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Sanofi and Regeneron Report Positive Preliminary Phase 2 Program Results for Anti-PCSK9 Antibody in Hypercholesterolemia
Date:11/9/2011

PARIS and TARRYTOWN, N.Y., Nov. 10, 2011 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive preliminary results from the Phase 2 study program in which patients with elevated low-density lipoprotein cholesterol (LDL-C) were treated with REGN727/SAR236553.

REGN727/SAR236553 is a novel, high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).  Blocking the PCSK9 pathway is a novel mechanism for lowering LDL-C, the leading known risk factor for coronary artery disease.

One Phase 2 trial studied patients with heterozygous familial hypercholesterolemia (heFH) with elevated cholesterol (LDL-C>/=100mg/dL) despite lipid lowering therapy (statins with or without ezetemibe).  The objective of the study was to compare the effect of adding REGN727/ SAR236553 to the existing lipid lowering therapy in heFH patients.  In the primary efficacy analysis of the study, after 12 weeks of treatment, patients who received different dosing regimens of REGN727/SAR236553 achieved mean LDL-C reductions from baseline ranging from approximately 30% to greater than 65% depending on the dosing regimen of REGN727/SAR236553 compared to a mean reduction of 10% with placebo (p<0.05 for all dose groups).  Patients in the study are being followed for a total of 20 weeks for safety.

In this trial, REGN727/SAR236553 was generally well tolerated over 12 weeks.  There were no elevations in LFTs >3 times the upper limit of normal (ULN) and no cases of elevated CPK reported.  The most common adverse event was injection site reaction.  There were no serious adverse events on active treatment.  Full safety data from the 8-week po
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SOURCE Regeneron Pharmaceuticals, Inc.
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