Back to top

Analyst Blog

Amarin Corp. (AMRN - Snapshot Report) 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 - Snapshot Report), Jazz Pharmaceuticals (JAZZ - Analyst Report) and Questcor Pharmaceuticals Inc. , all of which carry a Zacks Rank #1 (Strong Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
SUPER MICRO… SMCI 26.62 +8.70%
CENTURY ALU… CENX 27.09 +8.45%
BANCO DO BR… BDORY 16.68 +7.41%
CANADIAN SO… CSIQ 37.85 +6.80%
WILLDAN GRO… WLDN 11.37 +5.77%