Profile: Regeneron Pharmaceuticals Inc (REGN.O)
Regeneron Pharmaceuticals, Inc., incorporated on January 11, 1988, is a 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 an inflammatory condition and have product candidates in development in other areas, including rheumatoid arthritis, asthma, atopic dermatitis, pain, cancer, and infectious diseases. The Company's marketed products include EYLEA (aflibercept) Injection, Praluent (alirocumab) Injection, ARCALYST (rilonacept) Injection for Subcutaneous Use, Kevzara (sarilumab) Solution for Subcutaneous Injection and ZALTRAP (ziv-aflibercept) Injection for intravenous infusion. As of December 31, 2016, the Company had 16 product candidates in clinical development, which consisted of a Trap-based clinical program and 15 fully human monoclonal antibody product candidates. Its antibodies are generated using its VelocImmune technology.
EYLEA 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 (RVO), which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO). EYLEA is also available in the EU, Japan, and certain other countries outside the United States for the treatment of myopic choroidal neovascularization (mCNV) and in the United States for the treatment of diabetic retinopathy in patients with DME. EYLEA has completed Phase III study for the treatment of Neovascular Glaucoma (NVG) in Japan. Praluent 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. Praluent is in Phase III clinical development for LDL cholesterol reduction and for the prevention of cardiovascular events.
ARCALYST is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children of 12 years and older. Kevzara is approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis having an inadequate response to or intolerance to one or more biologic or non-biologic disease modifying anti-rheumatic drugs (DMARDs). ZALTRAP 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.
The Company's antibody-based clinical programs include Sarilumab (REGN88), Dupixent (dupilumab/REGN668), REGN2810, REGN3500, REGN3767, Nesvacumab/aflibercept (REGN910-3), Fasinumab (REGN475), REGN2222, Evinacumab (REGN1500), Trevogrumab (REGN1033), REGN1908-1909, REGN1979, REGN3470-3471-3479 and REGN2477. Sarilumab is an antibody to the interleukin-6 receptor (IL-6R). Sarilumab is in clinical development in rheumatoid arthritis (Phase III) and non-infectious uveitis (Phase II). Dupixent is an antibody to the interleukin-4 receptor (IL-4R) alpha subunit. Dupixent is in clinical development in atopic dermatitis in adults (Phase III), atopic dermatitis in pediatric patients (Phase II), asthma in adults and adolescents (Phase III), and eosinophilic esophagitis (EoE) (Phase II). REGN2810 is an antibody to programed cell death protein 1 (PD-1). REGN2810 is in Phase I clinical development in solid tumors and advanced hematologic malignancies.
REGN3500 is an antibody to interleukin-33 receptor (IL-33) being developed for inflammatory diseases. The Company has initiated Phase I study in healthy volunteers for REGN3500. REGN3767 is an antibody to Lymphocyte Activation Gene 3 (LAG-3) protein. The Company has initiated Phase I study (administered alone or in combination with REGN2810) for REGN3767 in advanced malignancies. REGN910-3 is a combination product consisting of an antibody to angiopoietin-2 (Ang2) co-formulated with aflibercept for intravitreal injection for use in ophthalmology. REGN475 is an antibody to Nerve Growth Factor (NGF). The Company has initiated Phase III long-term safety and efficacy study for REGN475 in patients with osteoarthritis of knee and hip. REGN2222 is an antibody to the Respiratory Syncytial Virus-F (RSV-F) protein. REGN2222 is in Phase III clinical development for prevention of RSV infection. REGN1500 is an antibody to angiopoeitin-like 3 (Angptl-3). REGN1500 is in Phase II clinical development for the treatment of homozygous familial hypercholesterolemia (HoFH) and severe forms of hyperlipidemia.
REGN1033 is an antibody to myostatin (GDF8). REGN1033 has completed Phase II monotherapy study in patients with sarcopenia. REGN1908-1909 is an antibody to Feld1 and is in Phase I clinical development for the treatment of allergic disease. REGN1979 is a bispecific antibody against CD20 and CD3. REGN1979 is in Phase I clinical development for Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, and Acute Lymphoblastic Leukemia. REGN1979 is also being studied in combination with REGN2810 in B-cell malignancies. REGN3470-3471-3479 is an antibody to Ebola virus. The Company has initiated Phase I study for REGN3470-3471-3479 in healthy volunteers. REGN2477 is an antibody to Activin A being developed for Fibrodysplasia Ossificans Progressiva (FOP). The Company has initiated Phase I study for REGN2477 in combination with REGN1033 in healthy volunteers.
The Company competes with Roche Group, Novartis AG, Pfizer Inc., Allergan, Inc., Eli Lilly and Company, AbbVie Inc., Merck & Co., Inc., Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Company, Johnson & Johnson, GlaxoSmithKline plc, Alimera Sciences, Chengdu Kanghong Pharmaceutical Group, Pfenex Inc., Formycon AG, Bioeq GmbH, Alnylam Pharmaceuticals, Inc., The Medicines Company, Esperion Therapeutics, Inc., Gemphire Therapeutics Inc., Alder Biopharmaceuticals, Inc., Vitaeris Inc., Ablynx, R-Pharm, Bird Rock Bio, Inc., Biogen Inc., Teva and Galderma S.A.
Regeneron Pharmaceuticals Inc
777 Old Saw Mill River Rd
TARRYTOWN NY 10591-6717
Company Web Links
- FDA approves expanded label for Regeneron/Sanofi's cholesterol drug
- UPDATE 1-U.S. FDA approves expanded label for Regeneron/Sanofi's cholesterol drug
- U.S. FDA approves expanded label for Regeneron's cholesterol drug
- Genzyme and vaccines push up Sanofi's first quarter results
- UPDATE 1-Genzyme and vaccines push up Sanofi's Q1 results