Biotech News: Amarin Stock Plummets after the FDA Denies Major Appeal

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Amarin Corporation (AMRN) tumbled 17.7% after the company announced that the FDA’s Office of New Drugs (OND) denied the company’s appeal regarding the rescission of the Special Protocol Assessment (SPA) covering the phase III ANCHOR study on Vascepa.

Vascepa has been available in the U.S. since Jan 2013 as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Amarin is looking to get Vascepa approved for the treatment of patients with high triglyceride levels (≥ 200 mg/dL and <500 mg/dL) who are also on statin therapy for elevated low-density lipoprotein cholesterol levels. The company had submitted the marketing application for this indication based on encouraging data from the ANCHOR study in Apr 2013. However, the FDA rescinded the SPA agreement in Oct 2013 as it identified a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population after testing began. Amarin appealed the decision.

In Jan 2014, the Division of Metabolism and Endocrinology Products (DEMP) declined to re-instate the ANCHOR SPA agreement, which the Office of Drug Evaluation II upheld in Apr 2014.

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Amarin is evaluating its next steps. We note that Amarin had stated previously that it would be difficult to achieve a SPA agreement reinstatement. The company believes that in order to get Vascepa approved for the additional indication, it will have to furnish the FDA with data from a cardiovascular outcomes study (REDUCE-IT).

However, the anticipated aggregate cost to complete the REDUCE-IT (excluding amounts already incurred) is more than $100 million and the study may take a few years to complete.

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Vascepa generated sales of $23.6 million in the first half of 2014. Earlier this year, the company entered into a co-promotion agreement with Kowa Pharmaceuticals America, Inc.

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