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, high low-density lipoprotein (LDL) cholesterol, and a rare inflammatory condition; and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis (RA), asthma, atopic dermatitis, pain, and infectious diseases. Marketed Products The company has three marketed products, such as: 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), diabetic macular edema (DME), macular edema following retinal vein occlusion, which includes macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion. EYLEA is also available in Japan and the EU for the treatment of myopic choroidal neovascularization and in the United States for the treatment of diabetic retinopathy in patients with DME. Bayer HealthCare LLC (Bayer HealthCare) has additional regulatory applications for EYLEA for various indications pending in other countries. The company is collaborating with Bayer HealthCare on the global development and commercialization of EYLEA outside the United States. Praluent (alirocumab) Injection Praluent (alirocumab) Injection, which is available in the United States where it is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol. In September 2015, the European Commission granted marketing authorization of Praluent for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia and non-familial) or mixed dyslipidemia as an adjunct to diet, including in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated dose of a statin; or alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The company is collaborating with Sanofi on the global development and commercialization of Praluent. 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 13 product candidates in clinical development, all of which were discovered in its research laboratories. These consist of a Trap-based clinical program and 12 fully human monoclonal antibody product candidates. Each of the antibodies is generated using its VelocImmune technology. The company’s Trap-based clinical programs comprise: EYLEA: It is in Phase 3 clinical development for the treatment of neovascular glaucoma (in Japan) in collaboration with Bayer HealthCare. aflibercept 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). The company’s antibody-based clinical programs in collaboration with Sanofi comprise: Praluent It is an antibody to PCSK9. In Phase 3 clinical development for LDL cholesterol reduction and for the prevention of cardiovascular events. In July 2015, the U.S. Food and Drug Administration (FDA) approved Praluent as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical ASCVD, who require additiona
regeneron pharmaceuticals (RGO:Munich)
777 Old Saw Mill River Road
Tarrytown, NY 10591
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