Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) announced that the Marketing Authorisation Application for their PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody, Praluent, has been accepted by the European Medicines Agency. The companies are looking to get the candidate approved for the treatment of patients suffering from hypercholesterolemia.
We remind investors that a biologics license application (BLA) for Praluent was submitted to the FDA in the fourth quarter of 2014.
Meanwhile, in a separate press release, Regeneron and Sanofi announced encouraging data on Praluent from two phase III ODYSSEY (ODYSSEY CHOICE I and CHOICE II) studies. The studies compared the use of Praluent administered every four weeks versus placebo in patients with hypercholesterolemia.
While ODYSSEY CHOICE I assessed the efficacy and safety of Praluent in patients with hypercholesterolemia at moderate-to-high cardiovascular (CV) risk, ODYSSEY CHOICE II evaluated Praluent in patients with hypercholesterolemia with high CV risk and/or a history of intolerance to two or more statins. Both the studies met the primary endpoint.
We remind investors that Amgen Inc. (AMGN) has filed a lawsuit against Sanofi and Regeneron in the U.S. District Court of Delaware. Amgen through this lawsuit is looking to prevent the manufacture, use and sale of Praluent (read more: Amgen Sues Sanofi and Regeneron over PCSK9 Candidate).
Amgen submitted a BLA seeking FDA approval for its PCSK9 inhibitor, evolocumab, for the treatment of high cholesterol on Aug 28, 2014. Amgen was 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 #3 (Hold) while Sanofi is a Zacks Rank #4 (Sell) stock. Alexion Pharmaceuticals, Inc. (ALXN) is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).
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