Regeneron, Sanofi win stay of U.S. order blocking cholesterol drug sales

[February 09, 2017]  By Brendan Pierson

(Reuters) - A U.S. appeals court on Wednesday stayed an order that would have blocked Regeneron Pharmaceuticals Inc and Sanofi SA from selling their cholesterol drug, Praluent, while they appeal the order.

A federal judge earlier had blocked sales of the drug after rival Amgen Inc won a trial in which it accused them of infringing its patents. The order would have taken effect on Feb. 21.

Regeneron general counsel Joseph LaRosa said in a statement the company would continue to defend its case through the appeal process.

"We continue to believe the facts and controlling law support our position in this case,” he said.

Sanofi spokeswoman Ashleigh Koss said in an email the company was pleased the order had been stayed, "giving patients in the U.S. continued access to this important medicine during the appeal process.

"It is our longstanding position that Amgen’s asserted patent claims are invalid," she said.

Amgen spokeswoman Kristen Davis said in an email that the company respected the court's decision but was confident it would prevail against Regeneron and Sanofi's appeal.

Amgen was down 1.9 percent in after-hours trading. Regeneron was up 2.7 percent in after-hours trading and U.S.-traded shares of Sanofi were down 1.9 percent.

Amgen had sought to block Praluent sales in an October 2014 lawsuit against Paris-based Sanofi and Tarrytown, New York-based Regeneron. It said Praluent, a drug intended to lower "bad" LDL cholesterol by blocking a protein known as PCSK9, infringed its patents related to the protein.

Thousand Oaks, California-based Amgen makes a rival drug called Repatha.

A jury found Amgen's patents valid last March. U.S. District Judge Sue Robinson in Delaware, who presided over the case, granted a motion last month by Amgen to bar sales of Praluent.

Regeneron and Sanofi petitioned the U.S. Court of Appeals for the Federal Circuit to stay that order while they appealed. Multiple doctors submitted briefs in support of a stay, saying patients would be harmed if sales of Praluent were halted.

The companies could still decide to reach a settlement that would give Amgen royalties on Praluent sales.

The U.S. Food and Drug Administration approved Praluent and Repatha to reduce bad cholesterol in 2015. The drugs are more costly than other cholesterol drugs, with a list price topping $14,000 annually.

(Reporting by Brendan Pierson in New York; Editing by Leslie Adler and Lisa Shumaker)

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