understand that there is things to invest in, but they sound relatively limited in terms of R&D, and you'll be finishing some trials. So just a question why that 31% margin, why the need to clarify Ra Pharma into 2022, why that hasn't actually gone up? So that's the first question.

Second question, and apologies if this has already been batted back. But I think I heard that Evenity in Europe, where you will be in charge of the marketing, you might be able to comment on. So perhaps you could give us an idea of the opportunity you think there for 2020 and also a few years out. And then the final question is on hedging losses within the sales line. Just could you give us an idea of the hedging, maybe plans for 2020 and how to think about it. Clearly, there's not much of a currency benefit in 2020 at current rates. So we should be expecting lower losses, perhaps. So just some thoughts there and more detailed thoughts there.

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Detlef Thielgen, UCB SA – Executive VP, CFO & Corporate Development (27)

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I can take the 2 questions that are more financial in nature. There is this trick. When you look at absolute numbers, and they are rising and you keep the percentage equal that you are tricked into believing the absolute number is also equal but this is rising with it. So that is the first part of it. But the more important part is, it's a very fair point to say it is this overall going up, there should be more money and that is coming down. On the other hand, we also know much more than before in terms of what we have to do. We have additional clinical studies that we are starting that might not have been involved before. But we are feeling that we can compensate that by the improving top line and the profits that are coming by that. So it has not gotten easier due to the success of the portfolio but we are compensating by what I would believe good management and increasing top line.

On the FX, I think you're absolutely right. The FX at this moment is a little better than what we saw end of the year and what we saw throughout 2019. So at this point in time, from a hedging perspective, we are running slightly ahead of the game. However, this will be very marginal when — if it would stay this way. So I would not focus on that. We'll take that throughout the year, seeing what fluctuations will be there and if there's something that can be added, we will add it, as usual.

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (28)

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And Richard, on Evenity in Europe. As you know, access and pricing and reimbursement needs to be obtained in Europe. And so for 2020, the only sizable market to which we will have full access to is Germany. Now Germany is also the most underdeveloped bone builder market in Europe. So my guidance would say that contribution this year will be rather incremental in comparison with Japan and the U.S. and over time, of course, Evenity has significant potential in Europe, but it is something that will take a number of years to play out to an extent that would be really significant in light of a much more developed Japanese market and a U.S. market with different characteristics.

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Operator (29)

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Next question comes from Peter Welford from Jefferies.

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Peter James Welford, Jefferies LLC, Research Division – Senior Equity Analyst & European Pharmaceuticals Analyst (30)

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Just a few questions. Firstly, with regards to roza, looking on ClinicalTrials.gov, it looks as though there are now 2 ITP studies. I don't know if this is just a sort of error in the website. But I'm just curious, it does look as though you've also slightly delayed the ITP readout timeline relative to prior expectations. So just comment at all as what's going on there?

And secondly, then just on bimekizumab, I'm curious whether or not in HS — HS, sorry, did you consider doing the head-to-head versus HUMIRA? And if not, why not, I guess, given, obviously, you've done that in other indications, and it would seem like perhaps an obvious choice, given that they're obviously only approved therapy, you could then be the clear winner.

Thirdly, then looking at the Evenity, going back to Europe, I wonder if you can comment at all, presumably, you had some initial thoughts already on Germany with regards to price. If you could give us any sort of insights there, that will be much appreciated.

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Iris Löw-Friedrich, UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices and Executive VP (31)

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So Peter, on rozanolixizumab in ITP, I want to confirm that one Phase III study has started, and that's so far our plan. So I will go back to ClinicalTrials.gov and see what ambiguity there might be, but the confirmation is one study in ITP.

And to your question about data readout as it just has started, I'm not sure that we have given any date already…

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Antje Witte, UCB SA – VP of IR (32)

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Second half 2022.

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Iris Löw-Friedrich, UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices and Executive VP (33)

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'23.

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Antje Witte, UCB SA – VP of IR (34)

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'22. Second half, '22.

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Iris Löw-Friedrich, UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices and Executive VP (35)

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Second half 2022.

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (36)

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And on bimekizumab, thank you for your question. So there's actually several factors here. The first one is that we aim to reach the market rapidly. And quite a few patients in our proof-of-concept study would not be included because they had been exposed to HUMIRA. So we've decided to let those patients in because this will probably represent the state of the field by the time we get there. The second reason is that we actually included a HUMIRA reference arm in the proof-of-concept study, which was reported recently in a conference.

And so we were quite encouraged by the potential for a deeper response on certain endpoints with bimekizumab, which is not unlike what's been seen in other indications. So seeing 75% or 90% symptom reduction score DLQI01, and we believe that getting to the market rapidly with an asset that has a significant level of — a rate of deep responders is going to be sufficient in such an area of unmet need to gain access and to be successful commercially.

In terms of Evenity, the way it works in Germany is you are launching at the list price and then within a year or so, you have your AMNOG price. And so I don't really wish to comment on the list price to start with because it's not really going to be meaningful long term.

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Operator (37)

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Next question comes from Charles Pitman from Redburn.

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Charles Pitman, Redburn (Europe) Limited, Research Division – Biopharmaceutical Sell Side Research Analyst (38)

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Charles Pitman from Redburn. Firstly, if we assume the BE RADIANT study shows bimekizumab with superior efficacy to Cosentyx, what would be the hurdle to achieving standard of care status in psoriasis? And in that case, would you need to partner to commercialize it? And could peak sales grow to be larger than Cimzia in the long term?

Secondly, could you just help us with any color on initial physician uptake of Nazolam.

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (39)

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So Charles, thank you for your question on BE RADIANT. Sì. I mean, clearly, the reason why we've picked Cosentyx as a comparator is that it is a drug with a high market share and it's the most used of the IL-17A inhibitors. So at a very minimum, the asset would then be regarded as a superior option to what has almost become a standard of care in the field. Would we need to partner bimekizumab? I think the advantage we have with our focused entry with (Xeljanz) psoriasis is that we've established a capability in psoriasis, which we can easily scale across the U.S., Europe and Japan. We have a lot of experience also in terms of the clinical development and medical affairs angle, and I believe that our access capabilities, in particular, in the U.S. are strong now. As you've seen also from the increased Xeljanz) results and (guidance. So I wouldn't say that that should be a base case scenario at all.

And then you had another question related to — sorry…

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Jean-Christophe Tellier, UCB SA – CEO & Executive Director (40)

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Peak sales.

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (41)

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Peak sales, yes, it's way too early. But thanks for asking.

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (42)

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And Charles, to your question on Nazolam. So it's a little early to get a new prescription data as yet, given that we launched just recently essentially 2 months ago. But I can give you just a couple of points. Estimated patients in the U.S. that have a risk of seizure relapse is around 120,000 patients. We have today an estimate of around 1,000 patients in the first 2 months. What's driving a lot of the early success is unrestricted access. Between 40% and 50% of our accounts have unrestricted access, and we see that trending upward very quickly. So a very promising start and it's obviously, first-in-class and the broad adoption that we see within the community is very promising. But too early to really give you a clear read yet on the peak view of this, okay?

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Operator (43)

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Next question comes from Sandra Cauwenberghs from KBC Securities.

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Sandra Cauwenberghs, KBC Securities NV, Research Division – Director Research for Biotech and Pharma (44)

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First, my sincere congrats to the whole team for the nice progress that you made in 2019. I still have 3 small questions left. First on bimekizumab. So you will start a Phase III trial for a fourth indication? And this is still in the skin inflammation space, so I was wondering if outside of dermatology and rheumatology, do you see any additional benefit of this drug in other inflammatory areas? Or will you stay focused for now on these 2 segments in inflammation?

The second question is on zilucoplan. So you've mentioned earlier the plasma fractionation market or the apheresis market. Can you elaborate a little bit on the potential positioning of this drug. And will you limit yourself potentially to these orphan disease indications? Or do you see broader applications?

And then the last one is with regard to Neupro. So I think this is already on the market since about 14 years. Do you still see an interest in continuing to pursue this particular market?

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (45)

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Thank you, Sandra, and thank you for your question. On bimekizumab, we intend to focus indeed on rheumatology and dermatology indications. And with the strong position of Cimzia in spondylarthritis as well as RA, and our entry in psoriasis, I think we'll be in a good position to make the most of bimekizumab's impact for patients.

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (46)

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To your question on zilucoplan and the positioning. So typically, what our learning is of the MG patient today is that they start on normal steroids. And then as they lose control, they would go into a situation where they need other interventions. We see zilucoplan being very much the follow-on from steroids to a stage where they need greater control and that we see rozimab playing a strong role where there is periods where they are out of control or in refractory or exacerbations where they would need to have rozimab. And in that space, where we talk about rozimab is really where patients are today on IVIG, and that's the opportunity that we see to potentially provide alternative solutions for patients, and the preference for patients there, at least from our learnings, is to have a subcutaneous infusion at the place where they would like to have that at home or in the office. So we see the 2, zilucoplan and rozimab, coexisting very nicely on that continuum of care for patients with MG.

Then your second question on Neupro. So today, the treatment modality for Parkinson's really mostly symptomatic to address the motor symptoms. We are clearly in our future view of neurodegeneration, want to address potential of disease modification. So our science and our focus on research is really in that area of really trying to intervene earlier to have a better outcome for patients. And that's where we will continue to focus in that space.

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Operator (47)

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Next question comes from Jean-Jacques Le Fur from Bryan Garnier.

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Jean-Jacques Le Fur, Bryan Garnier & Co Ltd, Research Division – Analyst (48)

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A quick one on Cimzia and the peak sales. You mentioned EUR 2 billion regularly during your comments. But it's still just EUR 300 million more than you achieved last year. And last year, you already achieved 3 — close to EUR 300 million more in just 1 year. So isn't it a bit conservative to have this EUR 2 billion as a peak sales? Or is it fair to assume you have some chances, even great chances to beat this EUR 2 billion peak sales, let's say, by 2024, 2026?

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (49)

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Thank you, Jean-Jacques. So between '19 and '18, we had cash growth of a little more than EUR 200 million. Now the FX rate played a part in, not a predominant part, but at least 20%. And so this can always reverse, of course. So that's one thing to bear in mind. The second one is that, whilst we are growing in the number of segments, we're also decelerating in some others. And so it's really in those areas that we're differentiated that we're going to grow and so all of that should more than make up for the difference by EUR 300 million. So I think that — with that, the FX rate, we're offering you something that we're confident we can achieve, and that should also be meaningful enough for you to significantly update your models.

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Operator (50)

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Our next question comes from Emily Field from Barclays.

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Emily Field, Barclays Bank PLC, Research Division – Research Analyst (51)

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So at the beginning of the year, there was a lot of enthusiasm around the Momenta M254 hypersialyzed IVIg (sic) (Momenta M254 Hyper-Sialylated IVIg) proof-of-concept data in ITP, and thereby, the effects that that could have to competition for FcRns and IVIg as well in ITP and CIDP. I was just wondering if you could make any comments on that data? Or perhaps, more generally, just on anything that you've seen in the indications outside of MG, which you've obviously spoken a lot about for rozanolixizumab.

