Regeneron Announces Data Publication and Presentations with Potential First-in-Class Lipid-Lowering PCSK9 Antibody
- Phase 1 studies published in March 22, 2012 issue of New
England Journal of Medicine
- Phase 2 studies to be presented March 25-26 at American College
of Cardiology Annual Meeting
TARRYTOWN, N.Y., March 21, 2012 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that results of the Phase 1 clinical program with their investigational product REGN727/SAR236553, a novel, high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9 serine protease) were published in the March 22, 2012 issue of the New England Journal of Medicine. The primary author of the article, entitled "Effect of a Monoclonal Antibody to PCSK9 on LDL Cholesterol," was Evan A. Stein, M.D., Ph.D., Director of the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio, and Principal Investigator of one of the REGN727/SAR236553 Phase 1 clinical trials.
Additionally, results of two of three completed Phase 2 studies of REGN727/SAR236553 will be presented at oral sessions at the American College of Cardiology (ACC) annual meeting. The presentations are:
"A Randomized, Double-Blind, Placebo-Controlled Trial Of The
Safety And Efficacy of a Monoclonal Antibody To Proprotein
Convertase Subtilisin/Kexin Type 9 Serine Protease,
REGN727/SAR236553, in Patients With Primary Hypercholesterolemia"
will be presented by James M. McKenney, Pharm.D, Professor
Emeritus, Virginia Commonwealth University School of Medicine,
during a Late-Breaking Clinical Trial session on Monday, March 26
at 11:14 AM.
"The Effects of Co-administering a Monoclonal Antibody to
Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease,
REGN727/SAR236553, with 10 and 80 mg Atorvastatin Compared to 80 mg
Atorvastatin Alone in Patients With Primary Hypercholesterolemia"
will be presented by Eli M. Roth, M.D., Professor of Clinical
Medicine and Director of Preventive Cardiology for the Division of
Cardiology, University of Cincinnati College of Medicine, on
Sunday, March 25 at 8:25 AM.
About PCSK9
PCSK9 is known to be a determinant of circulating LDL levels, as it
binds to LDL receptors resulting in their degradation so that fewer
are available on liver cells to remove excess LDL-cholesterol from
the blood. Moreover, traditional LDL-lowering therapies such as
statins actually stimulate the production of PCSK9, which may limit
their ability to lower LDL-cholesterol. Blocking the PCSK9 pathway
is therefore a potentially novel mechanism for lowering
LDL-cholesterol.
About REGN727
REGN727/SAR236553 is a fully-human monoclonal antibody directed
against PCSK9, administered via subcutaneous injection. By
inhibiting PCSK9, a determinant of circulating LDL-cholesterol
levels in the blood, REGN727 increases the number of free LDL
receptors which can bind to circulating LDL and clear it from the
bloodstream. REGN727 was created using Regeneron's pioneering
VelocImmune® technology and is being developed by Regeneron in
collaboration with Sanofi.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that
discovers, invents, develops, manufactures, and commercializes
medicines for the treatment of serious medical conditions.
Regeneron markets two products in the United States, one for the
treatment of neovascular (wet) age-related macular degeneration and
another for the treatment of a rare inflammatory condition.
Additionally, Regeneron has three regulatory applications pending
before the U.S. Food and Drug Administration (FDA) and 10 drug
candidates in clinical development. More information and recent
news releases are available on the Regeneron web site at
www.regeneron.com
Regeneron Forward-Looking Statement
This news release includes forward-looking statements that involve
risks and uncertainties relating to future events and the future
performance of Regeneron, and actual events or results may differ
materially from these forward-looking statements. These statements
concern, and these risks and uncertainties include, among others,
the nature, timing, and possible success and therapeutic
applications of Regeneron's product candidates and research and
clinical programs now underway or planned, including without
limitation REGN727/SAR236553, unforeseen safety issues resulting
from the administration of products and product candidates in
patients, the likelihood and timing of possible regulatory approval
and commercial launch of Regeneron's late-stage product candidates,
determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron's ability to
continue to develop or commercialize Regeneron's products and drug
candidates, competing drugs that may be superior to Regeneron's
products and drug candidates, uncertainty of market acceptance of
Regeneron's products and drug candidates, unanticipated expenses,
the costs of developing, producing, and selling products, the
potential for any license or collaboration agreement, including
Regeneron's agreements with the Sanofi Group and Bayer HealthCare,
to be canceled or terminated without any product success, and risks
associated with third party intellectual property and pending or
future litigation relating thereto. A more complete description of
these and other material risks can be found in Regeneron's filings
with the United States Securities and Exchange Commission,
including its Form 10-K for the year ended December 31, 2011.
Regeneron does not undertake any obligation to update publicly any
forward-looking statement, whether as a result of new information,
future events, or otherwise, unless required by law.
Contact Information:
Media Relations
Investor Relations
Peter Dworkin
Manisha Narasimhan, Ph.D.
914.847.7640
914.847.5126
peter.dworkin@regeneron.com
manisha.narasimhan@regeneron.com
SOURCE Regeneron Pharmaceuticals, Inc.
Web Site: http://www.regeneron.com
Posted: March 2012
