Sanofi and Regeneron To Present Alirocumab Clinical Data at the American College of Cardiology's 63rd Annual Scientific Session

   Sanofi and Regeneron To Present Alirocumab Clinical Data at the American
            College of Cardiology's 63rd Annual Scientific Session

Companies to Host Investor Conference Call on Alirocumab on March 31 at 9 AM
EDT

PR Newswire

PARIS and TARRYTOWN, N.Y., March 27, 2014

PARIS and TARRYTOWN, N.Y., March 27, 2014 /PRNewswire/ -- Sanofi (EURONEXT:
SANand NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that data from alirocumab clinical studies will be presented at the
American College of Cardiology's (ACC) 63rd Annual Scientific Session in
Washington, D.C. March 29-31. Alirocumab is an investigational monoclonal
antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9)
currently in Phase 3 studies.

"ACC marks the beginning of the presentation of our Phase 3 ODYSSEY data in
2014, with the first full data results from the Phase 3 ODYSSEY MONO study,"
said Jay Edelberg M.D., Ph.D., Head of the PCSK9 Development and Launch Unit,
Sanofi Group. "We are presenting new data with our 150 mg four-week dosing
regimen in individuals not receiving statins and long-term data in
heterozygous familial hypercholesterolemia patients."

"Despite the availability of lipid-lowering therapies, millions of people
worldwide are unable to satisfactorily control their levels of low-density
lipoprotein-cholesterol," said George D. Yancopoulos, M.D., Ph. D., Chief
Scientific Officer of Regeneron and President of Regeneron Laboratories. "We
have designed a robust Phase 3 ODYSSEY program that consists of 14 studies in
more than 23,500 patients and we look forward to reporting Phase 3 data from
the majority of the ODYSSEY clinical studies later this year."

Sanofi and Regeneron are developing alirocumab as a potential new treatment
for patients with moderate and high cardiovascular risk who face challenges in
achieving control of their low-density lipoprotein-cholesterol (LDL-C) levels.
Sanofi and Regeneron plan to submit applications for global regulatory
approval of alirocumab based on the Phase 3 ODYSSEY program.

The following data will be presented at ACC on March 30 at 9:30 AM EDT:

PHASE 3 ODYSSEY MONO FULL RESULTS:

  oAbstract #1183-125: A 24-Week Study of Alirocumab as Monotherapy versus
    Ezetimibe: The First Phase 3 Data of a Proprotein Convertase
    Subtilisin/Kexin Type 9 Inhibitor

  24-Week Phase 3 ODYSSEY MONO study comparing the LDLc –lowering efficacy and
  safety of alirocumab vs. ezetimibe in patients not receiving statin or other
  lipid-lowering therapies^1

  Eli M. Roth – Sterling Research Group, Cincinnati, OH, USA

OTHER ALIROCUMAB CLINICAL DATA:

  oAbstract #1183-126: One Year Open-Label Treatment with Alirocumab 150 mg
    Every Two Weeks in Heterozygous Familial Hypercholesterolemic Patients

  Phase 2 study assessing initial 52-week safety and efficacy data (as part of
  a longer term four-year open label treatment extension) in patients taking
  alirocumab 150 mg every two weeks^2

  Evan A. Stein – Metabolic and Atherosclerosis Research Center, Cincinnati,
  OH, USA

  oAbstract #1183-131: Randomized, Partial Blind Study of the
    Pharmacodynamics, Pharmacokinetics and Safety of Multiple Subcutaneous
    Doses of Alirocumab, a Fully Human Monoclonal Antibody to Proprotein
    Convertase Subtilisin/Kexin Type 9, Administered Every 4 Weeks Alone or In
    Combination with Ezetimibe or Fenofibrate in Healthy Subjects

  Partial blind study in three parallel groups of healthy subjects not on
  lipid-lowering therapy, comparing the efficacy of alirocumab 150 mg Q4W as
  monotherapy or with ezetimibe or fenofibrate over a four week dosing
  interval^3

  Jacques Rey – Sanofi, Paris, France

  oAbstract # 1183-128: Effects of Alirocumab, a Fully Human Monoclonal
    Antibody to Proprotein Convertase Subtilisin/Kexin Type 9, on Lipoprotein
    Particle Concentrations Determined by Nuclear Magnetic Resonance: Substudy
    of a Randomized Double-Blind Phase 2 Clinical Trial