And then just secondarily, also, just on the upgrade to the Cimzia peak sales guidance. Have you changed at all any of your assumptions in terms of what you would be seeing regarding the U.S. biosimilar landscape? Or is the sales increase really more predicated on just continuation of trends that you're seeing in Cimzia with sort of the same underlying base assumptions on how bio — HUMIRA biosimilars will play out or if anything has changed regarding those assumptions?

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (52)

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Va bene. So on the Momenta question you had, we don't comment on competition. At this point, I would just say that there's a high unmet need in the plasmapheresis space and so we welcome more innovations there for a large number of patients. So to this point, we would not like to comment on that particular question.

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Jean-Christophe Tellier, UCB SA – CEO & Executive Director (53)

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And Emily, thank you for the Cimzia question. It's a good question. (Are you similar) assumption as to the entry of adalimumab remains 2023. So the upgraded guidance is independent of this. So no change to our assumptions there.

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Operator (54)

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Our last question comes from Tom Murillo from Degroof Petercam.

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Tomas Murillo Rodriguez, Degroof Petercam Asset Management – Director (55)

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I have a couple just on bimekizumab and Cimzia. Could you maybe elaborate a bit on the synergies you see in terms of SG&A for both products? And what midterm impact should we expect although in terms of cannibalization potential between both products? That's my first question.

My second question is on the oral zilucoplan or extended release version of zilucoplan, when should we see that on clinical development?

And last question, in terms of design of your ITP trial versus your peer competitor, efgartigimod. Maybe could you elaborate a bit on the potential difference you see in terms of targeted population.

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (56)

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Thank you, Tomas. Perhaps to frame the question on potential synergies between bimekizumab and Cimzia, I should first clarify that there's going to be a more or less, at least 2 years gap between our entry in dermatology and rheumatology, if everything goes well. And we would probably expand our dermatology coverage to be able to successfully launch bimekizumab. So I wouldn't factor in too many synergies as far as the launch in psoriasis is concerned. Perhaps there can be some later when bimekizumab gets introduced in axSpA and PsA. But frankly, we haven't really looked into that in great detail, and I don't think it should be a driver. So hopefully, that answers your question in terms of the costs.

And then in terms of co-positioning, I think it's a little early. We first would like to look at the totality of our clinical results across indications before deciding how we might possibly co-position both agents. But of course, you know that Cimzia is associated with advantages for the women of childbearing age population, which are linked to its molecular structure and specific trials we have done, which are unlikely to be reproduced in the same way for bimekizumab. So that's giving you something. Thank you, Tomas.

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Charl Van Zyl, UCB SA – Executive VP of Neurology Solutions & Head of EU/International (57)

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And Tomas, to your question on oral zilucoplan. Obviously, we are very happy that the Ra Pharma organization has the ambition to develop an oral. And this is, obviously, will be a great choice for patients. But today, it's too early to really comment on that until we have joined forces after closing.

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Iris Löw-Friedrich, UCB SA – Chief Medical Officer, Head of Development & Medical Patient Value Practices and Executive VP (58)

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And Tomas, to your question about the ITP study design. I think it's a kind of classical study design. We are recruiting patients with confirmed ITP, who, despite standard of care have a low platelet count. And we believe that rozanolixizumab in this patient population will be able to unfold a sustainable treatment effect, meaning bringing their platelets above count of 50,000, which would be the threshold for reduced bleeding risk. So that's kind of in a nutshell the patient population that's being enrolled.

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Antje Witte, UCB SA – VP of IR (59)

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Va bene. Grazie. I would like to close this Q&A session with 2 questions from the web. The first one from (Alex Pope) from (inaudible). Do you have any proof-of-concept data in humans in any of the indications you are pursuing with bimekizumab that bimekizumab is clinically superior to other IL-17?

And the second question is from Alex (inaudible). I hope I pronounced that correct, from (inaudible). How will you fund Ra Pharma acquisition? What is your net leverage goal after the acquisition, kind of a mid-term to long-term goal?

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Emmanuel Caeymaex, UCB SA – Executive VP of Immunology Solutions & Head of US (60)

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So on bimekizumab, no, we don't have proof-of-concept studies in humans. So it's based on reading across and significant work with statistics and modeling.

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Detlef Thielgen, UCB SA – Executive VP, CFO & Corporate Development (61)

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So concerning the leverage, as we are net cash at this moment in time, if you are just taking EUR 2 billion, you're ending up somewhere at around 1.5x. When you are taking the guidance in consideration, there's — as I mentioned already last year, there's also some extraordinary cash-outs that we will have for our manufacturing and R&D footprint, probably more than EUR 600 million in the coming years. So that will add to it. And we still reserve the opportunity to do the one or other smaller topic. The general idea is to stay below 2x, which doesn't mean that, that has to be all of the time. In that phase that we have just in, and from a very long-term perspective, a 1:1 would be very nice. However, it always depends on the opportunities. And I think we have been showing that we are willing to go up to 3.5x, 4x if that is really needed, and we have a short-term opportunity to bring it back. And we have no problem to be cash positive for some time if we are not seeing the right opportunities. So somewhat in between, it will be. And the 2x is probably a good one to keep in mind as an overall wish that we would have.

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Antje Witte, UCB SA – VP of IR (62)

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So with this, we conclude today's call with a Q&A session. Thank you very much for your interesting questions and for your interactions. Looking forward to see you out there in London, Paris, Brussels, wherever we go in the next couple of months, and I hope you have a great day and a great afternoon. Thank you very much, indeed.

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Operator (63)

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Ladies and gentlemen, this concludes today's conference call. Thank you all for your participation. You may now disconnect.

Psorilax:Offerta |crema per la cura della psoriasi

0

Psorilax: prezzo, funziona, recensioni, opinioni, dove si compra

Il sondaggio sulla consegna di farmaci topici di Global Rx Dermatology fornisce informazioni chiave sul settore, compresi fatti e cifre molto utili e importanti, opinioni di esperti e gli ultimi sviluppi in tutto il mondo. Il rapporto sul mercato globale è un documento importante per ogni appassionato di mercato, decisore politico, investitore e giocatore. Il rapporto fornisce fluttuazioni del valore CAGR durante il periodo di previsione 2019-2026 per il mercato. I rapporti di mercato di Rx Dermatology Topical Drug Delivery forniscono dati su modelli e miglioramenti e indirizzano settori e materiali aziendali, limiti e avanzamenti. In questo rapporto, viene fornita un'analisi SWOT e un'analisi degli investimenti approfondite che prevedono opportunità imminenti per gli operatori del mercato di Rx Dermatology Topical Drug Delivery.

Il mercato globale della consegna di farmaci per dermatologia Rx globale dovrebbe raggiungere 40.646,26 milioni di USD entro il 2026 da 29.475,18 milioni di USD nel 2018, con un CAGR del 4,2% nel periodo di previsione dal 2019 al 2026.

Scarica PDF gratuito Copia di esempio del rapporto @ https://databridgemarketresearch.com/request-a-sample/?dbmr=global-rx-dermatology-topical-drug-delivery-market

Analisi competitiva:

Alcuni dei principali attori che operano in questo mercato sono Galderma Laboratories, LP, Hisamitsu Pharmaceutical Co., Inc., Pfizer Inc., LEO Pharma A / S, GlaxoSmithKline plc., ALLERGAN, Bayer AG, 3M, Bausch Health Companies Inc., The Lubrizol Corporation, Cipla Inc., Kaken Pharmaceutical Co., Ltd. tra gli altri.

I farmaci topici svolgono un ruolo importante nella terapia delle malattie dermatologiche. I farmaci per dermatologia topica incorniciano una grande percentuale di prodotti nel mercato dei farmaci. Questi prodotti sono fabbricati attraverso processi di produzione specializzati come riempimento di volume preciso, miscelazione su larga scala, riscaldamento e imballaggio.

La somministrazione topica di farmaci può essere effettuata nel corpo attraverso percorsi oftalmici, rettali, vaginali e cutanei come vie topiche. Nel settore della dermatologia, la pelle svolge un ruolo importante nella somministrazione di farmaci topici per il trattamento delle malattie della pelle nei pazienti. I preparati topici vengono applicati sulla pelle per effetti superficiali, locali o sistemici. Le formulazioni topiche includono ingredienti terapeuticamente attivi che aiutano a trattare le malattie della pelle nei pazienti.

Il rilascio topico di farmaci è uno dei modi più efficaci di rilascio di farmaci in quanto fornisce risultati terapeutici ottimali. A poco a poco, il sistema topico di consegna dei farmaci è diventato sempre più importante nell'industria farmaceutica. La risposta farmacologica, sia l'effetto terapeutico desiderato sia l'effetto indesiderato indesiderato di un farmaco dipendono dalla concentrazione del farmaco nel luogo di azione, che a sua volta dipende dalla forma di dosaggio e dall'entità dell'assorbimento del farmaco nel sito di azione. Nel settore della dermatologia, molecola di farmaco applicata sulla pelle che penetra principalmente attraverso il percorso intercellulare tortuoso e continuo. Questi prodotti sono disponibili in diverse forme come unguenti, creme, lozioni, gel e altri che hanno la capacità di essere assorbiti nel corpo e mostrano rispettivamente la risposta positiva nella guarigione della ferita.

Mercato globale di consegna di farmaci topici dermatologici per tipo di prodotto (semisolido, liquido, solido), applicazione (infezioni della pelle, dermatite, antiaging, acne, iperpigmentazione, rosacea, cancro della pelle, psoriasi, onicomicosi, altri), categoria (marchiato, generico ), Geografia (Nord America, Europa, Asia-Pacifico, Sud America, Medio Oriente e Africa) – Tendenze e previsioni del settore fino al 2026

Segmentazione: Mercato globale della consegna di farmaci per dermatologia Rx globale

Il mercato globale della consegna di farmaci topici dermatologici Rx è segmentato in base al tipo di prodotto, all'applicazione e alla categoria.

  • Sulla base del tipo di prodotto, il mercato è segmentato in solido, liquido e semisolido. Il solido è sottosegmentato in polvere e altri. Il liquido viene suddiviso in soluzione, emulsione, sospensione, lozione e altri. Semisolid è sottosegmentato in creme, gel, unguenti, pasta, altri.
    • Nel dicembre 2016, Pfizer Inc. ha ricevuto l'approvazione da parte della Food and Drug Administration (FDA) statunitense per il prodotto chiamato EUCRISATM (crisaborole) unguento al 2%. È un nuovo inibitore topico non steroideo della fosfodieterasi-4 (PDE-4). È usato per il trattamento della dermatite atopica da lieve a moderata (AD). Con questo lancio del prodotto l'azienda ha costruito un patrimonio nel settore dell'infiammazione e dell'immunologia.
  • Sulla base dell'applicazione, il mercato è segmentato in acne, dermatite, psoriasi, infezioni della pelle, antiaging, cancro della pelle, iperpigmentazione, onicomicosi, rosacea, altri.
    • Nel marzo 2017, Galderma Laboratories, L.P., produttori del marchio Cetaphil hanno lanciato sette nuovi prodotti per la cura della pelle del viso. Con questo lancio dei prodotti il ​​portafoglio Cetaphil dell'azienda è aumentato. La società ha ora un'ampia gamma di soluzioni specializzate per i pazienti con problemi di pelle, tra cui idratazione e altri.
  • Sulla base della categoria, il mercato è segmentato in generico e marchiato.
    • Nel febbraio 2016, Allergan plc ha ricevuto un'approvazione per il suo prodotto ACZONE (dapsone) Gel, 7,5% dalla Food and Drug Administration (FDA) degli Stati Uniti. Questo prodotto è un nuovo trattamento topico di prescrizione che è utile per il trattamento dell'acne nei pazienti di età pari o superiore a 12 anni. Il prodotto ha aiutato il paziente a trattare facilmente l'acne che alla fine ha contribuito ad aumentare le entrate.

