Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9

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A Priority Review voucher Sanofi and Regeneron purchased from BioMarin pharmaceuticals may put their mAb ahead of Amgen's in the market.

Amgen announced on Oct. 17, 2014 it is suing Sanofi and Regeneron to prevent the allegedly infringing manufacture, use, and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody (mAb) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). A version of the mAb is being developed by both companies to treat hypercholesterolemia, a condition that causes high levels of low-density lipoprotein cholesterol in the blood. PCSK9 helps to maintain cholesterol homeostasis.

Sanofi and Regeneron recently announced that they have completed Phase III clinical trials on alirocumab, and with the help of a Priority Review voucher they purchased for $67.5 million from BioMarin Pharmaceutical Inc., their mAb product would have a six-month review, putting it ahead of Amgen’s mAb review by four months. Even though Amgen filed three patents for a mAb targeting PCSK9 first, on Aug. 28, 2014, Amgen’s product would be subject to the standard review, which lasts 10 months.

According to BioCentury, BioMarin gained the voucher to expedite as a result of the approval of Vimizim (elosulfase alfa) to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome) under FDA's Rare Pediatric Disease Review Voucher program.