Sanofi and Regeneron Announce Patient Enrollment in Cardiovascular Outcomes Trial with Antibody to PCSK9 for

 Sanofi and Regeneron Announce Patient Enrollment in Cardiovascular Outcomes
            Trial with Antibody to PCSK9 for Hypercholesterolemia

18,000 patient Phase 3 outcomes study will evaluate the impact of antibody to
PCSK9 on cardiovascular events

PR Newswire

PARIS and TARRYTOWN, N.Y., Nov. 5, 2012

PARIS and TARRYTOWN, N.Y., Nov. 5, 2012 /PRNewswire/ --Sanofi (EURONEXT: SAN
and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that the ODYSSEY OUTCOMES trial, a Phase 3 cardiovascular outcomes
trial (CVOT) with SAR236553/REGN727 is now recruiting patients.
SAR236553/REGN727 is an investigational subcutaneously administered,
fully-human antibody that is being evaluated for its impact on lowering
low-density lipoprotein cholesterol (LDL-C) by targeting PCSK9 (proprotein
convertase subtilisin/kexin type 9).

The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who
recently suffered an acute coronary syndrome (ACS), from 49 countries across
six continents. With the start of this study, eleven trials are now
recruiting in the global SAR236553/REGN727 Phase 3 program.

"Despite widespread use of statin therapy, many patients at risk do not reach
recommended targets for LDL. Even among those who do reach targets, further
LDL lowering may further reduce the risks of coronary heart disease (CHD)
death, myocardial infarction (MI) and stroke," said Ph. Gabriel Steg M.D.,
Professor of Cardiology at the Hopital Bichat-Claude Bernard in Paris, France,
and co-Chair of the ODYSSEY OUTCOMES Steering Committee. "The ODYSSEY
cardiovascular (CV) outcomes trial will test the efficacy and safety of
SAR236553/REGN727 added to maximal doses of statins in reducing cardiovascular
morbidity and mortality in patients with recent ACS, a population at high risk
of CV events despite best contemporary therapy."

ODYSSEY OUTCOMES is a double-blind, randomized, placebo-controlled,
multi-national study. The primary objective of the study is to evaluate the
effect of SAR236553/REGN727 on the incidence of cardiovascular events in
patients who have experienced an ACS and are not at their LDL-C goal.
Patients will receive either a 1-milliliter (mL) injection of 75 milligrams
(mg) of SAR236553/REGN727 or placebo every two weeks, in addition to their
background of optimized lipid-lowering therapy. If patients do not reach a
predetermined LDL-C goal with the 75 mg dose they will be up-titrated to a
dose of 150 mg, also delivered as a 1 mL injection. The primary endpoint is a
composite of coronary heart disease (CHD) death, non-fatal MI, fatal and
non-fatal ischemic stroke, and unstable angina requiring hospitalization.
ODYSSEY OUTCOMES is being conducted under a Special Protocol Assessment (SPA)
agreed upon with the U.S. Food and Drug Administration (FDA).

About the Ongoing Phase 3 ODYSSEY Program

The broad Phase 3 ODYSSEY program is underway and will be conducted across
more than 2,000 study centers across the United States, Canada, Western and
Eastern Europe, South America, Australia and Asia. In addition to ODYSSEY
OUTCOMES, the Phase 3 ODYSSEY program includes the following studies:

  oODYSSEY FH I, FH II and HIGH FH, in patients with heFH who are not
    adequately controlled with their lipid-modifying therapy.
  oODYSSEY COMBO I and COMBO II, in patients with primary
    hypercholesterolemia at high cardiovascular risk who are not adequately
    controlled with their lipid-modifying therapy.
  oODYSSEY MONO, in patients with primary hypercholesterolemia.
  oODYSSEY ALTERNATIVE, in patients with primary hypercholesterolemia (heFH
    and non-familial hypercholesterolemia) who are unable to tolerate statins.
  oODYSSEY OPTIONS I and OPTIONS II, in patients with primary
    hypercholesterolemia at high cardiovascular risk or with heFH who are not
    adequately controlled on statins, in comparison to several second-line
    lipid-lowering strategies.
  oODYSSEY LONG TERM, in patients with hypercholesterolemia at high
    cardiovascular risk or patients with heFH inadequately controlled with
    their current lipid-modifying therapy.