Richiedi questo rapporto dal nostro esperto @ https://databridgemarketresearch.com/inquire-before-buying/?dbmr=global-rx-dermatology-topical-drug-delivery-market

Recenti sviluppi:

  • Nell'aprile 2016, Allergan plc ha acquisito Topokine Therapeutics, Inc. con un pagamento anticipato di 85,8 milioni di USD ed è stato idoneo a ricevere pietre miliari potenziali di sviluppo e commercializzazione fino a 260,0 milioni di USD.
  • Nel febbraio 2019, Kaken Pharmaceutical Co., Ltd. ha concluso un accordo di licenza e distribuzione esclusiva per la formulazione topica di onicomicosi nella Repubblica popolare cinese. Secondo l'accordo Kaken Pharmaceutical Co., Ltd., ha fornito il diritto esclusivo per lo sviluppo e la commercializzazione del Prodotto in RPC e questo ha portato a un'elevata generazione di entrate.
  • Nell'aprile 2019, The Lubrizol Corporation ha lanciato il suo nuovissimo modificatore di reologia 2 in 1 multifunzionale, polimero Carbopol Style 2.0. Il prodotto ha i benefici per la cura della pelle come l'aspetto liscio lucido, le texture uniche e altro. Con questo lancio è aumentato il portafoglio di prodotti dell'azienda che ha comportato una maggiore generazione di entrate.
  • Nell'agosto 2018, Cipla INC. Ha ricevuto l'approvazione finale per la nuova domanda abbreviata di farmaci (ANDA) per Diclofenac Sodium Topical Gel, 1% dalla Food and Drug Administration degli Stati Uniti (US FDA). Per questo motivo l'azienda ha aumentato il proprio portafoglio di prodotti e una forte posizione sul mercato, specialmente nel campo della dermatologia.
  • Nel novembre 2010, 3M ha rilanciato la linea Cavilon Professional Skin Care. Questo prodotto ha aiutato a prevenire danni alla pelle da umidità, attrito e traumi adesivi. Il portafoglio di prodotti dell'azienda è aumentato per quanto riguarda la dermatologia archiviata e quindi le entrate sanitarie.

Opportunità:

BASSA PENETRAZIONE BIOLOGICA:

I biologici sono i farmaci che sono fatti da proteine ​​animali o umane che hanno la capacità di trattare rispettivamente le malattie. Hanno la capacità di trattare il numero di malattie come la psoriasi, l'artrite psoriasica, altri tipi di artrite e malattie infiammatorie intestinali. A causa della bassa attività dei farmaci biologici nel trattamento di eventuali malattie del derma, i farmaci topici stanno superando il mercato a fini terapeutici e quindi la sua domanda è in aumento sul mercato.

AUMENTO DEL CONCORSO CHE GUIDA AD ALTI INVESTIMENTI IN R&S PER INNOVARE NUOVI PRODOTTI:

La malattia della pelle negli ultimi tempi è una delle principali malattie tra le persone per le quali sono disponibili trattamenti. Uno dei trattamenti avanzati è il sistema topico di rilascio del farmaco in cui la pelle svolge un ruolo importante poiché il farmaco viene applicato sulla pelle che ha la capacità di trattare le aree colpite. Numero di aziende ha preso l'iniziativa nel fornire alta qualità di prodotti o farmaci per il trattamento delle malattie della pelle. Ciò comporta il processo di innovazione nella ricerca farmaceutica. L'aumento del numero di malattie richiede un trattamento adeguato per il quale i farmaci topici svolgono attualmente un ruolo importante. Di conseguenza, molte aziende hanno aumentato le proprie strutture di ricerca e sviluppo al fine di fornire i farmaci che saranno ritenuti un fattore importante per guidare il mercato in futuro.

AUMENTO DI FUSIONI E ACQUISIZIONI:

Le industrie farmaceutiche probabilmente subiscono la maggior parte delle attività di fusione e acquisizione (M&A) rispetto a qualsiasi altra industria che coinvolge il numero di operazioni e la spesa in denaro. Questa attività è necessaria a causa dell'aumento dello sviluppo di un nuovo farmaco nell'industria farmaceutica. Ad esempio, a luglio 2018, Leo Pharma ha acquisito un'unità globale di dermatologia su prescrizione di Bayer AG (Germania) a un prezzo non divulgato. Lo scopo di questa acquisizione era di espandere il loro prodotto nei farmaci per la pelle. Leo Pharma sviluppa ulteriormente l'attività di dermatologia su prescrizione con questa acquisizione. L'aumento delle acquisizioni e delle fusioni aiuta le aziende a rafforzare i propri ricavi insieme a strutture di ricerca e sviluppo e produzione e questo ultimo aiuto nella crescita di un particolare mercato.

MERCATO EMERGENTE:

L'elevata accessibilità per i pazienti sta portando a maggiori investimenti da parte del settore privato. Molte aziende si stanno concentrando sull'intraprendere sviluppi strategici per aumentare la loro presenza nelle economie emergenti. Insieme a questo, l'invecchiamento della popolazione e l'aumento del reddito disponibile contribuiranno alla crescita del mercato. Il mercato di consegna di farmaci topici ha una grande opportunità in quanto questa piattaforma ha nuovi elementi che sono stati incorporati per il trattamento di malattie della pelle e delle mucose. Le condizioni della pelle stanno aumentando in tutto il mondo, che alla fine richiede un trattamento. Aumentare la consapevolezza delle malattie della pelle è anche un fattore che sta aiutando il mercato a crescere in futuro.

sfide:

EFFETTI COLLATERALI:

L'effetto collaterale dei farmaci si verifica nell'uomo a causa dell'uso a lungo termine dei farmaci. Ci sono alcuni effetti collaterali che possono verificarsi nel corpo del paziente dopo aver consumato farmaci topici. Ad esempio, il consumo a lungo termine di corticosteroidi può causare difetti alla nascita nel feto. I farmaci topici possono fornire un trattamento migliore ma a parte questo anche il prodotto ha effetti collaterali. Ciò accade a causa dell'uso eccessivo di trattamenti topici che aumentano il rischio di effetti collaterali sia cutanei che sistemici e quindi ostacolano la crescita del mercato.

RICHIAMO DEL PRODOTTO:

Negli ultimi anni, il numero di richiami di prodotti nel mercato topico della consegna di droghe è aumentato enormemente. Questi richiami di prodotti possono verificarsi a causa di inadempienza della conformità, come difetti di progettazione o di fabbricazione che possono essere negoziati con la sicurezza, l'efficacia e la purezza del farmaco o dei dispositivi di consegna del farmaco da parte di un'azienda produttrice di farmaci. Ad esempio, a luglio 2016, GlaxoSmithKline (Regno Unito) ha annunciato il richiamo dell'unguento Bactroban e della crema Bactroban a causa della presenza di contaminazione durante la produzione; queste formulazioni sono state usate localmente per le infezioni della pelle. Inoltre, a giugno 2016, il cerotto per emicrania di Teva Phamaceutical chiamato Zecuity è stato ricordato per aver riportato gravi ustioni e potenziali cicatrici permanenti. Il richiamo dei prodotti influisce sui ricavi dell'azienda e, in definitiva, sul mercato particolare.

Nota: se hai esigenze particolari, faccelo sapere e ti offriremo il rapporto come desideri.

Informazioni sulla ricerca di mercato di Data Bridge:

Data Bridge Market Research si è affermata come una società di ricerca e consulenza di mercato non convenzionale e neoterica con un livello di resilienza senza precedenti e approcci integrati. Siamo determinati a scoprire le migliori opportunità di mercato e promuovere informazioni efficienti per far prosperare il tuo business sul mercato. Data Bridge si impegna a fornire soluzioni adeguate alle complesse sfide aziendali e avvia un processo decisionale senza sforzo.

Contatto:

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Psorilax:commenti |crema lenitiva per psoriasi

0

Psorilax: prezzo, funziona, recensioni, opinioni, ingredienti

BRUXELLES, 20 febbraio 2020 / PRNewswire / – 7:00 (CET) – informazioni regolamentate – “data-reagente =” 12 “>BRUXELLES, 20 febbraio 2020 / PRNewswire / – 7:00 (CET) – informazioni regolamentate –

  • I ricavi hanno raggiunto € 4,9 miliardi (+ 6%, + 7% CER(1)) le vendite nette sono aumentate a 4,7 miliardi di euro (+ 6%)
  • Redditività sottostante (rEBITDA(2)) è stato di 1,4 miliardi di euro (+ 2%, + 11% CER) o del 29,1% delle entrate
  • Aggiornamento R&S: bimekizumab con tre risultati positivi di Fase 3 nella psoriasi e iniziato un nuovo programma di Fase 3 nell'idradenite suppurativa; Cimzia® con approvazioni in Cina e Giappone
  • Previsioni finanziarie per il 2020: le entrate dovrebbero raggiungere € 5,05 – 5,15 miliardi,
    REBITDA(2) 28 – 29% delle entrate, core EPS(3) di € 4,80 – 5,20 previsto
  • Nuova guida alle vendite di punta per Cimzia® 2,0 miliardi di euro entro il 2024 e per Vimpat® 1,5 miliardi di euro entro il 2022
  • Nuova composizione del comitato esecutivo di UCB nel 2020

Jean-Christophe Tellier, CEO UCB. “In base alla nostra promettente pipeline in fase avanzata e all'acquisizione di Ra Pharma in sospeso, potremmo potenzialmente lanciare fino a 7 prodotti entro il 2025 per creare valore per il paziente per popolazioni specifiche ora e in futuro. Inoltre, ci concentriamo su quattro aree di sostenibilità che sono fondamentali al nostro successo a lungo termine e al nostro contributo alla società. “” data -eagid = “21”> “Il 2019 è stato un anno di forte crescita e crescita. Pertanto, abbiamo aggiornato la guida alle vendite di punta per Cimzia® e Vimpat® e continuiamo ad accelerare i nostri investimenti in futuri fattori di crescita “, ha affermato Jean-Christophe Tellier, CEO UCB. “In base alla nostra promettente pipeline in fase avanzata e all'acquisizione di Ra Pharma in sospeso, potremmo potenzialmente lanciare fino a 7 prodotti entro il 2025 per creare valore per il paziente per popolazioni specifiche ora e in futuro. Inoltre, ci concentriamo su quattro aree di sostenibilità che sono fondamentali al nostro successo a lungo termine e al nostro contributo alla società “.

Il Consiglio di amministrazione di UCB propone un dividendo di € 1,24 per azione (lordo), + 2%.

