Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) presented new detailed positive results from six phase III ODYSSEY studies on alirocumab, a PCSK9 antibody. The candidate is being developed for the treatment of patients suffering from hypercholesterolemia. Detailed results from these studies were presented at the American Heart Association scientific sessions.
All six phase III ODYSSEY studies (ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH) met their primary efficacy endpoint of a greater reduction in low-density lipoprotein cholesterol (LDL-C) at 24 weeks, versus either the active comparator (including current standard of treatment) or placebo.
The ODYSSEY ALTERNATIVE study compared the use of alirocumab to Merck’s (MRK) Zetia (ezetimibe) in patients with high cardiovascular (CV) risk and history of intolerance to two or more statins. In the study it was found that patients in the alirocumab arm reported a 45% LDL cholesterol reduction compared to 15% in the Zetia arm.
Sanofi and Regeneron intend to submit regulatory filings for the candidate in the U.S. and EU by year end. The companies are looking to get priority review status for alirocumab in the U.S., which would shorten the standard review period of 10 months to six months.
We remind investors that Amgen Inc. (AMGN) has filed a lawsuit against Sanofi and Regeneron in the U.S. District Court of Delaware. Through this lawsuit, Amgen is looking to prevent the manufacture, use and sale of alirocumab (read more: Amgen Sues Sanofi and Regeneron over PCSK9 Candidate).
Amgen already submitted a Biologics License Application (BLA) seeking FDA approval for its PCSK9 inhibitor, evolocumab, for the treatment of high cholesterol on Aug 28, 2014. Amgen has been the first to submit a BLA for a PCSK9 inhibitor. We note that several other companies are also developing their own PCSK9 inhibitors.
Regeneron currently carries a Zacks Rank #4 (Sell) while Sanofi is a Zacks Rank #5 (Strong Sell) stock. Mylan (MYL) is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).
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