Amarin Sinks to Five-Month Low After Losing Ruling on Heart Drug

(Bloomberg) -- Amarin Corp. fell to the lowest since March after it lost its bid to revive patents on the heart medicine Vascepa, its only product, a decision that opens the door to generic competition for the drug.

The U.S. Court of Appeals for the Federal Circuit in Washington affirmed a trial court ruling that invalidated six patents on Vascepa. The decision, made without a formal opinion, came just one day after the court heard arguments in the case.

Amarin closed down 9.5% in New York trading of 47 million shares, seven times the daily average. The stock has shed more than three-quarters of its value this year and sank 31% on Wednesday after tough questioning from the U.S. appeals court.

Vascepa, a synthetic version of fish oil that’s used to lower triglyceride levels, accounted for almost all of Amarin’s $429.8 million in revenue last year. Analysts had projected that sales of the therapy could reach over $1 billion by next year. Amarin had been counting on the patents to block generic competition until 2030.

Amarin said it was “extremely disappointed” in the ruling. Chief Executive Officer John Thero said the company is pursuing additional regulatory approvals for the drug in China, Europe and the Middle East and “will continue to meet the strong demand for Vascepa here in the United States through our proven manufacturing capabilities.”

Not That Unique

Amarin, based in Dublin, also said it will ask the panel to reconsider its decision or petition for the case to be heard before all active judges in the court. Those requests are rarely granted, though, particularly if the original panel believed the case was so cut-and-dried that it affirmed the trial court without an opinion.

Generic-drug makers Dr. Reddy’s Laboratories Ltd. and Hikma Pharmaceuticals successfully argued that a version of Vascepa’s active ingredient has been known since the 1990s, so the treatment method isn’t all that unique.

Hikma said it received U.S. Food and Drug Administration approval for its generic version and “is working towards a launch.”

Amarin argued that Vascepa is a “major advance” against high triglycerides and eliminated some of the negative risks associated with other medicines, such as increasing levels of so-called bad cholesterol, a wasting of muscle, and gastrointestinal problems.

Investors had bet that Amarin would lose the appeal after the three-judge panel on Wednesday subjected Amarin’s lawyers to tough questioning but not the lawyers representing the generic-drug makers.

The case is Amarin Pharma v. Hikma Pharmaceuticals USA, 20-1723, U.S. Court of Appeals for the Federal Circuit (Washington).

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