Gennaio 2020, è iniziato lo studio di fase 3 su pazienti con trombocitopenia immunitaria (ITP), i primi risultati attesi sono attesi in H 2 2022. “data-reagid =” 29 “> In Gennaio 2020, è iniziato lo studio di fase 3 su pazienti con trombocitopenia immunitaria (ITP), i primi risultati attesi sono attesi in H 2 2022.

Maggio 2019. “data-reactionid =” 32 “> A dicembre è stato lanciato UCB Nayzilam® (midazolam) Spray nasale CIV, il primo e unico trattamento di salvataggio nasale per i gruppi epilettici negli Stati Uniti Nayzilam® spray nasale è stato approvato negli Stati Uniti a Maggio 2019.

Cina.
A dicembre, Cimzia® è stato approvato per il trattamento della psoriasi e dell'artrite psoriasica in Giappone. “data-reactionid =” 33 “>Immunologia
Nel mese di luglio, Cimzia® (certolizumab pegol) è stato approvato in associazione con metotrexato per il trattamento dell'artrite reumatoide attiva da moderata a grave in pazienti adulti in Cina.
A dicembre, Cimzia® è stato approvato per il trattamento della psoriasi e dell'artrite psoriasica in Giappone.

  • Nel mese di ottobre, lo studio BE VIVID, che valuta l'efficacia e la sicurezza di bimekizumab negli adulti con psoriasi a placche cronica da moderata a grave ha raggiunto tutti gli endpoint primari e secondari, compresa un'efficacia significativamente maggiore rispetto a ustekinumab.
  • A novembre, lo studio BE READY, che valuta l'efficacia e la sicurezza di bimekizumab rispetto al placebo negli adulti con psoriasi a placche cronica da moderata a grave, hanno incontrato tutti gli endpoint primari e secondari classificati.
  • A dicembre, lo studio SIA SICURO, a confronto bimekizumab per adalimumab per il trattamento di adulti con psoriasi a placche da moderata a grave, ha soddisfatto tutti gli endpoint secondari e classificati, ottenendo un'efficacia significativamente maggiore rispetto a adalimumab.
  • Giappone, gli Stati Uniti., Corea del Sud, Canada e Australia nonché nell'UE. “data -eagid =” 41 “>Evenity® (romosozumab) è ora approvato in Giappone, gli Stati Uniti., Corea del Sud, Canada e Australia così come nell'UE.

    In ottobre, a seguito della procedura di riesame, il comitato per i medicinali per uso umano (CHMP) dell'Agenzia europea per i medicinali (EMA) ha adottato un parere positivo raccomandando l'autorizzazione all'immissione in commercio.

    La storia continua

    Europa, Le vendite nette di Keppra® sono state influenzate da un adeguamento locale degli sconti una tantum nella prima metà del 2019 “data-reazioni” = “53”>Keppra® (Levetiracetam) per l'epilessia, ha riportato un fatturato netto di 770 milioni di euro, che riflette sia il marchio forte e affidabile che la maturità del prodotto. Negli Stati Uniti le vendite nette sono state influenzate dalla concorrenza generica. Nel Europa, Le vendite nette di Keppra® sono state influenzate da un adeguamento locale degli sconti una tantum nella prima metà del 2019

    Europa sono stati quasi compensati dalla buona crescita dei mercati internazionali. “data -eagid =” 55 “>Neupro® (Rotigotina), la patch per il morbo di Parkinson, ha mostrato una leggera riduzione delle vendite nette a 319 milioni di euro. Riduzioni minori negli Stati Uniti, dovute all'ambiente di mercato generico – e Europa sono stati quasi compensati da una buona crescita nei mercati internazionali.

    Germania e il supplemento di ferro Niferex® nel primo trimestre del 2019, e prima che le 'coperture designate riclassificate nelle vendite nette' fossero cresciute del + 13% (+ 9% CER). Questa crescita è stata trainata dalla continua forte performance positiva dei prodotti core di UCB.
    Le entrate e le commissioni delle royalties sono diminuite a € 78 milioni da € 92 milioni. Le altre entrate sono aumentate a € 155 milioni dopo € 128 milioni. “Data-reazioni =” 57 “> Nel 2019, entrate e vendite nette aumentato del 6% (+ 7% CER) a 4 913 milioni di euro e rispettivamente a 4 680 milioni di euro (+ 6%; + 7% CER). Le vendite nette prima delle “coperture designate riclassificate in vendite nette” sono aumentate dell'11% (+ 7% CER) a 4 784 milioni di euro. Aggiustato per cessioni nel 2018, principalmente “Innere Medizin” /Germania e il supplemento di ferro Niferex® nel primo trimestre del 2019, e prima che le 'coperture designate riclassificate nelle vendite nette' fossero cresciute del + 13% (+ 9% CER). Questa crescita è stata trainata dalla continua forte performance positiva dei prodotti core di UCB.
    Le entrate e le commissioni delle royalties sono diminuite a € 78 milioni da € 92 milioni. Gli altri ricavi sono aumentati a € 155 milioni dopo € 128 milioni.

    Europa e nella spondiloartrite assiale non radiografica attiva (nr-axSpA) negli Stati Uniti, nonché i preparativi per il lancio di Evenity® nel Europa, Spese di ricerca e sviluppo superiori del 10% di € & nbsp; 1 & nbsp; 272 & nbsp; milioni – trainate da maggiori investimenti in R & amp; D e risultanti in un rapporto di R & amp; D del 26% nel 2019 dopo il 25% nel 2018 e dell'8% in più in generale e amministrativo spese per € 195 milioni, principalmente in relazione al nuovo modello organizzativo implementato nel 2019. Gli altri ricavi operativi sono stati € 48 milioni dopo spese di € 24 milioni nel 2018. I ricavi sono composti da contributi agli investimenti, utili su cessioni , liberazione di accantonamenti e entrate derivanti dalla collaborazione con Amgen in relazione a Evenity®. Ciò ha comportato un rapporto spese operative (in relazione ai ricavi) del 51% dopo il 50% nel 2018. “data-reazioni” = “59”>Spese operative ha raggiunto 2 527 milioni di euro (+ 9%; + 6% CER) riflettendo un aumento del 15% delle spese di marketing e vendita di 1 108 milioni di euro – guidato dal lancio di Cimzia® nella psoriasi negli Stati Uniti e Europa e nella spondiloartrite assiale non radiografica attiva (nr-axSpA) negli Stati Uniti, nonché i preparativi per il lancio di Evenity® nel Europa, Il 10% in più di spese di ricerca e sviluppo di 1 272 milioni di euro – trainati da maggiori investimenti in ricerca e sviluppo e risultante in un rapporto di ricerca e sviluppo del 26% nel 2019 dopo il 25% nel 2018 e 8% in più di spese generali e amministrative di 195 milioni di euro, principalmente connessione con il nuovo modello organizzativo implementato nel 2019. Gli altri ricavi operativi sono stati pari a 48 milioni di euro dopo spese di 24 milioni di euro nel 2018. I proventi sono composti da contributi agli investimenti, utili da cessione, liberazione di accantonamenti e proventi derivanti dalla collaborazione con Amgen in relazione con uniformità®. Ciò ha comportato un rapporto spese operative (in relazione ai ricavi) del 51% dopo il 50% nel 2018.

    Sei anni consecutivi di crescita hanno sottolineato nel tempo le solide prestazioni di UCB. UCB è pronta ad accelerare ulteriormente e ad espandersi per soddisfare le sue ambizioni di valore per il paziente, potenzialmente lanciando sei o sette nuovi prodotti entro il 2025.

    Jean-Christophe Tellier, CEO di UCB “data -eagid =” 70 “>” Per supportare le nostre ambizioni, abbiamo evoluto la nostra organizzazione e i nostri modi di lavorare per assicurarci di diventare più agili e collaborare più trasversalmente all'interno della nostra organizzazione. Riteniamo che questa organizzazione evoluta aumenterà la nostra chiarezza operativa ed efficienza e ci preparerà per lanci incentrati sul valore per il paziente “, ha affermato Jean-Christophe Tellier, CEO di UCB

    Questa evoluzione si riflette nella nuova composizione del Comitato Esecutivo UCB che è diventato più piccolo, con ruoli più trasversali tra le imprese e le regioni e con una maggiore attenzione alle aree di attività principali dell'azienda.

    1o febbraio 2020 la nuova composizione del Comitato Esecutivo di UCB è la seguente: “data -eagid =” 72 “> Da 1o febbraio 2020 la nuova composizione del Comitato esecutivo di UCB è la seguente:

    • Jean-Christophe Tellier, Amministratore delegato
    • Emmanuel Caeymaex, Vicepresidente esecutivo per le soluzioni immunologiche e capo degli Stati Uniti
    • Jean-Luc Fleurial, Vicepresidente esecutivo e direttore delle risorse umane
    • Iris Löw-Friedrich, Vicepresidente esecutivo e Chief Medical Officer
    • Kirsten Lund-Jurgensen, Vicepresidente esecutivo, Soluzioni di approvvigionamento e tecnologia
    • Dhaval Patel, Vicepresidente esecutivo e Direttore scientifico
    • Bill Silbey, Vicepresidente esecutivo e consigliere generale
    • Detlef Thielgen, Vicepresidente esecutivo, Direttore finanziario e Sviluppo aziendale
    • Charl van Zyl, Executive Vice President Neurology Solutions e Head of EU / International

    Alexander Moscho, Pascale Richetta, Bharat Tewarie e Jeff Wren hanno lasciato il Comitato Esecutivo e UCB è molto grato per i loro contributi passati. Bill Silbey e Kirsten Lund-Jurgensen è entrato a far parte del Comitato esecutivo nel 2019.
    Inoltre, UCB ha annunciato in Luglio 2019 che il Chief Financial Officer dell'azienda, Detlef Thielgen, uscirà da UCB nel primo semestre 2020. È in corso la ricerca di un successore. “data -eagid =” 83 “>Alexander Moscho, Pascale Richetta, Bharat Tewarie e Jeff Wren hanno lasciato il Comitato Esecutivo e UCB è molto grato per i loro contributi passati. Bill Silbey e Kirsten Lund-Jurgensen è entrato a far parte del Comitato esecutivo nel 2019.
    Inoltre, UCB ha annunciato in Luglio 2019 che il Chief Financial Officer dell'azienda, Detlef Thielgen, uscirà da UCB nel primo semestre 2020. È in corso la ricerca di un successore.

    https://www.ucb.com/investors/UCB-Governance#book-CMP_B_55790“data -eagid =” 84 “> Ulteriori informazioni sul Comitato esecutivo di UCB sono disponibili sul sito Web di UCB: https://www.ucb.com/investors/UCB-Governance#book-CMP_B_55790

    http://www.ucb.com/investors/Download-center& nbsp; “data -eagid =” 85 “> Trova i rapporti finanziari FY sul sito Web UCB: http://www.ucb.com/investors/Download-center

    Oggi UCB ospiterà una teleconferenza / webcast video alle 08.00 (EST) / 13.00 (GMT) / 14.00 (CET).

    https://www.ucb.com/investors/UCB-financials/Full-year-financial-results“data -eagid =” 87 “> I dettagli sono disponibili su https://www.ucb.com/investors/UCB-financials/Full-year-financial-results

    Bruxelles, Belgio (www.ucb.com) è una società biofarmaceutica globale focalizzata sulla scoperta e lo sviluppo di farmaci e soluzioni innovativi per trasformare la vita delle persone che vivono con gravi malattie del sistema immunitario o del sistema nervoso centrale. Con oltre 7 persone in circa 40 paesi, la società ha generato ricavi per € 4,9 miliardi nel 2019. UCB è quotata su Euronext Bruxelles (simbolo: UCB). Seguiteci su Twitter: @UCB_news “data -eagid =” 88 “>Informazioni su UCB
    UCB, Bruxelles, Belgio (www.ucb.com) è una società biofarmaceutica globale focalizzata sulla scoperta e lo sviluppo di farmaci e soluzioni innovativi per trasformare la vita delle persone che vivono con gravi malattie del sistema immunitario o del sistema nervoso centrale. Con oltre 7 600 persone in circa 40 paesi, la società ha generato ricavi per € 4,9 miliardi nel 2019. UCB è quotata su Euronext Bruxelles (simbolo: UCB). Seguiteci su Twitter: @UCB_news

    Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

    UCB is providing this information, including forward-looking statements, only as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

    Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

    (1) CER = constant exchange rates

    (3) Core EPS = core earnings per share

    (4) Due to rounding, some financial data may not add up in the tables.

