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Sanofi and Regeneron Announce Publication of Positive Phase 2 Results for Lipid-Lowering PCSK9 Antibody in The Lancet
Date:5/26/2012

amilial hypercholesterolemia is a common, serious, and often undiagnosed cause of early heart disease. There remains a high degree of unmet need in these patients as a large percentage are unable to reach optimal LDL-C goals despite being on maximal lipid-lowering therapy," said Evan A. Stein, M.D., Ph.D., Director of the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio, and Principal Investigator of the study. "These data suggest that SAR236553/REGN727 may provide a new option, on top of existing therapies, to lower LDL-cholesterol and finally reach LDL-C goals for these difficult-to-treat patients."

Sanofi and Regeneron also announced today that based on discussions with the U.S. and European regulatory authorities, they intend to initiate a global Phase 3 program with SAR236553/REGN727 in June. This will be the first Phase 3 program of an investigational drug targeting PCSK9.

"These data, along with recently presented data in patients with hypercholesterolemia, further support our belief that blocking PCSK9 with our antibody has the potential to offer a novel mechanism for lowering LDL-cholesterol in a broad range of patients," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. Dr. Elias Zerhouni, President, Global Research & Development, Sanofi, added: "Our global Phase 3 program will include patients with high unmet medical need, such as patients with familial hypercholesterolemia or with elevated cardiovascular risk who cannot reach their LDL-cholesterol goals with current standard therapies. The program reflects our excitement and commitment to develop this potential therapeutic option for these patients."

About PCSK9

PCSK9 is known to be a determinant of circulating LDL-C levels, as it binds to LDL receptors resulting in their degradation so that fewer are available on liver cells to remove excess LDL-C from the blood.['/>"/>

SOURCE Sanofi and Regeneron Pharmaceuticals, Inc
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