Amgen beats Sanofi, Regeneron at chol...
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Amgen beats Sanofi, Regeneron at cholesterol drug trial
Pharma News

federal jury upheld the validity of two Amgen Inc patents related to the company’s newly-approved drug to reduce bad cholesterol, in a defeat for Sanofi SA and Regeneron Pharmaceuticals Inc, which make a rival drug.

In a joint statement on Wednesday, Sanofi and Regeneron said they strongly disagreed with the verdict by jurors in Wilmington, Delaware upholding the validity of Amgen’s patents, which followed a weeklong trial.

Damages have yet to be set. The defendants said they plan to appeal to the U.S. Federal Circuit Court of Appeals, which reviews patent disputes.

In its October 2014 lawsuit, Amgen sought to stop Paris-based Sanofi and Tarrytown, New York-based Regeneron from selling Praluent, a drug intended to lower bad LDL cholesterol by blocking a protein known as PCSK9.

Amgen makes a rival drug called Repatha, and said Praluent infringed the Thousand Oaks, California-based company’s patents related to the protein.

Last summer, the U.S. Food and Drug Administration approved Praluent and Repatha to reduce bad cholesterol.

U.S. District Judge Sue Robinson, who presided over the trial, is expected to consider whether to issue a permanent injunction against the sale of Praluent.

Sanofi and Regeneron said the verdict will not keep them from selling Praluent for now.

But they may owe royalties to Amgen if the litigation, following any appeals, ultimately concludes in Amgen’s favor.

Amgen in a statement said it was “thankful” for the verdict.

The drugs are costlier than other treatments targeting bad cholesterol, with a list price topping $14,000 annually.

Sales have been slow because insurers have resisted the cost, while many doctors are awaiting the results of clinical trials about whether the treatments also reduce the risk of heart attacks and strokes.

“A permanent injunction is unlikely,” Deutsche Bank analyst Tim Race said in a research note. “However, the likelihood of settlement has now increased substantially with Sanofi and its partner Regeneron potentially forced to pay royalties.”

In afternoon trading, Amgen shares were up 70 cents at $143.91; Regeneron shares were down $2.83 at $364.39; and Sanofi’s American depositary shares were down 32 cents at $40.83.

Courtesy – Reuters

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