A ruling on Amarin Corp. (AMRN)’s application to expand use of its fish-oil pill was delayed by the Food and Drug Administration as the agency considers the company’s appeal of a requirement for more study on the drug.
A decision scheduled for today was postponed indefinitely as the FDA looks at Amarin’s appeal of a decision that the company conduct a trial showing whether the product, Vascepa, improves cardiovascular outcomes, the Dublin-based drugmaker said today in a statement. Amarin rose 25 percent to $2 at the close in New York, its biggest gain since April 2011.
The delay isn’t necessarily a sign the drug will be cleared for the expanded use, said Akiva Felt, an analyst with Oppenheimer & Co., who expects a rejection by the FDA.
“Given the low expectations for approval and the fact that Amarin now has a window to at least present their case to FDA, it’s not too surprising to see the stock moving higher,” Felt said in an e-mail.
The FDA approved the prescription-grade omega-3 fatty acid last year to treat severe triglycerides, a measure of fat in the blood. Expanding use of the pill, Amarin’s only product, to less seriously ill patients who have elevated triglycerides would give the drugmaker access to 36 million U.S. customers, or nine times the pool of people with very high levels.
The pill may generate $28 million in sales this year, according to the average of six analysts’ estimates compiled by Bloomberg.
Amarin said on Dec. 16 that John Thero, the company’s current president, will become chief effective officer on Jan. 1, succeeding Joseph Zakrzewksi, who will retire.
The FDA agreed with Amarin in 2008 that the company needed to have the cardiovascular outcomes trial under way, not completed, when it sought approval for people with high triglycerides. The agency rescinded the accord Oct. 29 based on recent clinical trials and meta-analyses that have failed to confirm a heart benefit from lowering lipids.
Amarin said today that the FDA will relay its decision on the appeal by Jan. 15. The regulator hasn’t indicated when it will rule on the application to expand use of the drug, the company said.
Triglycerides and cholesterol are separate types of lipids, or fat in the blood, according to the Mayo Clinic.
Amarin, run from Bedminster, New Jersey, sought approval for the drug to treat patients with high triglycerides who also are taking cholesterol-lowering statins.
GlaxoSmithKline Plc (GSK)’s fish oil pill Lovaza was approved in 2004 for patients with very high triglycerides. Very high triglyceride levels measure at least 500 milligrams per deciliter. High triglycerides are those from 200 milligrams to 500 milligrams per deciliter.
Stores such as GNC Holdings Inc. (GNC) and Vitamin Shoppe Inc. (VSI) sell non-prescription dietary supplements containing fish oil. It would take 10 to 40 of such omega-3 capsules to equal the pure fatty acid obtained from “wild deep-water Pacific Ocean fish,” according to the company’s website for Vascepa.
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