Profile: Regeneron Pharmaceuticals Inc (REGN.OQ)

REGN.OQ on NASDAQ Stock Exchange Global Select Market

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Regeneron Pharmaceuticals, Inc. (Regeneron), incorporated in January 1988, is an integrated biopharmaceutical company, which discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. As of December 31, 2011, the Company had two marketed products: EYLEA (aflibercept) Injection and ARCALYST (rilonacept) Injection for Subcutaneous Use. As of December 31, 2011, the Company had 13 product candidates in clinical development. Its Trap-based, late-stage programs are EYLEA, which is being developed for the treatment of additional serious eye diseases; ZALTRAP (aflibercept), known in the scientific literature as vascular endothelial growth factor (VEGF) trap, which is being developed in oncology in collaboration with Sanofi; and ARCALYST, which is being developed for the prevention of gout flares in patients initiating uric acid-lowering treatment. Its antibody-based clinical programs include fully human monoclonal antibodies Sarilumab (REGN88), REGN727, REGN668, REGN421, REGN910, REGN475, REGN728, REGN1033, REGN846 and REGN1154.

EYLEA (aflibercept) Injection - wet AMD

EYLEA, known in the scientific literature as VEGF Trap-Eye, is a fusion protein locally administered in the eye, which bind vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) proteins, which are involved in the abnormal growth of new blood vessels. The Company is collaborating with Bayer HealthCare on the global development of EYLEA.

ARCALYST - CAPS

ARCALYST is a protein-based product designed to bind the interleukin-1 (called IL-1) cytokine and prevent its interaction with cell surface receptors. ARCALYST is available by prescription 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 12 and older.

EYLEA - Ophthalmologic Diseases

The Company, together with Bayer HealthCare, are evaluating EYLEA in phase-III programs in patients with central retinal vein occlusion (CRVO), diabetic macular edema (DME), and choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia. EYLEA was also in phase-III clinical studies for the treatment of CRVO, another cause of visual impairment. During the year ended December 31, 2011, the Company and Bayer HealthCare initiated phase-III studies to evaluate the safety and efficacy of EYLEA in DME. These clinical trials have three study arms.

ZALTRAP (aflibercept) also known as VEGF Trap - Oncology

ZALTRAP (aflibercept) is a fusion protein, which is designed to bind all forms of VEGF-A, VEGF-B, and PlGF, and prevent their interaction with cell surface receptors. VEGF-A (and to a lesser degree, PlGF) is required for the growth of new blood vessels (a process known as angiogenesis) that are needed for tumors to grow. ZALTRAP is being developed globally in cancer indications in collaboration with Sanofi. The Company and Sanofi globally collaborate on the development and commercialization of ZALTRAP.

ARCALYST (rilonacept) - Inflammatory Diseases

ARCALYST is being developed for the prevention of gout flares in patients initiating uric acid-lowering therapy. Gout is a common form of arthritis.

Sarilumab (REGN88; IL-6R Antibody) for inflammatory diseases

Sarilumab is a human monoclonal antibody to IL-6R generated using the Company VelocImmune technology. In July 2011, the Company and Sanofi announced that in the Phase-2b stage of the MOBILITY trial in rheumatoid arthritis, patients treated with sarilumab in combination with a RA treatment and methotrexate (MTX). The phase-IIb stage of the MOBILITY study was a 306-patient, dose-ranging, multi-national, randomized, multi-arm, double-blind, placebo-controlled study, which compared five different dose regimens of sarilumab in combination with MTX to placebo plus MTX.

REGN727 (PCSK9 Antibody) for LDL cholesterol reduction

The Company is used its VelocImmune technology to generate a human monoclonal antibody inhibitor of PCSK9, called REGN727, that is intended to lower LDL cholesterol. During 2011, three phase-II studies with subcutaneous regimens of REGN727 were initiated: a randomized, double-blind, multi-dose, placebo controlled, 75-patient trial in patients with heterozygous familial hypercholesterolemia (heFH); a randomized, double-blind, multi-dose, placebo controlled, 90-patient trial in combination with atorvastatin in patients with primary hypercholesterolemia, and a randomized, double-blind, multi-dose, placebo controlled, 180-patient trial in combination with atorvastatin in patients with hypercholesterolemia and on stable doses of atorvastatin. REGN727 is being developed in collaboration with Sanofi.

REGN668 (IL-4R Antibody) for allergic and immune conditions

REGN668 is a fully human monoclonal antibody generated using the Company's VelocImmune technology, which is designed to bind to IL-4R. REGN668 is in a Phase 1b study in patients with atopic dermatitis and a Phase II study in eosinophilic asthma. REGN668 is being developed in collaboration with Sanofi.

REGN421 (Dll4 Antibody) for advanced malignancies

REGN421 is a fully human monoclonal antibody to Dll4 generated using the Company's VelocImmune technology, and is in Phase 1 clinical development. REGN421 is being developed in collaboration with Sanofi.

REGN910 (ANG2 Antibody) for oncology

REGN910 is a human monoclonal antibody generated using the Company VelocImmune technology, which is being developed for cancer indications. REGN910 is being developed in collaboration with Sanofi.

REGN475 (NGF Antibody) for pain

REGN475 is a human monoclonal antibody to Nerve Growth Factor (NGF), generated using the Company VelocImmune technology, which is designed to block pain sensitization in neurons. Preclinical experiments indicate which REGN475 specifically binds to and blocks NGF activity and does not bind to or block cell signaling for closely related neurotrophins, such as Neurotrophin-Type 3 (NT-3), Neurotrophin-Type 4 (NT-4), or brain-derived neurotrophic factor (BDNF).

REGN728

The Company’s clinical trials for REGN728 are a fully human monoclonal antibody generated using its VelocImmune technology, against an undisclosed target. REGN728 is being developed in collaboration with Sanofi.

REGN1033

In December 2011, the Food & Drug Administration (FDA) accepted the Company's investigational new drug (IND) filing for REGN1033 and in January 2012, it initiated a phase-I clinical study. REGN1033 is a fully human monoclonal antibody generated using its VelocImmune technology, against an undisclosed target. REGN1033 is being developed in collaboration with Sanofi.

REGN846

REGN846 is a fully human monoclonal antibody generated using the Company’s VelocImmune technology, against an undisclosed target, and is being evaluated in a phase-IIa study in patients with atopic dermatitis. In July 2011, Sanofi elected not to continue co-development of REGN846, and Regeneron has sole global rights to REGN846.

REGN1154

REGN1154 is a fully human monoclonal antibody generated using the Company's VelocImmune technology, against an undisclosed target. In December 2011, it submitted a phase-I clinical trial protocol in Australia for REGN1154 under the clinical trial notification (CTN) regulatory process.

The Company competes with Roche group, Novartis, Pfizer Inc., Bayer HealthCare, Onyx Pharmaceuticals, Inc., Eli Lilly and Company, Abbott Laboratories, Sanofi, Merck & Co., Inc., Amgen Inc., AstraZeneca,Bristol-Myers Squibb, Johnson & Johnson, GlaxoSmithKline, Xoma Ltd., Imclone LLC, Biogen Idec, Inc. and Genentech.

Company Address

Regeneron Pharmaceuticals Inc

STE 10, 777 Old Saw Mill River R
TARRYTOWN   NY   10591-6707
P: +1914.8477000
F: +1914.3472113

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