Judge Won't Stay Injunction of Praluent Sales During Appeal

A federal judge said Monday that Sanofi and Regeneron cannot sell the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Praluent (alirocumab) during their appeal of her earlier ruling in a patent dispute. Barring a settlement or a reversal, the drug makers could be forced to stop selling the cholesterol-fighting drug within 6 weeks.

US District Judge Sue Robinson issued an order Thursday that Sanofi and Regeneron must pull Praluent from the market for 12 years, following a March 2016 jury finding that the companies violated Amgen’s patents for Repatha (evolocumab). Amgen announced Monday’s ruling, in which Robinson extended the start of her injunction barring Praluent sales from 30 to 45 days.

The high-profile case could mean that Amgen would control the US market for the powerful PCSK9 inhibitors, which dramatically reduce low-density lipoprotein (LDL) cholesterol by targeting a protein in the liver.

The rival drugs were approved in July (Praluent) and August (Repatha) of 2015 after a fierce battle to be the first to the market. Sanofi paid for a priority review voucher to jump ahead of Amgen in the FDA queue. Both drugs had initial wholesale prices above $14,000, which prompted payers and pharmacy benefit managers to implement strict protocols for who could gain access.

“Amgen respects the court’s thoughtful deliberations in a situation where a competitor made the choice to launch at risk during the pendency of a patent lawsuit within months of an expedited trial date,” the company said in its statement.

Sanofi and Regeneron, meanwhile, said in a statement they will take their case to the US Circuit Court of Appeals. Regeneron CEO Len Schleifer told attendees at the JP Morgan Healthcare Conference that he was surprised by Amgen’s push for the injunction, and as well as Amgen’s position that “they have to take these products from patients and disrupt it right now. I just don’t think that’s in the interest of the patients, the judge doesn’t think that was in the interest of the public, and I just think that’s a mistake,” Schleifer said.