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Sanofi and Regeneron Announce Publication of Phase 2 Results with LDL Cholesterol-Lowering PCSK9 Antibody in the New England Journal of Medicine
Date:10/31/2012

PARIS and TARRYTOWN, N.Y., Oct. 31, 2012 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that results from a Phase 2 trial of SAR236553/REGN727 in patients with primary hypercholesterolemia were published in the October 31, 2012 issue of the New England Journal of Medicine.

The study enrolled patients with primary hypercholesterolemia with elevated LDL-C (greater than or equal to 100 mg/dL) who were on a stable low dose of atorvastatin (10 mg).  The primary objective of the study was to compare the effect on LDL-C lowering of switching to a high dose of atorvastatin alone (80 mg) versus a high dose of atorvastatin combined with SAR236553/REGN727 administered in a 1ml injection every two weeks.

Patients who received SAR236553/REGN727 administered in a 1ml injection every two weeks plus atorvastatin 80 mg achieved a mean reduction of 73% in LDL-C, compared to a mean reduction of 17% for patients who switched to atorvastatin 80 mg alone (p<0.001) after eight weeks.  Ninety percent (90%) of patients achieved a pre-specified level of 70mg/dL compared to 17.2% for patients who switched to atorvastatin 80 mg alone (p<0.001).

The study also included a third arm in which SAR236553/REGN727 150mg administered in a 1ml injection every two weeks was added to the stable 10 mg of atorvastatin.  Ninety-six percent (96.6%) of patients achieved the pre-specified goal of 70mg/dL in this treatment group.

In this trial, the most common adverse events (AE) reported in patients treated with SAR236553/REGN727 plus atorvastatin were headache, dizziness, and diarrhea.  There was one serious AE in the SAR236553/REGN727 plus atorvastatin 80 mg group (dehydration) that was deemed not to be treatment
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SOURCE Regeneron Pharmaceuticals, Inc.
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