INVESTORS & MEDIA
News Release
Regeneron and Sanofi to Present Results from Four Phase 3 Alirocumab Trials in Hot Line Session at ESC Congress 2014
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
- 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 2014Hot Line Press Conference -Sunday, August 31 ,09:00-10:00 CET /03:00-04:00 ET - CORONARY ARTERY DISEASE & LIPIDS Hot
Line Session II -Sunday, August 31 ,16:30-18:00 CET /10:30-12:00 ET - ODYSSEY COMBO II study -
C. Cannon (17:06 CET /11:06 ET ) - ODYSSEY FH I and FH II studies - M. Farnier (
17:12 CET /11:12 ET ) - ODYSSEY LONG TERM study -
J. Robinson (17:24 CET /11:24 ET )
- ODYSSEY COMBO II study -
- Meet the Trialist IV -
Monday, September 1 ,15:40-16:20 CET /9:40-10:20 ET
Information on the
SANOFI AND REGENERON Investor Relations Conference Call, Tuesday,
- 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 44UK +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.
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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, such as the ODYSSEY global trial program evaluating alirocumab; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, including without limitation alirocumab; 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
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