PARIS and TARRYTOWN, N.Y., March
26, 2012 /PRNewswire/ -- Sanofi (EURONEXT: SAN and
NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that data from two Phase 2 trials with SAR236553/REGN727, an investigational,
high-affinity, subcutaneously administered, fully-human antibody
targeting PCSK9 (proprotein convertase subtilisin/kexin type 9),
were presented at the American College of Cardiology's (ACC) 61st
Annual Scientific Meeting in Chicago.
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The data showed that treatment with SAR236553/REGN727 over 8 to 12 weeks
significantly reduced mean low-density lipoprotein-cholesterol
(LDL-C, or "bad" cholesterol) by 40% to 72% in patients with
elevated LDL-C on stable dose of statins.(1),(2)
"Many patients are not able to lower their LDL-C sufficiently
by diet and medication despite the availability of statins. As
guidelines are evolving, there is a real need for additional
lipid-lowering medications," said Dr. James McKenney, President and CEO of National
Clinical Research, Inc., Professor Emeritus of the Virginia Commonwealth University School of
Pharmacy, USA, and Principal
Investigator of the study. "These trial results suggest that
SAR236553/REGN727 may enable patients
for whom statins are insufficient to further reduce LDL-C."
Presented today in a late-breaking clinical trials session at
the ACC meeting, "Study DFI11565," the Phase 2 dose-finding
clinical trial enrolled 183 patients with elevated LDL-C (greater
than or equal to 100 mg/dL) despite being on a stable dose of
atorvastatin. The objective of the study was to evaluate the effect
of adding SAR236553/REGN727 to
existing statin therapy. Across the five different dose regimens
tested, patients receiving SAR236553/REGN727 for 12 weeks achieved and
sustained a mean LDL-C reduction from baseline of 40% to 72%,
compared to 5% in patients receiving placebo (p
