Sanofi and Regeneron Announce 18,000-Patient ODYSSEY OUTCOMES Trial of Praluent® (alirocumab) Injection Fully Enrolled

Paris and Tarrytown, New York - November 24, 2015 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the companies have completed enrollment in the global Phase 3 ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential cardiovascular (CV) benefits of Praluent ® (alirocumab) Injection after an acute coronary syndrome (ACS). The 18,000-patient ODYSSEY OUTCOMES trial is expected to be completed in 2017.

ODYSSEY OUTCOMES is designed to determine whether the addition of Praluent to intensive statin therapy reduces major adverse cardiac events among patients who had previously experienced an ACS, such as a heart attack or unstable angina. The primary endpoint evaluates the time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or fatal and non-fatal ischemic stroke. Patients with recent ACS were selected as the study population because they face a higher risk of recurrent events than patients with stable cardiovascular disease.

Praluent is currently approved in the U.S. and EU to reduce bad (LDL) cholesterol in some patients with significant unmet need, including those with established cardiovascular disease, or an inherited form of high cholesterol, called heterozygous familial hypercholesterolemia (HeFH). The effect of Praluent on CV morbidity and mortality has not been determined.

The global ODYSSEY program includes 16 Phase 3 trials conducted at more than 2,000 study centers, around the world, and once complete will evaluate more than 25,000 patients. Data from this program helped form one of the most comprehensive data sets ever used for the initial regulatory filing of a cholesterol-lowering therapy. In completed trials, Praluent reduced LDL cholesterol by up to an additional 62 percent versus placebo, and was generally well-tolerated with an acceptable safety profile.

The ODYSSEY OUTCOMES trial design was published in the American Heart Journal in November 2014.

About Praluent
In July, the companies announced that Praluent was approved for use in the U.S. Praluent is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CVD, who require additional lowering of LDL cholesterol. The effect of Praluent on CV morbidity and mortality has not been determined.

In September, the European Commission approved the marketing authorization for Praluent. In the E.U., Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on CV morbidity and mortality has not yet been determined.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Important Safety Information for U.S.
Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT.
Before you start using PRALUENT, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.

The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Talk to your doctor about the right way to prepare and give yourself a PRALUENT injection and follow the "Instructions for Use" that comes with Praluent.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit  www.fda.gov/medwatch  or call 1-800-FDA-1088.

Please click  here  for the full Prescribing Information

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

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN ) 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 commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

Contacts Sanofi:

Global Communications, PCSK9 Development & Launch Unit
Elizabeth Baxter                                               
Tel: +1 (908) 981.5360
Mobile: +1 (908) 340-7811         
Elizabeth.Baxter@sanofi.com

Contacts Regeneron: