Regeneron, Sanofi Win Stay of Order Banning Cholesterol Drug Sales

Regeneron/Sanofi will continue marketing, manufacturing, and selling alirocumab.

Regeneron and Sanofi will continue marketing, manufacturing, and selling their PCSK9 inhibitor alirocumab (Praluent) in the United States after the US Court of Appeals for the Federal Circuit today suspended a lower court's injunction.

In January, in a patent dispute, a judge had said the Regeneron had violated a patent held by its rival, Amgen's is evolocumab, marketed as Repatha. Sanofi/Regeneron's is alirocumab, marketed as Praluent.

The two pharmaceutical companies dispute that court's finding and say Amgen’s January victory over patent claims for antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) are invalid.

Praluent was the first PCSK9 inhibitor approved in the US indicated to use in addition to diet and maximally tolerated statin therapy for the adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require reduced "bad" (LDL) cholesterol. It is also prescribed for people who cannot take statins, or for whom statins do not work.

In issuing the stay the US Court of Appeals judges said, “Our determination is governed by four factors, the first two of which are the most critical: (1) whether the movant has made a strong showing of likelihood of success on the merits; (2) whether the movant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.”

Officials explained that the injunction is not applicable outside the US or to clinical trials, which are continuing as planned. Outside the US, Praluent is marketed and sold in 15 countries salted to launch in 15 additional countries in 2017.