Amarin Corp. (AMRN) lost more than half its value after the company failed to win the backing of U.S. advisers to expand use of its fish-oil pill Vascepa for those with high levels of fat in their blood.
Amarin’s American depositary receipts fell 61 percent to $2.01 at 4 p.m. New York time, their biggest loss since April 2007. Amarin had already dropped 54 percent in the 12 months through Oct. 15. Trading was halted yesterday during the advisory panel meeting.
The Food and Drug Administration panel voted 9-2 yesterday that Amarin should complete a study on the drug’s ability to benefit the heart before an approval decision for patients with high triglycerides. The FDA is scheduled to decide whether to clear the drug for wider use by Dec. 20.
“Let’s see the results in an outcomes trial,” Peter Wilson, a panel member and professor at Emory University’s School of Medicine in Atlanta, said during the meeting. “That’s really where the proof is, in the pudding, in my view.”
The agency doesn’t have to follow the panel’s advice. The FDA had cleared the prescription-grade omega-3 fatty acid last year to treat “very high” triglycerides, a measure of fat in the blood.
Expanded approval would give Dublin-based Amarin access to 36 million potential U.S. customers who have elevated triglycerides, or nine times the pool of people with severely high levels. The company is seeking to treat high triglyceride patients on statin therapy who have low levels of good cholesterol and coronary heart disease.
FDA staff members questioned Oct. 11 whether Vascepa’s lipid-lowering effects were sufficient to move ahead with approval based on recent clinical trials and meta-analyses that have failed to confirm a heart benefit from the lipid lowering. Triglycerides and cholesterol are separate types of lipids, or fat in the blood, according to the Mayo Clinic.
Amarin, run from Bedminster, New Jersey, declined 20 percent Oct. 11 after the release of the staff’s report, the biggest drop for the company’s ADRs in more than three years.
The FDA originally agreed with Amarin in 2008 that the company needed only to have the cardiovascular outcomes trial under way, not completed, when it sought approval for people with high triglycerides.
“The critical question which patients care about is, ultimately, will the observed changes in lipids/lipoproteins with Vascepa treatment in statin-treated patients translate into a benefit on cardiovascular outcomes,” Mary Roberts, a medical officer at FDA, said during the meeting. “This question is not new, but now we have more data.”
Amarin is studying Vascepa’s ability to reduce cardiovascular events.
The company estimates key costs of $30 million to $40 million this year related to the study and “costs continue to be fairly significant for a good portion of next year,” President John Thero, said on a conference call yesterday after the panel meeting. Amarin expects to complete enrollment of 8,000 patients in 2015 and finish the trial in 2017, he said.
An interim analysis of the trial could happen near the end of 2015, Steven Ketchum, president of research and development at Amarin, said on the call.
Sales of Vascepa, the company’s sole product, may reach $1.2 billion in 2017, according to the average of five analysts’ estimates compiled by Bloomberg. The company’s revenue is estimated to total $36 million this year.
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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