Expanding the use of Amarin Corp. (AMRN:US)’s fish oil drug Vascepa, approved last year to treat “very high” triglycerides, may depend on the outcome of a study on heart risks, U.S. regulators said.
Amarin declined (AMRN:US) 20 percent after Food and Drug Administration workers today gave an assessment of the prescription-grade omega-3 fatty acid in a report. An FDA advisory panel is set to meet Oct. 16 to discuss expanded approval for the drug to people with only high triglycerides, a fat in the blood, who also are using a cholesterol-lowering statin therapy.
The company, based in Dublin and run from Bedminster, New Jersey, is studying Vascepa’s ability to reduce cardiovascular events, the results of which probably won’t be available until 2016, Steve Ketchum, president of research and development, said Aug. 8 on a conference call. Next week’s advisory panel discussion is likely to be heated and the vote close, said Akiva Felt, an analyst with Oppenheimer & Co. in San Francisco.
“The hope for the best-case scenario, that the panel is really a formality, is off the table,” Felt, who has a “market perform” rating on the stock, said by phone. “The FDA does appear to be a little more cautious on the drug’s efficacy.”
Vascepa is Amarin’s lone product. The FDA approved the drug in July 2012 for people with very high triglycerides, a measure of fat in the blood of at least 500 milligrams per deciliter. The agency was scheduled to decide by Dec. 20 whether to clear the drug for people with high triglycerides, a level of 200 milligrams to 500 milligrams per deciliter.
A decision to await the further data would push Amarin back by three to four years, Felt said. Expanded approval would give Amarin access to 36 million potential customers in the U.S. who have elevated triglycerides, or nine times the existing pool of people with severely high triglyceride levels.
Sales of Vascepa are supposed to reach $932 million in 2017, according to the average of six analysts’ estimates (AMRN:US) compiled by Bloomberg.
Amarin’s American depositary receipts fell to $5.09 at the close in New York, their biggest one-day drop since January 2010. The company has decreased (AMRN:US) 37 percent this year.
Vascepa may be the first in its class of drugs to gain FDA approval for high triglycerides. GlaxoSmithKline Plc’s fish oil pill Lovaza was approved in 2004 for patients with very high triglycerides. Vascepa doesn’t raise bad cholesterol levels while there is a possibility of increased levels with Lovaza.
Stores such as GNC Holdings Inc (GNC:US). and Vitamin Shoppe Inc (VSI:US). 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.
Amarin sought “new chemical entity” status that would afford the company as much as five years of exclusivity to sell the drug without generic competition. While Amarin expected the FDA to determine whether it would grant Vascepa the designation reserved for innovative drugs and new uses of approved treatment, the agency has yet to act. The FDA published a draft guidance in April for companies that may want to create a generic version of Vascepa.
Prescriptions for Vascepa totaled 47,300 in the second quarter from April through June, generating sales of $5.5 million, Amarin Chief Executive Officer Joseph Zakrzewski, said on an Aug. 8 conference call (AMRN:US). Amarin tried to find a buyer or enter into a partnership with another company to sell Vascepa and ended up hiring its own sales force when the drug reached the market at the beginning of this year.
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