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

Paris, France and Tarrytown, NY, March 27, 2014 - Sanofi (EURONEXT : SAN and 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 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 150mg 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 (LDLc) 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:

PHASE 3 ODYSSEY MONO FULL RESULTS:

• Abstract #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. ezetemibe in patients not receiving statin or other lipid-lowering therapies 1

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

OTHER ALIROCUMAB CLINICAL DATA:

• Abstract #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

• Abstract #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 ezetemibe or fenofibrate over a four week dosing interval 3

Jacques Rey - Sanofi, Paris, France

• Abstract # 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

• Abstract #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

Posters are embargoed until the beginning of the presentation session (9:30 a.m. EDT, March 30). Abstracts are currently available on the ACC website.

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 LDLc levels in the blood, alirocumab has been shown in pre-clinical studies to increase the number of LDL receptors on hepatocytes, thereby lowering LDLc. 

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.

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