3 November 2014Americas

Amgen sues Sanofi over cholesterol drug

Biotechnology company Amgen has filed a lawsuit against Sanofi and Regeneron Pharmaceuticals accusing the pair of infringing three patents.

In the lawsuit, filed at the US District Court for the District of Delaware on October 28, Amgen has accused the companies of infringing its patents by creating an antibody that blocks the protein PCSK9, helping to treat cholesterol related disorders as a result.

The lawsuit seeks to prevent the manufacture, use and sale of Sanofi and Regeneron's alirocumab, a drug they are producing together, on the grounds that is too similar to Amgen’s own evolocumab.

According to the Fierce Biotech news website, the lawsuit is the latest development in an “increasingly contentious” race between the companies, all of which are attempting to be the market leader for new cholesterol-lowering drugs.

Amgen asked the US Food and Drug Administration (FDA) in August this to approve evolocumab, aiming for a 2015 launch.

According to the complaint, earlier this summer Sanofi and Regeneron, which have partnered together, paid the FDA $67.5 million for a special priority review voucher to cut the review time from 10 months to six months for their alirocumab drug.

In a statement announcing the lawsuit, Amgen said it was seeking an injunction to “prevent the infringing manufacture, use and sale” of alirocumab.

“Amgen will be substantially and irreparably harmed if defendants are not enjoined from infringing the patent[s],” it said in the complaint.

“Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on August 28, 2014,” it added.

Sanofi and Regeneron did not immediately respond to a request for comment.

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