    (5) Due to rounding, some financial data may not add up in the tables.

    (6) rEBITDA = recurring Earnings Before Interest, Taxes, Depreciation and Amortization charges

    http://www.prnewswire.com/news-releases/ucb-full-year-report-2019-301007945.html” data-reactid=”111″>View original content:http://www.prnewswire.com/news-releases/ucb-full-year-report-2019-301007945.html

    SOURCE UCB

    Psorilax:Per i ragazzi |crema aloe psoriasi recensioni

    0

    Psorilax: prezzo, funziona, recensioni, opinioni, come si usa

    Pune, 20 febbraio 2020 (GLOBE NEWSWIRE) – Il globale Mercato della fecondazione in vitro (FIV) si prevede che le dimensioni raggiungeranno i 36,39 miliardi di USD entro il 2026, con un CAGR del 10,1% entro il 2026. Ciò è attribuibile ai crescenti casi di infertilità tra le persone in tutto il mondo. Questo è più comune nei maschi che nelle femmine. Il valore di mercato è stato di 16,89 miliardi di USD nel 2018. La fecondazione in vitro è un processo di fecondazione in cui lo sperma e le uova vengono recuperati come campione e combinati manualmente nei laboratori. Vari studi dimostrano che quasi mezzo milione di bambini sono nati da questo processo o da altri processi riproduttivi di aiuto. Tali fattori sono responsabili della crescita del mercato della fecondazione in vitro.

    Rapporto più recente di Fortune Business Insights ™, intitolato, “Dimensione del mercato della fecondazione in vitro (IVF), analisi delle quote e del settore, per tipo (IVF convenzionale e IVF con ICSI), per procedura (non donatore fresco, non donatore congelato, donatore fresco e donatore congelato), per fine Utente (ospedali e cliniche della fertilità) e previsioni regionali, 2019-2026 ” fornisce una panoramica a 360 gradi del mercato e dei suoi parametri. Questi includono fattori di crescita, restrizioni, sfide e opportunità. Il rapporto fornisce anche una segmentazione dettagliata del mercato con cifre di mercato come base e previsioni e anche i tassi di crescita annuali composti (CAGR). Oltre a ciò, il rapporto fornisce spunti interessanti sul mercato, sugli sviluppi chiave del settore e sulle altre tendenze del mercato della fecondazione in vitro. Il rapporto è disponibile per la vendita sul sito Web dell'azienda.


    Per ulteriori informazioni nell'analisi di questo rapporto, visitare: https://www.fortunebusinessinsights.com/in-vitro-fertilization-ivf-market-102189


    Adozione e pratica dello stile di vita sedentario per aggiungere slancio alla crescita del mercato

    Al giorno d'oggi, le persone sono più propense agli obiettivi di carriera piuttosto che alla pianificazione familiare, e quindi spesso tendono a optare per le gravidanze tardive. Il numero crescente di tali casi è un fattore trainante del mercato dei fertilizzanti in vitro, come menzionato in precedenza, poiché i casi complicati vengono spesso risolti optando per il trattamento della fecondazione in vitro. Ciò è più comune in nazioni come il Regno Unito, il Giappone e gli Stati Uniti. Inoltre, si prevede che l'aumento del numero di infertilità maschile aumenti l'adozione del trattamento per fecondazione in vitro e quindi acceleri la dimensione del mercato della fecondazione in vitro nei prossimi anni. Oltre a ciò, le politiche di rimborso sostenute dal governo e i programmi di sensibilizzazione stanno aiutando la crescita complessiva del mercato della fecondazione in vitro della regione.

    Gli analisti di Fortune Business Insights ™ hanno affermato che “le spese e i rischi elevati legati al processo di fecondazione in vitro (IVF) e all'iniezione intracitoplasmatica di spermatozoi (ICSI) possono causare ostacoli al reddito complessivo del mercato della fecondazione in vitro”. Tuttavia, fattori come l'aumento dei casi di obesità tra le persone, l'infertilità tra gli uomini, la pratica dello stile di vita sedentario e altri probabilmente creeranno opportunità di crescita redditizia del mercato della fecondazione in vitro nei prossimi anni.

    L'Europa domina il mercato con il numero massimo di casi di trattamento registrati

    L'Europa detiene una quota dominante sul mercato della fecondazione in vitro con un fatturato di 7,57 miliardi di USD generato nell'anno 2018. Ciò è attribuibile all'aumento della prevalenza dell'infertilità e alla crescente popolarità del trattamento per fecondazione in vitro nella regione. Dall'altro lato, il mercato del Nord America assisterà a una crescita costante a causa degli alti costi associati al trattamento ICSI e IVF. Secondo i dati FertilityIQ, 2017, negli Stati Uniti, la spesa media di un paziente sottoposto a un singolo ciclo di fecondazione in vitro è di 22.000 USD. Pertanto, i pazienti negli Stati Uniti viaggiano in altri paesi per il trattamento della fecondazione in vitro citando costi inferiori.


    Richiedi una copia di prova del rapporto di ricerca: https://www.fortunebusinessinsights.com/enquiry/request-sample-pdf/in-vitro-fertilization-ivf-market-102189


    Le aziende stanno investendo nella costruzione di nuovi centri di fertilità per la generazione di entrate

    Boston IVF, Pelargos IVF e Monash IVF stanno attualmente dominando il mercato. I produttori del mercato della fecondazione in vitro stanno sviluppando nuovi centri con un trattamento efficiente e di alta qualità in località remote per accelerare la propria generazione di entrate e lasciare il segno nella concorrenza sul mercato. Ciò alla fine accelererà la dimensione complessiva del mercato della fecondazione in vitro.

    Significativi sviluppi del settore nel mercato della fecondazione in vitro:

    Maggio 2019 – Gli scienziati di Monash IVF hanno sviluppato un nuovo test di screening dell'embrione per ridurre il rischio di aborto spontaneo al momento del trattamento della fecondazione in vitro.

    Luglio 2019 – L'apertura di un nuovo centro IVF a servizio completo presso l'ufficio Westshore di Tampa, in Florida, è stata annunciata da Shady Grove Fertility. L'obiettivo principale dietro l'apertura di questo centro è quello di offrire opzioni di trattamento della fertilità accessibili e di alta qualità alla popolazione regionale.

    Elenco delle principali società che operano nel mercato della fecondazione in vitro (FIV) includono:

    • Monash IVF
    • Fertilità Ovation
    • Centro IVF Bloom
    • Fertilità di Shady Grove
    • Centro IVF di Bangkok
    • Boston IVF
    • Pelargos IVF
    • RSMC
    • Clinica Group Ambroise Paré
    • Altri fornitori di servizi


    Hai qualche domanda? Chiedi ai nostri esperti: https://www.fortunebusinessinsights.com/enquiry/speak-to-analyst/in-vitro-fertilization-ivf-market-102189


    Tabella dei contenuti dettagliata:

    • introduzione
      • Ambito di ricerca
      • Segmentazione del mercato
      • Metodologia di ricerca
      • Definizioni e presupposti
    • Sintesi
    • Dinamica del mercato
      • Driver di mercato
      • Vincoli di mercato
      • Opportunità di mercato
    • Informazioni chiave
      • Prevalenza di infertilità, per paese / regione chiave, 2018
      • Numero di procedure IVF, per Paese / regioni chiave, 2018
      • Numero di cliniche di fertilità registrate, per paesi chiave, 2018
      • Scenario di rimborso, per Paese / regione chiave
      • Principali sviluppi del settore, partenariati, fusioni e acquisizioni
    • Analisi di mercato, approfondimenti e previsioni del mercato della fecondazione in vitro globale (IVF), 2015-2026
      • Risultati chiave / Riepilogo
      • Analisi di mercato, approfondimenti e previsioni – per tipo
        • FIV convenzionale
        • FIV con ICSI
      • Analisi di mercato, approfondimenti e previsioni – Per procedura
        • Non donatore fresco
        • Non donatore congelato
        • Donatore fresco
        • Donatore congelato
      • Analisi di mercato, approfondimenti e previsioni – Per utente finale
        • ospedali
        • Cliniche di fertilità
      • Analisi di mercato, approfondimenti e previsioni – Per regione
        • Nord America
        • Europa
        • Asia Pacifico
        • America latina
        • Medio Oriente e Africa

    TOC Continua ….


