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

PARIS and TARRYTOWN, N.Y. -- Sanofi and Regeneron Pharmaceuticals, Inc. 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:

•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. ezetimibe in patients not receiving statin or other lipid-lowering therapies

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

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 ezetimibe or fenofibrate over a four week dosing interval

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 

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)

Catherine Lunven – Sanofi, Paris, France

Source: Regeneron Pharmaceuticals, Inc.