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

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By Brendan Pierson

<span class="articleLocation”>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

“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.

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