Amgen Inc (AMGN) has filed a lawsuit against Sanofi (SNY ) and Regeneron Pharmaceuticals, Inc. (REGN) in the U.S. District Court of Delaware. The lawsuit is related to the infringement of certain patents (patent numbers 8,563,698, 8,829,165, and 8,859,741) owned by Amgen which describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).
Sanofi and Regeneron are jointly developing alirocumab (proposed trade name: Poluent), a PCSK9 antibody. The candidate is being developed for the treatment of patients suffering from hypercholesterolemia. Through this lawsuit, Amgen is looking to prevent the manufacture, use and sale of alirocumab.
Sanofi and Regeneron have completed phase III studies on alirocumab and intend to submit regulatory filings for the candidate in the U.S. 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.
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We note that Amgen has 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. Although Amgen is the first to submit a BLA for a PCSK9 inhibitor, Sanofi and Regeneron with alirocumab are not far behind.
In this race, it will be a huge win for Amgen if the court rules in its favor. We note that Pfizer Inc. (PFE) is also developing its own PCSK9 inhibitor, bococizumab, which is currently being evaluated in phase III studies.
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Regeneron (REGN) and partner Sanofi are facing a patent infringement lawsuit from Amgen regarding their PCSK9 inhibitor, alirocumab. Through this lawsuit, Amgen is trying to delay the entry of competitors in the highly lucrative cholesterol management market. Amgen has been ahead in the race having filed for approval of its PCSK9 inhibitor, evolocumab, this August.
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