Regeneron Pharmaceuticals, Inc. operates as an integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. The company commercializes medicines for eye diseases, colorectal cancer, and a rare inflammatory condition; and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis (RA), asthma, and atopic dermatitis. Marketed Products The company has three marketed products: EYLEA (aflibercept) Injection EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, which is available in the United States, European Union (EU), Japan, and certain other countries outside the United States for the treatment of neovascular age-related macular degeneration (wet AMD) and macular edema following central retinal vein occlusion (CRVO). In addition, in July 2014, August 2014, and November 2014, the U.S. Food and Drug Administration (FDA), European Commission, and Japanese Ministry of Health, Labour and Welfare (MHLW), respectively, approved EYLEA for the treatment of diabetic macular edema (DME). In September 2014, the Japanese MHLW approved EYLEA for myopic choroidal neovascularization. In October 2014, the FDA approved EYLEA for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch RVO (BRVO). In November 2014, the FDA accepted for priority review the supplemental biologics application for EYLEA for the treatment of diabetic retinopathy in patients with DME, with a target action date of March 30, 2015. The company is collaborating with Bayer HealthCare LLC (Bayer HealthCare) on the global development and commercialization of EYLEA outside the United States. Regulatory applications have been submitted for EYLEA in Europe and Japan for the treatment of macular edema following BRVO. In January 2015, the European Committee for Medicinal Products for Human Use recommended EYLEA for approval for the treatment of visual impairment due to macular edema secondary to CRVO or BRVO. ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion, known in the scientific literature as VEGF Trap, which is available in the United States, EU, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Regulatory applications for marketing authorization of ZALTRAP for the treatment of previously treated mCRC patients in other countries have also been submitted and are under review by the respective regulatory agencies. The company and Sanofi collaborate on the development and commercialization of ZALTRAP worldwide. ARCALYST (rilonacept) Injection for Subcutaneous Use ARCALYST (rilonacept) Injection for Subcutaneous Use, which is available in the United States for the treatment of cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and muckle-wells syndrome, in adults and children 12 years and older. The company has 17 product candidates in clinical development, all of which are discovered in its research laboratories. These consist of 2 Trap-based clinical programs and 15 fully human monoclonal antibody product candidates. The company’s Trap-based clinical programs comprise: EYLEA: It is in Phase 3 clinical development for the treatment of wet AMD (Asia) and DME (Asia) in collaboration with Bayer HealthCare. EYLEA is also being studied in combination with an antibody to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta) and an antibody to angiopoietin-2 (Ang2). ZALTRAP: It is in Phase 3 clinical development in metastatic colorectal cancer in the Asia-Pacific region (in collaboration with Sanofi). The company’s antibody-based clinical programs in collaboration with Sanofi comprise: PRALUENT (alirocumab/REGN727): It is an antibody to PCSK9.
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