Regeneron, Sanofi to
appeal U.S. judge's ban on cholesterol drug sales
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[January 06, 2017]
By Brendan Pierson
(Reuters) - Regeneron Pharmaceuticals Inc
and Sanofi SA said on Thursday they would appeal the U.S. District Court
ruling which banned the two companies from selling their cholesterol
drug, Praluent, on grounds of patent infringement.
A federal judge had earlier blocked Sanofi and Regeneron from
selling the drug after Amgen Inc accused them of infringing its
U.S. District Judge Sue Robinson in Delaware had ordered that the
ban not take effect for 30 days to give Sanofi and Regeneron time to
"It is our longstanding position that Amgen's patent claims are
invalid and that the best interests of patients will be greatly
disserved by an injunction preventing access to Praluent," Sanofi's
Executive Vice President Karen Linehan said in a statement.
Amgen was up about 4 percent in after-hours trading, while Sanofi's
U.S. shares were down 3.6 percent. Regeneron was down 1.1 percent
before the company requested that trading be halted.
Amgen had sought the ban 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
Thousand Oaks, California-based Amgen makes a rival drug called
A jury found Amgen's patents valid in March. The defendants said
after the verdict that they planned to appeal to the U.S. Federal
Circuit Court of Appeals, which reviews patent disputes.
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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Sales of the expensive new drugs, seen as potential blockbusters,
have been very slow to take off as health insurers and other payers
have been reluctant to pay for them. Amgen reported just $40 million
in Repatha sales in the third quarter.
Both drugs are in the final stages of enormous trials designed to
demonstrate that they can lower the risk of heart attacks and
deaths, which is expected to help open the insurer purse strings if
successful. So-called outcomes results for Repatha are expected this
"If Praluent was gone from the market the long-term peak sales for
Repatha could move from $2 billion to $3 billion to $4 billion
worldwide, in theory," RBC Capital Markets analyst Michael Yee said
in a research note. He added that without the outcomes results, the
potential size of the market remained uncertain.
(Reporting by Brendan Pierson in New York; additional reporting by
Bill Berkrot in New York and Nikhil Subba in Bengaluru; Editing by
Lisa Shumaker and Bill Rigby)
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