Regeneron, Sanofi to appeal US judge’s ban on cholesterol drug sales

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By Brendan Pierson

<span class="articleLocation”>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 patents.

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 appeal.

“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 protein.

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

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.

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 quarter.

“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. (Additional reporting by Bill Berkrot in New York and Nikhil
Subba in Bengaluru)



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