    Richiesta di personalizzazione: https://www.fortunebusinessinsights.com/enquiry/customization/in-vitro-fertilization-ivf-market-102189


    Dai un'occhiata ai rapporti correlati:

    Mercato della diagnostica in vitro (IVD) Dimensioni, condivisione e analisi del settore, per tipo di prodotto (strumenti, reagenti e materiali di consumo), per tecnica (immunodiagnostica, chimica clinica, diagnostica molecolare, punto di cura, ematologia e altri), per applicazione (malattie infettive, cardiologia, oncologia, gastroenterologia, Altri), per utente finale (laboratori clinici, ospedali, uffici medici, altri) e previsioni regionali, 2019-2026

    Mercato della tecnologia di riproduzione assistita (ART) Analisi delle dimensioni, della quota e del settore, per tecnica (fecondazione in vitro (IVF), fecondazione artificiale (AI-IUI), trasferimento di embrioni congelati (FET) e altri), per procedura (donatore fresco, non donatore fresco, donatore congelato e non donatori congelati), per utente finale (cliniche per la fertilità e ospedali) e previsioni regionali, 2019-2026

    Mercato dei biomarcatori Analisi delle dimensioni, della quota e del settore, per indicazione (oncologia, cardiologia, neurologia e altri), per utente finale (aziende farmaceutiche e biotecnologiche, laboratori di diagnostica e ricerca, ospedali e cliniche specializzate e altri) e previsioni regionali, 2019-2026

    Mercato dei dispositivi per neuroendoscopia Analisi delle dimensioni, della quota e dell'industria, per tipo di prodotto (neuroendoscopi rigidi, neuroendoscopi flessibili), per tipo di applicazione (neuroendoscopia transnasale, neuroendoscopia intraventricolare, neuroendoscopia transcranica), per utente finale (ospedali, cliniche specializzate, altri) e previsioni regionali, 2019-2026

    Mercato di sequenziamento di nuova generazione (NGS) Dimensioni, quote e analisi del settore per tipo (prodotti, strumenti e software, materiali di consumo, servizi), per applicazione (diagnostica, ricerca), per utente finale (istituti di ricerca, strutture sanitarie e centri diagnostici, società farmaceutiche e biotecnologiche, organizzazione di ricerca a contratto) E previsioni regionali, 2019-2026

    Mercato della medicina rigenerativa Dimensioni, quota e analisi del settore per prodotto (terapia cellulare, terapia genica, ingegneria tissutale, plasma ricco di piastrine), applicazione (ortopedia, cura delle ferite, oncologia), canale di distribuzione (ospedali, cliniche) e previsioni regionali, 2019-2026

    Mercato della genomica Dimensioni, condivisione e analisi del settore per tipo (prodotti, servizi), tecnologia (reazione a catena della polimerasi, sequenziamento di prossima generazione, microarray, sequenziamento di Sanger), applicazione (diagnostica, ricerca), utente finale (istituti di ricerca, strutture sanitarie e centri diagnostici , Aziende farmaceutiche e biotecnologiche, organizzazione di ricerca a contratto (CRO)) e previsioni regionali, 2019-2026

    Mercato dei servizi della Contract Research Organization (CRO) Analisi delle dimensioni, della quota e del settore per tipo di servizio (scoperta, pre-clinica, clinica, servizi di laboratorio), per applicazione (oncologia, cardiologia, malattie infettive, disturbi metabolici, altro), per utente finale (aziende farmaceutiche e biotecnologiche, società di dispositivi medici , Istituti accademici e di ricerca, altri) e previsioni regionali 2019-2026

    Mercato dell'immunologia Dimensione, quota e analisi del settore per classe di farmaci (anticorpo monoclonale (mAb), proteine ​​di fusione, immunosoppressori, anticorpi policlonali (pAb), altri), per indicazione di malattia (artrite reumatoide, artrite psoriasica, psoriasi a placche, spondilite anchilosante, malattia infiammatoria intestinale, Profilassi del rifiuto d'organo, altri), per canale distributivo e previsioni regionali 2019-2026

    Mercato immunodiagnostico Dimensioni, quota e analisi del settore per strumenti di prodotto, reagenti e materiali di consumo), per applicazione (oncologia ed endocrinologia, epatite e retrovirus, marker cardiaci, malattie infettive), per utente finale (laboratori clinici, ospedali, uffici medici), per utente finale (Ospedali, cliniche dentali, istituti accademici e di ricerca) e previsioni regionali, 2019-2026

    Mercato Ortobiologico Analisi delle dimensioni, della quota e del settore per tipo di prodotto (viscosupplementi, stimolatori della crescita ossea, matrice ossea demineralizzata, sostituti ossei sintetici, cellule staminali, allotrapianti), per applicazione (fusione spinale, maxillo-facciale e dentale, riparazione di tessuti molli, chirurgia ricostruttiva e di frattura), Per utente finale (ospedali, centri di chirurgia ambulatoriale, cliniche specializzate) e previsioni regionali 2019-2026


    Riguardo a noi:

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    I nostri report contengono un mix unico di intuizioni tangibili e analisi qualitative per aiutare le aziende a raggiungere una crescita sostenibile. Il nostro team di analisti e consulenti esperti utilizza strumenti e tecniche di ricerca leader del settore per compilare studi di mercato completi, intervallati da dati rilevanti.

    A Fortune Business Insights ™ miriamo a evidenziare le opportunità di crescita più redditizie per i nostri clienti. Pertanto, offriamo raccomandazioni, rendendo più semplice la navigazione tra i cambiamenti tecnologici e di mercato. I nostri servizi di consulenza sono progettati per aiutare le organizzazioni a identificare opportunità nascoste e comprendere le sfide competitive prevalenti.

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    Psorilax:Come sbarazzarsi di |psoriasi crema al cortisone

    0

    Psorilax: prezzo, funziona, recensioni, opinioni, originale

    In Vitro Fertilization (IVF) Market size is prophesized to reach USD 36.39 billion by 2026, with a CAGR 10.1% by 2026. This is attributable to the increasing cases of infertility among people worldwide. This is more common in males than female partners. The market value was USD 16.89 billion in 2018. IVF is a fertilization process wherein sperm and eggs are retrieved as a sample and are combined manually in laboratories. Various studies show that almost half a million babies are born by this process or other assistant reproductive processes. Such factors are responsible for the in vitro fertilization market growth.” data-reactid=”12″>Pune, Feb. 20, 2020 (GLOBE NEWSWIRE) — The global In Vitro Fertilization (IVF) Market size is prophesized to reach USD 36.39 billion by 2026, with a CAGR 10.1% by 2026. This is attributable to the increasing cases of infertility among people worldwide. This is more common in males than female partners. The market value was USD 16.89 billion in 2018. IVF is a fertilization process wherein sperm and eggs are retrieved as a sample and are combined manually in laboratories. Various studies show that almost half a million babies are born by this process or other assistant reproductive processes. Such factors are responsible for the in vitro fertilization market growth.

    Nowadays, people are more inclined towards career goals rather than family planning, and therefore often tend to opt for late pregnancies. The increasing number of such cases is a major in vitro fertilizer market driver, as mentioned earlier, since complicated cases are often resolved by opting for IVF treatment. This is more common in nations such as the UK, Japan, and the U.S. Besides this, the rise in the number of male infertility is anticipated to increase the adoption of IVF treatment and thus accelerate the in vitro fertilization market size in the coming years. Besides this, government-supported reimbursement policies and awareness programs are aiding the overall in vitro fertilization market growth of the region.

    Analysts at Fortune Business Insights™ said” high expenses and risks related to the in vitro fertilization process (IVF) and Intracytoplasmic sperm injection (ICSI) may cause hindrance to the overall in vitro fertilization market revenue”. Nevertheless, factors such as increasing obesity cases among people, infertility among men, the practice of sedentary lifestyle, and others are likely to create lucrative IVF market growth opportunities in the coming years.

    Europe holds a dominant in vitro fertilization market share with a revenue of USD 7.57 billion generated in the year 2018. This is attributable to the rise in the prevalence of infertility and the increasing popularity of IVF treatment in the region. On the other side, the market in North America will witness steady growth on account of the high cost associated with ICSI and IVF treatment. As per the FertilityIQ data, 2017, in the U.S., the average expenditure of a patient undergoing a single IVF cycle is USD 22,000. Thus, patients in the U.S are travelling to other countries for IVF treatment citing lower costs.

    Boston IVF, Pelargos IVF, and Monash IVF are currently dominating the market. In vitro fertilization market manufacturers are developing new centers with efficient and high-quality treatment in remote locations for speeding their own revenue generation and making their mark in the market competition. This will ultimately accelerate the overall IVF market size.

  • Monash IVF
  • Ovation Fertility
  • Bloom IVF Centre
  • Shady Grove Fertility
  • Bangkok IVF center
  • Boston IVF
  • Pelargos IVF
  • RSMC
  • Group Ambroise Paré Clinic
  • Other Service Providers
  • https://www.fortunebusinessinsights.com/enquiry/speak-to-analyst/in-vitro-fertilization-ivf-market-102189
    ” data-reactid=”43″>
    Have Any Query? Ask Our Experts: https://www.fortunebusinessinsights.com/enquiry/speak-to-analyst/in-vitro-fertilization-ivf-market-102189

  • Introduction
    • Research Scope
    • Market Segmentation
    • Research Methodology
    • Definitions and Assumptions
  • Executive Summary
  • Market Dynamics
    • Market Drivers
    • Market Restraints
    • Market Opportunities
  • Key Insights
    • Prevalence of Infertility, For Key Country/Region, 2018
    • Number of IVF Procedures, For Key Country/Regions, 2018
    • Number of Registered Fertility Clinics, For Key Countries, 2018
    • Reimbursement Scenario, For Key Country/Region
    • Key Industry Developments, Partnerships, Mergers and Acquisition
  • Global In Vitro Fertilization (IVF) Market Analysis, Insights and Forecast, 2015-2026
    • Key Findings / Summary
    • Market Analysis, Insights and Forecast – By Type
      • Conventional IVF
      • IVF with ICSI
    • Market Analysis, Insights and Forecast – By Procedure
      • Fresh Non-donor
      • Frozen Non-donor
      • Fresh Donor
      • Frozen Donor
    • Market Analysis, Insights and Forecast – By End User
      • Hospitals
      • Fertility Clinics
    • Market Analysis, Insights and Forecast – By Region
      • North America
      • Europe
      • Asia Pacific
      • Latin America
      • Middle East & Africa
  • TOC Continued….!
    ” data-reactid=”51″>TOC Continued….!

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    In-vitro Diagnostics (IVD) Market Size, Share & Industry Analysis, By Product Type (Instruments, Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Point of Care, Hematology and Others), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, Others), By End User (Clinical Laboratories, Hospitals, Physicians Offices, Others) and Regional Forecast, 2019 – 2026″ data-reactid=”54″>In-vitro Diagnostics (IVD) Market Size, Share & Industry Analysis, By Product Type (Instruments, Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Point of Care, Hematology and Others), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, Others), By End User (Clinical Laboratories, Hospitals, Physicians Offices, Others) and Regional Forecast, 2019 – 2026

    Assisted Reproductive Technology (ART) Market Size, Share & Industry Analysis, By Technique (In-Vitro Fertilization (IVF), Artificial Insemination (AI-IUI), Frozen Embryo Transfer (FET), and Others), By Procedure (Fresh Donor, Fresh Non-donor, Frozen Donor, and Frozen Non-donor), By End User (Fertility Clinics, and Hospitals) and Regional Forecast, 2019-2026″ data-reactid=”55″>Assisted Reproductive Technology (ART) Market Size, Share & Industry Analysis, By Technique (In-Vitro Fertilization (IVF), Artificial Insemination (AI-IUI), Frozen Embryo Transfer (FET), and Others), By Procedure (Fresh Donor, Fresh Non-donor, Frozen Donor, and Frozen Non-donor), By End User (Fertility Clinics, and Hospitals) and Regional Forecast, 2019-2026

    Biomarkers Market Size, Share & Industry Analysis, By Indication (Oncology, Cardiology, Neurology, and Others), By End User (Pharmaceutical & Biotechnology Companies, Diagnostics & Research Laboratories, Hospitals & Specialty Clinics, and Others), and Regional Forecast, 2019-2026″ data-reactid=”56″>Biomarkers Market Size, Share & Industry Analysis, By Indication (Oncology, Cardiology, Neurology, and Others), By End User (Pharmaceutical & Biotechnology Companies, Diagnostics & Research Laboratories, Hospitals & Specialty Clinics, and Others), and Regional Forecast, 2019-2026

