Amgen files US suit claiming Sanofi, Regeneron's PCSK9 inhibitor alirocumab infringes patents

Amgen said Friday that it filed a lawsuit in the US District Court of Delaware claiming that Sanofi and Regeneron Pharmaceuticals' PCSK9 inhibitor alirocumab infringes several of the company's patents. According to Amgen, the patents affected describe and claim monoclonal antibodies to PCSK9. The lawsuit seeks an injunction to block the manufacture, use and sale of alirocumab.

Sanofi and Regeneron said in July that they plan to seek US and EU approval of alirocumab by the end of the year after reporting that nine Phase III studies of the therapy in people with hypercholesterolaemia met their primary endpoint of significantly reducing LDL cholesterol versus placebo or active comparator. The companies later purchased a priority review voucher from BioMarin Pharmaceutical to speed the FDA's assessment of the submission (for related analysis, see ViewPoints: But what is an FDA priority review voucher actually worth? BioMarin finally puts a price tag on it).

Meanwhile, Amgen has submitted filing for its PCSK9 inhibitor evolocumab for the treatment of high cholesterol in the US and EU. For related analysis on the PCSK9 inhibitor class, see Physician Views Poll Results: Lack of outcomes data, negative IMPROVE-IT results will limit PCSK9 inhibitor use; less frequent dosing seen as offering minimal advantage, and Spotlight On: With PCSK9 mAbs knocking on the door, all eyes will soon turn to Merck & Co.'s IMPROVE-IT study.

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