Sanofi and Regeneron Report Positive Results With Alirocumab From Phase 2 Japanese Study

  Sanofi and Regeneron Report Positive Results With Alirocumab From Phase 2
                                Japanese Study

New investigational PCSK9 inhibitor shown to significantly reduce LDL-C among
Japanese patients

PR Newswire

BRIDGEWATER, N.J. and TARRYTOWN, N.Y., April 1, 2014

BRIDGEWATER, N.J. and TARRYTOWN,N.Y., April 1, 2014 /PRNewswire/ -- Sanofi
(EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) today announced that the first Phase 2 study with alirocumab, an
investigational monoclonal antibody targeting PCSK9 (proprotein convertase
subtilisin/kexin type 9), in Japanese patients met its primary endpoint. The
results demonstrated that the mean low-density lipoprotein-cholesterol (LDL-C,
or "bad" cholesterol) percentage reduction from baseline to week 12, the
primary efficacy endpoint of the study, was significantly greater in patients
randomized to receive one of three doses of alirocumab administered every
other week (Q2W) -- 150 milligrams (mg), 75 mg, and 50 mg, in combination with
statin therapy, compared to patients receiving placebo.

At Week 12, the mean percentage reduction in LDL-C from baseline in patients
receiving alirocumab 50 mg Q2W was 55 percent, alirocumab 75 mg Q2W was 62
percent and alirocumab 150 mg Q2W was 72 percent, compared to 3 percent in the
placebo group (p<0.0001 vs. placebo for all treatment arms). All patients in
each of the alirocumab groups achieved LDL-C levels of <100 mg/dL, compared to
8 percent of patients in the placebo group.

Treatment emergent adverse events (TEAEs) in this study were reported by 52
percent of patients in the alirocumab 50 mg group, 48 percent of patients in
the 75 mg group, 64 percent of patients in the 150 mg group, compared to 32
percent in the placebo group. The most frequently reported TEAEs were
nasopharyngitis, injection site reaction, back pain, cystitis and ligament
sprain.

"We are delighted with the findings from the first Phase 2 trial with
alirocumab in Japanese patients. Not only was alirocumab shown, in this
study, to significantly reduce LDL-C in this patient population, the results
of this study also demonstrate the potential efficacy of alirocumab at a range
of doses," said Jay Edelberg M.D., Ph.D., Head of the PCSK9 Development and
Launch Unit, Sanofi Group.

"Hypercholesterolemia is a growing problem in Japan and many patients are
poorly-controlled on statins," commented George D. Yancopoulos, M.D., Ph.D.,
Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.
"The results from this trial support the efficacy and safety of alirocumab at
a range of doses in Japanese patients."

About the Alirocumab Phase 2 Japanese Study
This multicenter, placebo-controlled Phase 2 study randomized approximately
100 patients with LDL-C greater than or equal to 100 mg/dL receiving
lipid-modifying therapy. 25 patients per group were randomized to receive one
of three doses of alirocumab dosed subcutaneously every other week (Q2W) --
150 milligrams (mg), 75 mg or 50 mg, or placebo, all in combination with
statin therapy.

The primary study endpoint was the percentage change in calculated LDL-C from
baseline to Week 12. The secondary study endpoints included absolute change
in calculated LDL-C from baseline to Week 12 and percent and absolute changes
in other lipid parameters at Week 12.

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-C from the blood. Moreover, statins increase
the level of circulating PCSK9, which in turn may reduce the density of LDL-C
receptors available to clear LDL-C from the circulation. Blocking the PCSK9
pathway is therefore a potentially novel mechanism for lowering LDL-C.

About alirocumab
Alirocumab is an investigational, fully-human monoclonal antibody that targets
and blocks PCSK9. It is administered via subcutaneous injection. By
inhibiting PCSK9, a determinant of circulating LDL-C levels in the blood,
alirocumab has been shown in pre-clinical studies to increase the number of
LDL receptors on hepatocytes, thereby lowering LDL-C.

The investigational agent described above is currently under clinical
development, and its safety and efficacy have not been fully evaluated by any
regulatory authority.

About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).

About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading science-based biopharmaceutical company based in
Tarrytown, New York, that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical conditions.
Regeneron markets medicines for eye diseases, colorectal cancer, and a rare
inflammatory condition and has product candidates in development in other
areas of high unmet medical need, including hypercholesterolemia, rheumatoid
arthritis, asthma, and atopic dermatitis. For additional information about
the company, please visit www.regeneron.com.

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include projections and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product development
and potential, and statements regarding future performance. Forward-looking
statements are generally identified by the words "expects", "anticipates",
"believes", "intends", "estimates", "plans" and similar expressions. Although
Sanofi's management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally beyond the
control of Sanofi, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA, regarding
whether and when to approve any drug, device or biological application that
may be filed for any such product candidates as well as their decisions
regarding labelling and other matters that could affect the availability or
commercial potential of such product candidates, the absence of guarantee that
the product candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group's
ability to benefit from external growth opportunities, trends in exchange
rates and prevailing interest rates, the impact of cost containment policies
and subsequent changes thereto, the average number of shares outstanding as
well as those discussed or identified in the public filings with the SEC and
the AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2013. Other than as
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.

Regeneron Forward-Looking Statements
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. Words such as "anticipate," "expect," "intend,"
"plan," "believe," "seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking statements, although
not all forward-looking statements contain these identifying words. These
statements concern, and these risks and uncertainties include, among others,
the nature, timing, and possible success and therapeutic applications of
Regeneron's products, product candidates, and research and clinical programs
now underway or planned, including without limitation alirocumab; unforeseen
safety issues resulting from the administration of products and product
candidates in patients, including serious complications or side effects in
connection with the use of Regeneron's product candidates in clinical trials,
including without limitation the Phase 2 trial of alirocumab in Japanese
patients and the ODYSSEY global Phase 3 trial program; 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 product
candidates; competing drugs and product candidates that may be superior to
Regeneron's products and product candidates; uncertainty of market acceptance
and commercial success of Regeneron's products and product candidates; the
ability of Regeneron to manufacture and manage supply chains for multiple
products and product candidates; coverage and reimbursement determinations by
third-party payers, including Medicare and Medicaid; unanticipated expenses;
the costs of developing, producing, and selling products; the ability of
Regeneron to meet any of its sales or other financial projections or guidance
and changes to the assumptions underlying those projections or guidance; the
potential for any license or collaboration agreement, including Regeneron's
agreements with Sanofi and Bayer HealthCare, to be cancelled or terminated
without any further 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, 2013. The reader is
cautioned not to rely on any forward-looking statements made by Regeneron.
Regeneron does not undertake any obligation to update publicly any
forward-looking statement, including without limitation any financial
projection or guidance, whether as a result of new information, future events,
or otherwise.

Sanofi Contacts:

US Media Relations
MK Steel
Tel: 908.981.6031
E-mail: marykathryn.steel@sanofi.com

Investor Relations
George Grofik
Tel: 908.981.3779
george.grofik@sanofi.com

Elizabeth Baxter
PCSK9 Communications
Tel: 1 (908) 981-5360
Mobile: 1 (908) 340-7811
E-mail: Elizabeth.Baxter@sanofi.com

Regeneron Contacts:

Media
Relations   Investor Relations

Sandy                                                     Manisha Narasimhan, Ph.D.
Sexton
                                                          Tel: +1 914-847-5126
Tel: +1 914-
847-3358            manisha.narasimhan@regeneron.com

sandra.sexton@regeneron.com      



SOURCE Regeneron Pharmaceuticals, Inc.

Website: http://www.regeneron.com
 
Press spacebar to pause and continue. Press esc to stop.