    Neuroendoscopy Devices Market Size, Share & Industry Analysis, By Product Type (Rigid Neuroendoscopes, Flexible Neuroendoscopes), By Application Type (Transnasal Neuroendoscopy, Intraventricular Neuroendoscopy, Transcranial Neuroendoscopy), By End User (Hospitals, Specialty Clinics, Others) and Regional Forecast, 2019-2026″ data-reactid=”57″>Neuroendoscopy Devices Market Size, Share & Industry Analysis, By Product Type (Rigid Neuroendoscopes, Flexible Neuroendoscopes), By Application Type (Transnasal Neuroendoscopy, Intraventricular Neuroendoscopy, Transcranial Neuroendoscopy), By End User (Hospitals, Specialty Clinics, Others) and Regional Forecast, 2019-2026

    Next-Generation Sequencing (NGS) Market Size, Share and Industry Analysis By Type (Products, Instruments & Software, Consumables, Services), By Application (Diagnostics, Research), By End User (Research Institutes, Healthcare Facilities & Diagnostic Centres, Pharmaceutical & Biotechnological Companies, Contract Research Organization) & Regional Forecast, 2019 – 2026

    Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2019 – 2026″ data-reactid=”58″>Next-Generation Sequencing (NGS) Market Size, Share and Industry Analysis By Type (Products, Instruments & Software, Consumables, Services), By Application (Diagnostics, Research), By End User (Research Institutes, Healthcare Facilities & Diagnostic Centres, Pharmaceutical & Biotechnological Companies, Contract Research Organization) & Regional Forecast, 2019 – 2026

    Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2019 – 2026

    Genomics Market Size, Share and Industry Analysis By Type (Products, Services), Technology (Polymerase Chain Reaction, Next-generation Sequencing, Microarray, Sanger Sequencing), Application (Diagnostics, Research), End-User (Research Institutes, Healthcare Facilities & Diagnostic Centers, Pharmaceutical & Biotechnological Companies, Contract Research Organization (CROs)) & Regional Forecast, 2019 – 2026″ data-reactid=”59″>Genomics Market Size, Share and Industry Analysis By Type (Products, Services), Technology (Polymerase Chain Reaction, Next-generation Sequencing, Microarray, Sanger Sequencing), Application (Diagnostics, Research), End-User (Research Institutes, Healthcare Facilities & Diagnostic Centers, Pharmaceutical & Biotechnological Companies, Contract Research Organization (CROs)) & Regional Forecast, 2019 – 2026

    Contract Research Organization (CRO) Services Market Size, Share and Industry Analysis By Service Type (Discovery, Pre-Clinical, Clinical, Laboratory Services), By Application (Oncology, Cardiology, Infectious Disease, Metabolic Disorders, Others), By End User (Pharmaceutical & Biotechnological Companies, Medical Device Companies, Academic & Research Institutes, Others), and Regional Forecast 2019-2026″ data-reactid=”60″>Contract Research Organization (CRO) Services Market Size, Share and Industry Analysis By Service Type (Discovery, Pre-Clinical, Clinical, Laboratory Services), By Application (Oncology, Cardiology, Infectious Disease, Metabolic Disorders, Others), By End User (Pharmaceutical & Biotechnological Companies, Medical Device Companies, Academic & Research Institutes, Others), and Regional Forecast 2019-2026

    Immunology Market Size, Share and Industry Analysis By Drug Class (Monoclonal antibody (mAb), Fusion Proteins, Immunosuppressant, Polyclonal antibody (pAb), Others), By Disease Indication (Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Disease, Prophylaxis of Organ Rejection, Others), By Distribution Channel, and Regional Forecast 2019-2026″ data-reactid=”61″>Immunology Market Size, Share and Industry Analysis By Drug Class (Monoclonal antibody (mAb), Fusion Proteins, Immunosuppressant, Polyclonal antibody (pAb), Others), By Disease Indication (Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Disease, Prophylaxis of Organ Rejection, Others), By Distribution Channel, and Regional Forecast 2019-2026

    Immunodiagnostics Market Size, Share and Industry Analysis By Product Instruments, Reagents & Consumables), By Application (Oncology & Endocrinology, Hepatitis & Retrovirus, Cardiac Markers, Infectious Diseases), By End user (Clinical Laboratories, Hospitals, Physician’s Offices), By End-user(Hospitals, Dental Clinics, Academic & Research Institutes) and Regional Forecast, 2019 – 2026″ data-reactid=”62″>Immunodiagnostics Market Size, Share and Industry Analysis By Product Instruments, Reagents & Consumables), By Application (Oncology & Endocrinology, Hepatitis & Retrovirus, Cardiac Markers, Infectious Diseases), By End user (Clinical Laboratories, Hospitals, Physician’s Offices), By End-user(Hospitals, Dental Clinics, Academic & Research Institutes) and Regional Forecast, 2019 – 2026

    Orthobiologics Market Size, Share and Industry Analysis by Product Type (Viscosupplements, Bone Growth Stimulators, Demineralized Bone Matrix, Synthetic Bone Substitutes, Stem Cells, Allografts), By Application (Spinal Fusion, Maxillofacial & Dental, Soft Tissue Repair, Reconstructive & Fracture Surgery), By End User (Hospitals, Ambulatory Surgical Centers, Speciality Clinics), and Regional Forecast 2019-2026″ data-reactid=”63″>Orthobiologics Market Size, Share and Industry Analysis by Product Type (Viscosupplements, Bone Growth Stimulators, Demineralized Bone Matrix, Synthetic Bone Substitutes, Stem Cells, Allografts), By Application (Spinal Fusion, Maxillofacial & Dental, Soft Tissue Repair, Reconstructive & Fracture Surgery), By End User (Hospitals, Ambulatory Surgical Centers, Speciality Clinics), and Regional Forecast 2019-2026

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    https://www.fortunebusinessinsights.com/press-release/in-vitro-fertilization-ivf-market-9606
    ” data-reactid=”69″>Press Release: https://www.fortunebusinessinsights.com/press-release/in-vitro-fertilization-ivf-market-9606

    Psorilax:Prevenire |crema psoriasi genitale

    0

    Psorilax: prezzo, funziona, recensioni, opinioni, ingredienti

    Pune, 20 febbraio 2020 (GLOBE NEWSWIRE) – Il globale Mercato della fecondazione in vitro (FIV) si prevede che le dimensioni raggiungeranno i 36,39 miliardi di USD entro il 2026, con un CAGR del 10,1% entro il 2026. Ciò è attribuibile ai crescenti casi di infertilità tra le persone in tutto il mondo. Questo è più comune nei maschi che nelle femmine. Il valore di mercato è stato di 16,89 miliardi di USD nel 2018. La fecondazione in vitro è un processo di fecondazione in cui lo sperma e le uova vengono recuperati come campione e combinati manualmente nei laboratori. Vari studi dimostrano che quasi mezzo milione di bambini sono nati da questo processo o da altri processi riproduttivi di aiuto. Tali fattori sono responsabili della crescita del mercato della fecondazione in vitro.

    Rapporto più recente di Fortune Business Insights ™, intitolato, “Dimensioni del mercato della fecondazione in vitro (IVF), analisi delle quote e del settore, per tipo (IVF convenzionale e IVF con ICSI), per procedura (non donatore fresco, non donatore congelato, donatore fresco e donatore congelato), per fine Utente (ospedali e cliniche della fertilità) e previsioni regionali, 2019-2026 ” fornisce una panoramica a 360 gradi del mercato e dei suoi parametri. Questi includono fattori di crescita, restrizioni, sfide e opportunità. Il rapporto fornisce anche una segmentazione dettagliata del mercato con cifre di mercato come base e previsioni e anche i tassi di crescita annuali composti (CAGR). Oltre a ciò, il rapporto fornisce spunti interessanti sul mercato, sugli sviluppi chiave del settore e sulle altre tendenze del mercato della fecondazione in vitro. Il rapporto è disponibile per la vendita sul sito Web dell'azienda.


    Per ulteriori informazioni nell'analisi di questo rapporto, visitare: https://www.fortunebusinessinsights.com/in-vitro-fertilization-ivf-market-102189


    Adozione e pratica dello stile di vita sedentario per aggiungere slancio alla crescita del mercato

    Al giorno d'oggi, le persone sono più propense agli obiettivi di carriera piuttosto che alla pianificazione familiare, e quindi spesso tendono a optare per le gravidanze tardive. Il numero crescente di tali casi è un fattore trainante del mercato dei fertilizzanti in vitro, come menzionato in precedenza, poiché i casi complicati vengono spesso risolti optando per il trattamento della fecondazione in vitro. Ciò è più comune in nazioni come Regno Unito, Giappone e Stati Uniti. Inoltre, si prevede che l'aumento del numero di infertilità maschile aumenti l'adozione del trattamento per fecondazione in vitro e quindi acceleri la dimensione del mercato della fecondazione in vitro nei prossimi anni. Oltre a ciò, le politiche di rimborso sostenute dal governo e i programmi di sensibilizzazione stanno aiutando la crescita complessiva del mercato della fecondazione in vitro della regione.

    Gli analisti di Fortune Business Insights ™ hanno affermato che “le spese e i rischi elevati legati al processo di fecondazione in vitro (IVF) e all'iniezione intracitoplasmatica di spermatozoi (ICSI) possono causare ostacoli al reddito complessivo del mercato della fecondazione in vitro”. Tuttavia, fattori come l'aumento dei casi di obesità tra le persone, l'infertilità tra gli uomini, la pratica dello stile di vita sedentario e altri probabilmente creeranno opportunità di crescita redditizia del mercato della fecondazione in vitro nei prossimi anni.

    L'Europa domina il mercato con il numero massimo di casi di trattamento registrati

    L'Europa detiene una quota dominante sul mercato della fecondazione in vitro con un fatturato di 7,57 miliardi di USD generato nell'anno 2018. Ciò è attribuibile all'aumento della prevalenza dell'infertilità e alla crescente popolarità del trattamento della fecondazione in vitro nella regione. Dall'altro lato, il mercato del Nord America assisterà a una crescita costante a causa degli alti costi associati al trattamento ICSI e IVF. Secondo i dati FertilityIQ, 2017, negli Stati Uniti, la spesa media di un paziente sottoposto a un singolo ciclo di fecondazione in vitro è di 22.000 USD. Pertanto, i pazienti negli Stati Uniti viaggiano in altri paesi per il trattamento della fecondazione in vitro citando costi inferiori.


    Richiedi una copia di prova del rapporto di ricerca: https://www.fortunebusinessinsights.com/enquiry/request-sample-pdf/in-vitro-fertilization-ivf-market-102189


    Le aziende stanno investendo nella costruzione di nuovi centri di fertilità per la generazione di entrate

    Boston IVF, Pelargos IVF e Monash IVF stanno attualmente dominando il mercato. I produttori del mercato della fecondazione in vitro stanno sviluppando nuovi centri con un trattamento efficiente e di alta qualità in località remote per accelerare la propria generazione di entrate e lasciare il segno nella concorrenza sul mercato. Ciò alla fine accelererà la dimensione complessiva del mercato della fecondazione in vitro.

