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FDA Not in Favor of Amarin's Vascepa

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The U.S. Food and Drug Administration’s (:FDA) Endocrinologic and Metabolic Drugs Advisory Committee dealt a blow to Amarin Corporation (AMRN) with the panel voting 9 to 2 against granting approval to the company’s Vascepa capsule for an additional indication.

Amarin  is looking to get Vascepa approved as an adjunct to diet and exercise and in combination with a statin for treating adults with high triglyceride levels (≥200 mg/dL and <500 mg/dL) with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent. Amarin refers to this as the ANCHOR indication.

We note that in Apr 2013, the FDA accepted the supplemental New Drug Application (sNDA) for the ANCHOR indication. A response from the FDA should be out by Dec 20, 2013.

We note that Vascepa, the only marketed product of the company, is currently approved in the U.S. as an adjunct to diet for reducing triglyceride levels in adults suffering from severe hypertriglyceridemia (triglyceride ≥ 500mg/dL). Amarin refers to this as the MARINE indication. Amarin started marketing the drug in the U.S. in Jan 2013. Amarin reported $5.5 million sales of Vascepa in the second quarter of 2013.

Amarin is leaving no stone unturned to successfully commercialize Vascepa (MARINE indication) and expand the drug’s label into the ANCHOR indication.

In Sep 2013, Amarin announced that its cardiovascular outcomes study, REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial), has enrolled more than 6,000 patients. The study, which commenced in Dec 2011, is evaluating Vascepa’s safety and efficacy as an adjunct to statin therapy in reducing first major cardiovascular events in a high risk patient population.

In Jul 2013, Amarin had raised approximately $121.1 million (net) through the issuance of 21.7 million American Depository Shares. The company is using the funds for the ongoing launch of Vascepa and also for advancing the REDUCE-IT study.

Amarin carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) and Endo Health Solutions Inc. (ENDP) with a Zacks Rank #1 (Strong Buy), and Alexion Pharmaceuticals, Inc. (ALXN) with a Zacks Rank #2 (Buy).

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