Amarin Corp. (AMRN) is seeking approval for a label expansion of its drug Vascepa. Amarin is seeking 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 remind investors that the U.S. Food and Drug Administration (:FDA) accepted Amarin’s supplemental New Drug Application (sNDA) for the ANCHOR indication in Apr 2013.
Amarin had requested the FDA to reinstate the ANCHOR Special Protocol Assessment (SPA) agreement which is currently under consideration with the regulatory body. Consequently, the FDA did not take an action (PDUFA date – Dec 20, 2013) on Amarin's sNDA for the ANCHOR indication of Vascepa.
The FDA will now view Amarin's appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA separately. Amarin's request to reinstate the ANCHOR SPA agreement will be reviewed by FDA before Jan 15, 2014.
We note that Vascepa, the only marketed product of the company, is already 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 and. reported $8.4 million in sales of Vascepa in the third 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.
Amarin carries a Zacks Rank #3 (Hold). Investors may consider companies like Enanta Pharmaceuticals, Inc. (ENTA), Jazz Pharmaceuticals (JAZZ) and Questcor Pharmaceuticals Inc. (QCOR), all of which carry a Zacks Rank #1 (Strong Buy).