regeneron pharmaceuticals (REGN) Key Developments
Sanofi and Regeneron Pharmaceuticals Announces Positive Phase III Results in Japanese Patients Treated with Praulent
Jul 10 15
Sanofi and Regeneron Pharmaceuticals announced results of a Phase III clinical study in Japanese patients treated with the investigational therapy Praluent (alirocumab), targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). The Phase III trial (ODYSSEY JAPAN) met its primary endpoint - demonstrating low-density lipoprotein cholesterol (LDL-C) - in Japanese patients with hypercholesterolaemia at high cardiovascular risk and/or with high-cholesterol owing to the medical condition heterozygous familial hypercholesterolaemia (HeFH). The 24-week trial involved 216 Japanese patients treated with Praulent alongside statins. Patient groups were administered with a dose of 75 mg initially. That dose was increased to 150 mg for two patients who failed to reach their LDL-C target by week 8. The mean LDL-C value at baseline was 141.2 mg/dL. Praluent demonstrated significant cholesterol-lowering ability with patients showing an average 64% reduction in LDL-C.
Regeneron Pharmaceuticals Wins Japanese Approval for EYLEA (Aflibercept) Injection for Treating Retinal Vein Occlusion
Jun 29 15
Regeneron Pharmaceuticals reported that they won approval for EYLEA (aflibercept) Injection in Japan for the treatment of patients with macular edema secondary to retinal vein occlusion (RVO), a significant cause of vision impairment and a chronic disease that requires early and ongoing management to obtain the best possible vision. This approval was awarded to Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin Ltd, by the Ministry of Health, Labour and Welfare (MHLW). This Japanese approval is based on positive results from the company's double-masked, randomized, active-controlled phase 3 VIBRANT study in patients with visual impairment due to macular edema secondary to BRVO. The company stated the primary endpoint was the proportion of subjects who gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity.
Regeneron Pharmaceuticals, Inc. Approves Amendment to Certificate of Incorporation
Jun 17 15
Regeneron Pharmaceuticals, Inc. announced that at the annual meeting of shareholders held on June 12, 2015 approved an amendment to the company's certificate of incorporation to increase the number of authorized shares of capital stock and common stock.
Regeneron Pharmaceuticals Inc. Announces FDA Approval of Sanofi and Regeneron's Praluent(R) (Alirocumab) Injection
Jun 9 15
Sanofi and Regeneron Pharmaceuticals, Inc. announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of the investigational therapy Praluent® (alirocumab) Injection. The Committee voted 13 to three (with no abstentions) that Sanofi and Regeneron had sufficiently established that the low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations.
Regeneron Pharmaceuticals Inc. Announces Updates on Phase 3 Study of Sarilumab
May 21 15
Regeneron Pharmaceuticals Inc. announced that a Phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks, compared to placebo. The study, called SARIL-RA-TARGET, evaluated the efficacy and safety of two subcutaneous sarilumab doses versus placebo, added to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy in RA patients who were inadequate responders to or intolerant of TNF-alpha inhibitors (TNF-IR). The SARIL-RA-TARGET trial enrolled 546 TNF-IR patients who were randomized to one of three treatment groups self-administered subcutaneously (SC) every other week (Q2W): sarilumab 200 milligrams (mg), sarilumab 150 mg, or placebo, in addition to DMARD therapy. Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in both co-primary endpoints (p greater than 0.001): Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20% improvement (ACR20), were as follows: 61% in the sarilumab 200 mg group; 56% in the sarilumab 150 mg group; and 34% in the placebo group, all in combination with DMARD therapy.