Sanofi and Regeneron sued over cholesterol-regulating antibodies

The US biopharmaceutical company Amgen has filed a patent infringement lawsuit against Sanofi and Regeneron in the US District Court of Delaware. The suit claims the companies are infringing Amgen’s patents on monoclonal antibodies (mAbs) to proprotein convertase subtilisin/kexin type 9 (PCSK9).

Specifically, the company seeks an injunction related to its PCSK9 inhibitor used to lower cholesterol levels. Amgen wants to prevent Sanofi and Regeneron from manufacturing, using and selling alirocumab – a mAb targeting PCSK9. ‘The claims [in the patents] are directed to monoclonal antibodies to PCSK9 with specific characteristics,’ Amgen’s Kristen Davis tells Chemistry World.

In August, Sanofi and Regeneron presented results from Phase III clinical trials on alirocumab and said they intended to pursue regulatory approval to market the product in the US. The companies will be making use of a Food and Drugs Administration (FDA) Priority Review voucher (bought from BioMarin) to cut the review timeline to six months instead of 10.

At the end of August, Amgen filed for FDA approval for evolocumab - its own investigational antibody to PCSK9 - but without Priority Review. That means Sanofi and Regeneron’s drug could potentially be approved before Amgen’s, unless the court grants the injunction.