Sanofi and Regeneron to Present Results from Four Phase 3 Alirocumab

Paris, France, and Tarrytown, NY - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that details from four pivotal trials in the alirocumab ODYSSEY clinical program will be presented on Sunday, August 31, during a Hot Line session at ESC Congress 2014 in Barcelona, Spain, the world’s largest cardiology meeting. The data will also be highlighted in the official ESC press conference on August 31, at 09:00 CET.

Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). Top-line results from nine ODYSSEY Phase 3 trials were announced in late July 2014. The four trials that will be presented at ESC Congress 2014 include:

• ODYSSEY LONG-TERM – The 2,341-patient, double-blind trial is evaluating the long-term safety and efficacy of alirocumab versus placebo in combination with maximally tolerated lipid-lowering therapy, including statins, in patients with hypercholesterolemia who are at high cardiovascular (CV) risk.
• ODYSSEY COMBO II – The 720-patient, double-blind trial is evaluating the long-term safety and efficacy of alirocumab versus ezetimibe in combination with a maximally tolerated statin dose in high CV risk patients with hypercholesterolemia.
• ODYSSEY FH I and FH II – These trials involve a total of 738 patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH) and compare alirocumab to placebo in combination with maximally tolerated lipid-lowering therapy, including statins.

The data will be presented during three ESC Congress 2014 events:

• ESC CONGRESS 2014 HOT LINE PRESS CONFERENCE – Sunday, August 31, 09:00-10:00 CET
• CORONARY ARTERY DISEASE & LIPIDS HOT LINE SESSION II – Sunday, August 31, 16:30-18:00 CET
• ODYSSEY COMBO II study – C. Cannon (17:06 CET)
• ODYSSEY FH I and FH II studies – M. Farnier (17:12 CET)
• ODYSSEY LONG TERM study – J. Robinson (17:24 CE)
• MEET THE TRIALIST IV – Monday, September 1, 15:40-16:20 CET

Information on ESC Congress 2014 press conference, Hot Line session and Meet the Trialist session are currently available on the ESC website.

SANOFI AND REGENERON INVESTOR RELATIONS CONFERENCE CALL, Tuesday, September 2, 14:30-15:30 CET

• The companies will host an IR Thematic Conference Call for the financial community focusing on alirocumab. 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 44
UK +44 (0) 203 367 9453
U.S. +1 866 907 5928

Alirocumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

Source: Sanofi