Regeneron Provides Initial Data on Two Antibody Product Candidates
More corporate and clinical updates to be provided during company's first Investor Day on July 15, 2010
TARRYTOWN, N.Y., May 12 /PRNewswire-FirstCall/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ:REGN)
today provided an update on two antibody product candidates in its
pipeline and scheduled its first Investor Day to be held in New
York City on July 15, 2010. Both product candidates, REGN727
(SAR236553) and, REGN475 (SAR164877) are being developed with
sanofi-aventis under a global, strategic collaboration to discover,
develop, and commercialize fully human antibodies.
REGN727 (Anti-PCSK9)
REGN727 is a fully human antibody that targets Proprotein
Convertase Subtilisin/Kexin type 9 (PCSK9), a naturally-occurring
molecule involved in regulating cholesterol levels by modulating
low-density lipoprotein (LDL) cholesterol receptors. In an interim
efficacy analysis of a dose-escalating, randomized, double-blind,
placebo-controlled, Phase 1 trial in healthy volunteers, REGN727
achieved substantial, dose dependent decreases of LDL (bad)
cholesterol. The trial is ongoing with both intravenous and
subcutaneous routes of administration being studied. At the highest
dose tested to date, there was a highly significant lowering of
mean LDL cholesterol that lasted for more than one month following
a single dose, with a maximum mean reduction of more than 60%.
There have been no serious adverse events and no dose limiting
toxicities observed. Dose escalation is ongoing. Additional data
will be presented at an upcoming Investor Day event.
REGN475 (Anti-NGF)
REGN475 is a fully human antibody that selectively targets nerve
growth factor (NGF), a naturally-occurring molecule demonstrated to
modulate pain. In an interim efficacy analysis of a randomized,
double-blind, four-arm, placebo-controlled Phase 2 trial, in 217
patients with osteoarthritis of the knee, REGN475 demonstrated
significant improvements at the two highest doses tested as
compared to placebo in average walking pain scores over 8 weeks
following a single intravenous infusion (p<0.01). Pain was
measured by the Numeric Rating Scale (NRS), as well as the Western
Ontario and McMaster Osteoarthritis Index (WOMAC) pain and function
subscales.
The primary endpoint of this study is safety, and REGN475 was
generally well tolerated. Serious treatment emergent adverse events
were rare and balanced between placebo and drug arms with three
events (5.5%) in the placebo group and four events (2.5%) in the
combined REGN475 groups. The most frequent adverse events reported
among patients receiving REGN475 included sensory abnormalities,
arthralgias, hyper/hypo-reflexia, peripheral edema, and injection
site reactions. The types and frequencies of adverse events
reported were similar to those previously reported from other
investigational studies involving an anti-NGF antibody. Additional
data, which will include results following a second infusion at
week 8, will be presented at an upcoming Investor Day event.
Preliminary analysis of interim efficacy data from a Phase 2
trial of REGN 475 in the acute setting of nerve root compression
induced pain (acute sciatica) suggests that REGN475 therapy will
not be effective in this setting.
"We are extremely pleased by the productivity of our antibody
collaboration with sanofi-aventis, and the progress of the NGF and
PCSK9 antibodies, in particular," said Leonard S. Schleifer, M.D.,
Ph.D., President and Chief Executive Officer. "The collaboration is
not yet three years old, and we have been able to advance five
antibodies into the clinic, highlighting the power of our
VelocImmune® technology. Both REGN727 and REGN475 are being
developed to address areas of high unmet medical need and represent
important new additions to our clinical pipeline."
Regeneron will provide additional corporate and clinical updates
at its first Investor Day in New York City on July 15.
About REGN727 (Anti-PCSK9)
Coronary artery disease (CAD) remains the leading cause of death
in the U.S. for both men and women and is a leading cause of death
across the developed world. LDL cholesterol levels in the blood
have been shown to correlate with coronary artery disease risk, and
lowering LDL has been proven to reduce the risk of cardiac events,
such as death and heart attacks, in patients with CAD. However,
despite the relatively wide use of LDL cholesterol-lowering
therapies, including the statin class of agents, coronary artery
disease remains a leading cause of morbidity and mortality. REGN727
is a fully human monoclonal antibody intended to robustly lower LDL
cholesterol through a novel mechanism of action. REGN727 is
targeted at inhibiting PCSK9, which results in prevention of the
degradation of LDL receptors in the liver and facilitates LDL
clearance from the systemic circulation, thereby lowering LDL
levels in the blood.
About REGN475 (Anti-NGF)
Despite the availability of several classes of pain relievers,
millions of Americans continue to suffer from moderate to severe
pain due to a variety of medical disorders (e.g., osteoarthritis,
cancer, inflammation, neuropathic diseases, etc.). In addition to
inadequate pain relief, patients may be exposed to the adverse
effects of various pain medications, including gastrointestinal
distress and bleeding, renal effects, interference with control of
high blood pressure by antihypertensive agents, change in
cognition, and constipation. REGN475 is a fully human monoclonal
antibody against NGF (nerve growth factor), which is designed to
block pain sensitization in neurons. The efficacy and safety of
REGN475 are being evaluated in several Phase 2 studies in
short-term pain settings, as well in the treatment of moderate to
severe pain caused by osteoarthritis.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that
discovers, develops, and commercializes medicines for the treatment
of serious medical conditions. In addition to ARCALYST®
(rilonacept) Injection for Subcutaneous Use, its first
commercialized product, Regeneron has therapeutic candidates in
Phase 3 clinical trials for the potential treatment of gout,
diseases of the eye (wet age-related macular degeneration and
central retinal vein occlusion), and certain cancers. Additional
therapeutic candidates are in earlier stage development programs in
rheumatoid arthritis and other inflammatory conditions, pain,
cholesterol reduction, allergic and immune conditions, and cancer.
Additional information about Regeneron and recent news releases are
available on Regeneron's web site at www.regeneron.com.
Forward-Looking Statement
This news release discusses historical information and includes
forward-looking statements about Regeneron and its products,
development programs, finances, and business, all of which involve
a number of risks and uncertainties. These include, among others,
risks and timing associated with preclinical and clinical
development of Regeneron's drug candidates, determinations by
regulatory and administrative governmental authorities which may
delay or restrict Regeneron's ability to continue to develop or
commercialize its product and drug candidates, competing drugs that
are superior to Regeneron's product and drug candidates (a number
of other companies are developing product candidates targeting
PCSK9 and NGF and we expect these areas to be highly competitive),
uncertainty of market acceptance of Regeneron's product and drug
candidates, unanticipated expenses, the availability and cost of
capital, the costs of developing, producing, and selling products,
the potential for any collaboration agreement, including
Regeneron's agreements with the sanofi-aventis Group and Bayer
HealthCare, to be canceled or terminated without any product
success, and risks associated with third party intellectual
property. 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 (SEC), including its Form 10-K
for the year ended December 31, 2009 and Form 10-Q for the quarter
ended March 31, 2010. 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: Michael Aberman, M.D. Peter Dworkin Investor Relations Corporate Communications 914.345.7799 914.345.7640 michael.aberman@regeneron.com peter.dworkin@regeneron.com
Source: Regeneron Pharmaceuticals, Inc.
CONTACT: Michael Aberman, M.D., Investor Relations,
+1-914-345-7799,
michael.aberman@regeneron.com,
or Peter Dworkin, Corporate Communications,
+1-914-345-7640, peter.dworkin@regeneron.com
Web Site: http://www.regeneron.com/
Posted: May 2010
