Amarin Plunges After Vascepa Patents Are Invalidated

(Bloomberg) -- Amarin Corp. plunged in after-hours trading after a U.S. judge invalidated its patents on the heart treatment Vascepa, opening the door to low-cost versions of a drug that accounts for almost all of its revenue.

Amarin pledged to appeal.

Six patents on the drug, which all expire in 2030, are invalid, said District Court Judge Miranda Du in Las Vegas. The judge’s decision was posted on the court’s electronic docket. Amarin, which closed at $13.58 in New York trading, fell more than 70% -- as low as $3.92 -- after the close of regular trading.

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. The medicine recently secured a broader label related to its cardiovascular benefits from the Food and Drug Administration. Sales of the therapy could reach over $1 billion by next year, according to analysts tracked by Bloomberg.

The drug, whose active ingredient is icosapent ethyl, works to lower triglyceride levels, which can lead to strokes and deadly pancreatitis. The patents cover methods of using a purified form of the compound over the course of 12 weeks.

“Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the court’s decision,” Amarin Chief Executive Officer John Thero said in a statement. He said the company would seek a court order that would prevent generic-drug makers from entering the market until the appeal is decided.

Competitors are unlikely to get to the market before at least next year, according to Jefferies analyst Michael Yee’s calculations.

There are no approved generics waiting in the wings that Amarin or the analyst is aware of. It’s unlikely any of the drug makers had stockpiled product before the decision, given the uncertainties ahead of the ruling, Yee wrote to clients in a note that warned of “very rough waters” for the company.

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

“We are very pleased with the court’s decision and are working diligently to gain the FDA’s approval of our application so we can provide patients with a generic version of this important medicine,” said Steve Weiss, a Hikma spokesman.

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.

Du ruled that the “long-felt need” for a drug that would lower triglycerides without raising bad cholesterol in a single pill and the commercial success of Vascepa weren’t enough to overcome her finding that the patents were an obvious variation of earlier know-how.

The generic-drug makers lost their argument that their labeling wouldn’t cover the patented treatment methods, and they shouldn’t be liable if doctors, on their own, tell patients to take the drug over 12 weeks. That issue would become important if an appeals court later revives the patents.

The case is Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., 16-2525, U.S. District Court for the District of Nevada (Las Vegas).

©2020 Bloomberg L.P.