Amgen filed a lawsuit in the U.S. District Court of Delaware against Sanofi, Aventisub, formerly doing business as Aventis Pharmaceuticals (collectively “Sanofi”), and Regeneron Pharmaceuticals, claiming patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).

By its complaint, Amgen said it seeks an injunction to prevent the infringing manufacture, use, and sale of Sanofi and Regeneron's alirocumab, a mAB targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase III trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S.

Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on August 28.

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