es and solutions that focus on engagement, health analytics and clinical services to improve the value of care delivered to patients. Product Approvals In 2015, the company announced that the Japanese Pharmaceuticals and Medical Devices Agency approved Marizev (omarigliptin) 25 mg and 12.5 mg tablets, an oral, once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for the treatment of adults with type 2 diabetes. Japan is the first country to have approved omarigliptin. Joint Ventures The company and Sanofi Pasteur S.A. formed a joint venture to market human vaccines in Europe and to collaborate in the development of combination vaccines for distribution in the then-existing European Union (EU) and the European Free Trade Association. Merck and Sanofi Pasteur contributed, among other things, their European vaccine businesses for equal shares in the joint venture, known as Sanofi Pasteur MSD, S.N.C.). The joint venture maintains a presence, directly or through affiliates or branches, in Belgium, Italy, Germany, Spain, France, Austria, Ireland, Sweden, Portugal, the Netherlands, Switzerland and the United Kingdom and through distributors in the rest of its territory. Licenses In 1998, a subsidiary of Schering-Plough Corporation (Schering-Plough) entered into a licensing agreement with Centocor Ortho Biotech Inc. (Centocor), a Johnson & Johnson (J&J) company, to market Remicade, which is prescribed for the treatment of inflammatory diseases. Research and Development For the Fiscal Year Ended December 31, 2015, the company’s research and development expenses were $6.7 billion. Research and Development Update The company has various candidates under regulatory review in the United States or internationally. Keytruda is an FDA-approved anti-PD-1 therapy in clinical development for expanded indications in different cancer types. Keytruda is approved for the treatment of melanoma, advanced melanoma and NSCLC. In 2015, the company announced that the FDA granted Breakthrough Therapy designation to Keytruda for the treatment of patients with microsatellite instability high metastatic colorectal cancer. Keytruda was previously granted Breakthrough Therapy status for advanced melanoma and advanced NSCLC. The Keytruda clinical development program consists of approximately 200 clinical trials, including approximately 100 trials that combine Keytruda with other cancer treatments. These studies encompass approximately 30 cancer types, including bladder, colorectal, esophageal, gastric, head and neck, melanoma, multiple myeloma, non-small-cell lung, and triple negative breast, various of which are in Phase 3 clinical development. MK-6072, bezlotoxumab, is an investigational antitoxin for the prevention of Clostridium difficile (C. difficile) infection recurrence under review with the FDA and EMA. In January 2016, the company announced that the FDA accepted for review the Biologics License Application (BLA) for bezlotoxumab and granted Priority Review with a Prescription Drug User Fee Act V action date of July 23, 2016. MK-1293 is an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes being developed in collaboration with Samsung Bioepis. In December 2015, the Company submitted an application for regulatory approval in the EU and plans to submit MK-1293 to the FDA in 2016. MK-5172A, Zepatier, under review in the EU for the treatment of chronic HCV, is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg). Zepatier was approved by the FDA in January 2016 for the treatment of adult patients with chronic HCV GT1 or GT4 infection, with or without ribavirin. V419 is an investigational pediatric hexavalent combination vaccine, DTaP5-IPV-Hib-HepB, under review with the FDA that is being developed. This vaccine is designed to help protect against six important diseases - diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B. On November 2, 2015, the FDA
merck & co. inc. (MRK:New York)
2000 Galloping Hill Road
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