Based on the cumulative efficacy and safety data from the SAR236553/REGN727
Phase 1 and Phase 2 clinical studies, 75 mg and 150 mg Q2W doses were chosen
to be tested in the Phase 3 program. The selection of these doses was also
supported by information from current lipid treatment guidelines and data from
large, completed CV event trials that have demonstrated a correlation between
the degree of LDL-C lowering and the resultant lowered risk for CV events.

Further information about the initiated Phase 3 studies can be found at

About PCSK9
PCSK9 is known to be a determinant of circulating LDL-C 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, traditional
LDL-lowering therapies such as statins actually stimulate the production of
PCSK9, which limits their own ability to lower LDL-C. Blocking the PCSK9
pathway is therefore a potentially novel mechanism for lowering LDL-C.

About SAR236553/REGN727
SAR236553/REGN727, created using Regeneron's VelocImmune® technology, is a
fully human monoclonal antibody targeting PCSK9, administered via subcutaneous
injection. By inhibiting PCSK9, a determinant of circulating LDL-C levels in
the blood, SAR236553/REGN727 has been shown in pre-clinical studies to
increase the number of LDL receptors which can clear circulating LDL-C from
the bloodstream.

About Sanofi
Sanofi, a global and diversified 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 fully integrated biopharmaceutical company that discovers,
invents, develops, manufactures, and commercializes medicines for the
treatment of serious medical conditions. Regeneron markets three products in
the United States, EYLEA^® (aflibercept) Injection, ZALTRAP^®
(ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST^®
(rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with
Sanofi. Phase 3 studies are in progress with EYLEA in two additional
indications and with product candidates sarilumab and REGN727. Regeneron has
active research and development programs in many disease areas, including
ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional
information and recent news releases are available on the Regeneron web site

Media Webcast on the ODYSSEY OUTCOMES Study
Sanofi and Regeneron will host a live media webcast on Monday, Nov. 5 2012 at
3:00PM Paris CET/ 2:00PM London GMT/ 9:00AM New York EST/ 6:00AM Los Angeles
PST. A Q&A session will take place following the presentation. To register
for this event, please click here:

Investor Relations Conference Call on PCSK9
Sanofi and Regeneron will host a conference call for the financial community
during the upcoming American Heart Association Scientific Sessions, focusing
on the LDL cholesterol-lowering PCSK9 Antibody (SAR236553/ REGN727) following
the launch of ODYSSEY, our comprehensive Phase 3 clinical program. It will
take place on Monday Nov. 5 2012 at 4:15PM Paris CET / 3:15PM London GMT/
10:15AM New York EST/ 7:15AM Los Angeles PST. It will be accessible through
audio webcast at and and also via the
following telephone numbers.

Participant Toll-Free Dial-In Number: 0800 910 374
Participant Toll Dial-In Number: +33 1 76 74 89 88

Participant Toll-Free Dial-In Number: (888) 660 6127
Participant International Dial-In Number: +1 (973) 890 8355

Participant Toll-Free Dial-In Number: 0800 051 3806 or 0800 032 3836
Participant International Dial-In Number: +44 208 602 0818

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, 2011. 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. 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 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 Sanofi and
Bayer HealthCare, to be canceled or terminated, 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 and
its Form 10-Q for the quarter ended September 30, 2012. 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.

Media                                                      Investor Relations
Marisol                                                    Sebastien Martel
Tel: +33 (0) 1 53 77 45                                    Tel: +33 (0)1 53 77 45 45
Mobile: +33 (0) 6 08 18 94 78 E-mail:
Media                                                      Investor Relations
Peter                                                      Manisha Narasimhan, Ph.D.
Tel: 1 (914)                                               Tel: 1 (914) 847-5126

SOURCE Regeneron Pharmaceuticals, Inc.

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