    Significativi sviluppi del settore nel mercato della fecondazione in vitro:

    Maggio 2019 – Gli scienziati di Monash IVF hanno sviluppato un nuovo test di screening dell'embrione per ridurre il rischio di aborto spontaneo al momento del trattamento della fecondazione in vitro.

    Luglio 2019 – L'apertura di un nuovo centro IVF a servizio completo presso l'ufficio Westshore di Tampa, in Florida, è stata annunciata da Shady Grove Fertility. L'obiettivo principale dietro l'apertura di questo centro è quello di offrire opzioni di trattamento della fertilità accessibili e di alta qualità alla popolazione regionale.

    Elenco delle principali società che operano nel mercato della fecondazione in vitro (FIV) includono:

    • Monash IVF
    • Fertilità Ovation
    • Centro IVF Bloom
    • Fertilità di Shady Grove
    • Centro IVF di Bangkok
    • Boston IVF
    • Pelargos IVF
    • RSMC
    • Clinica Group Ambroise Paré
    • Altri fornitori di servizi


    Hai qualche domanda? Chiedi ai nostri esperti: https://www.fortunebusinessinsights.com/enquiry/speak-to-analyst/in-vitro-fertilization-ivf-market-102189


    Tabella dei contenuti dettagliata:

    • introduzione
      • Ambito di ricerca
      • Segmentazione del mercato
      • Metodologia di ricerca
      • Definizioni e presupposti
    • Sintesi
    • Dinamica del mercato
      • Driver di mercato
      • Vincoli di mercato
      • Opportunità di mercato
    • Informazioni chiave
      • Prevalenza di infertilità, per paese / regione chiave, 2018
      • Numero di procedure IVF, per Paese / regioni chiave, 2018
      • Numero di cliniche di fertilità registrate, per paesi chiave, 2018
      • Scenario di rimborso, per Paese / regione chiave
      • Principali sviluppi del settore, partenariati, fusioni e acquisizioni
    • Analisi di mercato, approfondimenti e previsioni del mercato della fecondazione in vitro globale (IVF), 2015-2026
      • Risultati chiave / Riepilogo
      • Analisi di mercato, approfondimenti e previsioni – per tipo
        • FIV convenzionale
        • FIV con ICSI
      • Analisi di mercato, approfondimenti e previsioni – Per procedura
        • Non donatore fresco
        • Non donatore congelato
        • Donatore fresco
        • Donatore congelato
      • Analisi di mercato, approfondimenti e previsioni – Per utente finale
        • ospedali
        • Cliniche di fertilità
      • Analisi di mercato, approfondimenti e previsioni – Per regione
        • Nord America
        • Europa
        • Asia Pacifico
        • America latina
        • Medio Oriente e Africa

    TOC Continua ….


    Richiesta di personalizzazione: https://www.fortunebusinessinsights.com/enquiry/customization/in-vitro-fertilization-ivf-market-102189


    Dai un'occhiata ai rapporti correlati:

    Mercato della diagnostica in vitro (IVD) Dimensioni, condivisione e analisi del settore, per tipo di prodotto (strumenti, reagenti e materiali di consumo), per tecnica (immunodiagnostica, chimica clinica, diagnostica molecolare, punto di cura, ematologia e altri), per applicazione (malattie infettive, cardiologia, oncologia, gastroenterologia, Altri), per utente finale (laboratori clinici, ospedali, uffici medici, altri) e previsioni regionali, 2019-2026

    Mercato della tecnologia di riproduzione assistita (ART) Analisi delle dimensioni, della quota e del settore, per tecnica (fecondazione in vitro (IVF), fecondazione artificiale (AI-IUI), trasferimento di embrioni congelati (FET) e altri), per procedura (donatore fresco, non donatore fresco, donatore congelato e non donatori congelati), per utente finale (cliniche per la fertilità e ospedali) e previsioni regionali, 2019-2026

    Mercato dei biomarcatori Analisi delle dimensioni, della quota e del settore, per indicazione (oncologia, cardiologia, neurologia e altri), per utente finale (aziende farmaceutiche e biotecnologiche, laboratori di diagnostica e ricerca, ospedali e cliniche specializzate e altri) e previsioni regionali, 2019-2026

    Mercato dei dispositivi per neuroendoscopia Analisi delle dimensioni, della quota e dell'industria, per tipo di prodotto (neuroendoscopi rigidi, neuroendoscopi flessibili), per tipo di applicazione (neuroendoscopia transnasale, neuroendoscopia intraventricolare, neuroendoscopia transcranica), per utente finale (ospedali, cliniche specializzate, altri) e previsioni regionali, 2019-2026

    Mercato di sequenziamento di nuova generazione (NGS) Dimensioni, quote e analisi del settore per tipo (prodotti, strumenti e software, materiali di consumo, servizi), per applicazione (diagnostica, ricerca), per utente finale (istituti di ricerca, strutture sanitarie e centri diagnostici, società farmaceutiche e biotecnologiche, organizzazione di ricerca a contratto) E previsioni regionali, 2019-2026

    Mercato della medicina rigenerativa Dimensioni, quota e analisi del settore per prodotto (terapia cellulare, terapia genica, ingegneria tissutale, plasma ricco di piastrine), applicazione (ortopedia, cura delle ferite, oncologia), canale di distribuzione (ospedali, cliniche) e previsioni regionali, 2019-2026

    Mercato della genomica Dimensioni, condivisione e analisi del settore per tipo (prodotti, servizi), tecnologia (reazione a catena della polimerasi, sequenziamento di prossima generazione, microarray, sequenziamento di Sanger), applicazione (diagnostica, ricerca), utente finale (istituti di ricerca, strutture sanitarie e centri diagnostici , Aziende farmaceutiche e biotecnologiche, organizzazione di ricerca a contratto (CRO)) e previsioni regionali, 2019-2026

    Mercato dei servizi della Contract Research Organization (CRO) Dimensioni, quote e analisi del settore per tipo di servizio (scoperta, servizi preclinici, clinici, di laboratorio), per applicazione (oncologia, cardiologia, malattie infettive, disturbi metabolici, altro), per utente finale (aziende farmaceutiche e biotecnologiche, società di dispositivi medici , Istituti accademici e di ricerca, altri) e previsioni regionali 2019-2026

    Mercato dell'immunologia Dimensione, quota e analisi del settore per classe di farmaci (anticorpo monoclonale (mAb), proteine ​​di fusione, immunosoppressori, anticorpi policlonali (pAb), altri), per indicazione di malattia (artrite reumatoide, artrite psoriasica, psoriasi a placche, spondilite anchilosante, malattia infiammatoria intestinale, Profilassi del rifiuto d'organo, altri), per canale distributivo e previsioni regionali 2019-2026

    Mercato immunodiagnostico Dimensioni, quota e analisi del settore per strumenti di prodotto, reagenti e materiali di consumo), per applicazione (oncologia ed endocrinologia, epatite e retrovirus, marker cardiaci, malattie infettive), per utente finale (laboratori clinici, ospedali, uffici medici), per utente finale (Ospedali, cliniche dentali, istituti accademici e di ricerca) e previsioni regionali, 2019-2026

    Mercato Ortobiologico Analisi delle dimensioni, della quota e del settore per tipo di prodotto (viscosupplementi, stimolatori della crescita ossea, matrice ossea demineralizzata, sostituti ossei sintetici, cellule staminali, allotrapianti), per applicazione (fusione spinale, maxillo-facciale e dentale, riparazione di tessuti molli, chirurgia ricostruttiva e di frattura), Per utente finale (ospedali, centri di chirurgia ambulatoriale, cliniche specializzate) e previsioni regionali 2019-2026


    Riguardo a noi:

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    I nostri report contengono un mix unico di intuizioni tangibili e analisi qualitative per aiutare le aziende a raggiungere una crescita sostenibile. Il nostro team di analisti e consulenti esperti utilizza strumenti e tecniche di ricerca leader del settore per compilare studi di mercato completi, intervallati da dati rilevanti.

    A Fortune Business Insights ™ miriamo a evidenziare le opportunità di crescita più redditizie per i nostri clienti. Pertanto, offriamo raccomandazioni, rendendo più semplice la navigazione tra i cambiamenti tecnologici e di mercato. I nostri servizi di consulenza sono progettati per aiutare le organizzazioni a identificare opportunità nascoste e comprendere le sfide competitive prevalenti.

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    Comunicato stampa: https://www.fortunebusinessinsights.com/press-release/in-vitro-fertilization-ivf-market-9606

    Psorilax:Ristrutturato |novacell crema psoriasi

    0

    Psorilax: prezzo, funziona, recensioni, opinioni, dove si compra

    Statistica dell'artrite psoriasica: età in cui viene diagnosticata la PsA, PsA colpisce ugualmente uomini e donne, numero di persone con psoriasi che svilupperanno PsA, percentuale di pazienti con storia familiare di PsA, numero di anni che la PsA si sviluppa dopo la psoriasi
    Nikki Cagle
    I segni dell'artrite psoriasica comprendono dita e dita gonfie, dolore ai piedi, dolore lombare e psoriasi
    Nikki Cagle
    I trattamenti per l'artrite psoriasica comprendono FANS, inibitori del TNF, interleuchine, DMARD
    Nikki Cagle

    Esiste una dieta PsA?

    Non esiste una dieta specifica per la PsA. Tuttavia, si raccomanda che se si è in sovrappeso, una dieta a basso contenuto calorico può aiutare a sentirsi meglio. Si consiglia una dieta priva di glutine se si è dimostrato positivo alla sensibilità al glutine. La supplementazione di vitamina D può essere utile, ma sono necessarie ulteriori ricerche. Ci sono alimenti che sono noti per essere pro-infiammatori come quelli fritti e quelli con zucchero in eccesso, quindi potrebbe essere meglio evitarli (un buon consiglio per tutti).

    In che modo la PsA è diversa dalla RA?

    La maggior parte delle persone con artrite psoriasica avrà anche la psoriasi, che non è tipica dell'artrite reumatoide. L'artrite psoriasica di solito si manifesta in una sola articolazione, come un ginocchio, mentre la RA in genere colpisce entrambi. È simmetrico in questo modo. La dattilite, il gonfiore di un dito o del dito del piede, è anche più comune nella PsA rispetto all'AR. Non esiste un esame del sangue per PsA, ma se si dispone di RA, spesso può essere rilevato da analisi del sangue.

    Cosa fa scattare una riacutizzazione di PsA?

    Alcuni fattori scatenanti possono essere individuali, come perdere una buona notte di sonno o lavorare troppo duramente, ma uno universale è lo stress, o il tipo fisico che si verifica con un colpo al ginocchio o un virus o l'angoscia emotiva, come il tipo che accompagna un grande transizione di vita.

    Ci sono integratori che possono aiutare la PsA?

    Ci sono alcune ricerche promettenti sugli integratori di omega-3 e la vitamina D, ma sono necessari ulteriori studi, secondo la National Psoriasis Foundation. La glucosamina e la condroitina sono spesso propagandate come utili per l'artrite, ma tutti gli studi sono stati condotti sull'osteoartrite, non sull'artrite psoriasica. Verificare sempre con il proprio medico prima di assumere qualsiasi vitamina o integratore da banco, poiché potrebbe interagire con i farmaci Rx.