  Study determining alirocumab's effect on LDL particle and other lipid
  particle concentrations versus placebo^4

  Michael J. Koren – Jacksonville Center for Clinical Research, Jacksonville,
  FL, USA

  oAbstract #1183-133: A Randomized Study of the Relative Bioavailability,
    Pharmacodynamics, and Safety of Alirocumab, a Fully Human Monoclonal
    Antibody to Proprotein Convertase Subtilisin/Kexin Type 9, after Single
    Subcutaneous Administration at Three Different Injection Sites in Healthy
    Subjects

  Single-center, open-label, randomized Phase 1 study comparing the
  bioavailability and adverse events of a single dose of alirocumab in
  different injection sites (arm, leg, abdomen)^5

  Catherine Lunven – Sanofi, Paris, France



Investor Relations Conference Call on Alirocumab
The companies will host an IR Thematic Conference Call for the financial
community focusing on alirocumab during ACC. The conference call will take
place on Monday, March 31, 2014 (3 p.m. CET / 2 p.m. BST/ 9 a.m. EDT / 6 a.m.
PDT). The call will be available through audio webcast at www.sanofi.com and
www.regeneron.com and also via the following telephone numbers:
France +33 (0) 1 70 77 09 40
UK +44 (0) 203 367 9453
U.S. +1 866 907 5925

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.

ODYSSEY is the global Phase 3 trial program for investigational compound
alirocumab. ODYSSEY currently comprises 14 clinical trials enrolling more than
23,500 patients with hypercholesterolemia in 2,000 study centers across North
and South America, Europe, Australia, South Africa, and Asia. Alirocumab is
currently under clinical development, and its safety and efficacy have not
been fully evaluated by any regulatory authority.

About Sanofi
Sanofi, a 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.

References

1.Roth E, Taskinen M-R, Ginsberg HN, et al. A 24-week study of alirocumab as
    monotherapy versus ezetimibe: the first 6-month Phase 3 data of a
    proprotein convertase subtilisin/kexin type 9 inhibitor. Poster #125 
    (session #1183)  at the American College of Cardiology's 63^rd Annual
    Scientific Session, March 29-31.
2.Stein EA, Bergeron J, Gaudet D, et al. One year open-label treatment with
    alirocumab 150 mg every two weeks in heterozygous familial
    hypercholesterolemic patients. Poster #126 (session #1183)  at the
    American College of Cardiology's 63^rd Annual Scientific Session, March
    29-31.
3.Rey J, Poitiers F, Paehler T, et al. Randomized, partial blind study of
    the pharmacodynamics, pharmacokinetics and safety of multiple subcutaneous
    doses of alirocumab, a fully human monoclonal antibody to proprotein
    convertase subtilisin/kexin type 9, administered every 4 weeks alone or in
    combination with ezetimibe or fenofibrate in healthy subjects. Poster #131
    (session #1183)  at the American College of Cardiology's 63^rd Annual
    Scientific Session, March 29-31.
4.Koren MJ, Kereiakes D, Pourfarzib R, et al. Effects of Alirocumab, a Fully
    Human Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type
    9, on Lipoprotein Particle Concentrations Determined by Nuclear Magnetic
    Resonance: Sub-Study of a Randomized Double-Blind Phase II Clinical Trial.
    Poster #128 (session #1183)  at the American College of Cardiology's 63^rd
    Annual Scientific Session, March 29-31.
5.Lunven C, Paehler T Lewanczyk P, et al. Randomized Study of the Relative
    Bioavailability, Pharmacodynamics, and Safety of Alirocumab, a Fully Human
    Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9,
    After Single Subcutaneous Administration at Three Different Injection
    Sites in Healthy Subjects. Poster #133 (session #1183)  at the American
    College of Cardiology's 63^rd Annual Scientific Session, March 29-31.

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 3 ODYSSEY MONO study and the ODYSSEY
global Phase 3 trial program, which may affect the global filing plan for
alirocumab; 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:

Media Relations

Jack Cox

Tel: +33 (0)1 53 77 94 74

jack.cox@sanofi.com             Investor Relations

                               Sébastien Martel

Elizabeth Baxter                Tel.: +33 (0)1 53 77 45 45

Global Communications for PCSK9 ir@sanofi.com

Tel: +1 908-981-5360

Mobile: +1 908-340-7811

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
Website: http://www.sanofi.com
 
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