Amarin's Vascepa Gets 3-Year Exclusivity - Analyst Blog

Shutterstock photo

Amarin Corporation plc ( AMRN ) announced that Vascepa was given three years of marketing exclusivity by the U.S. Food and Drug Administration (FDA) in connection with the MARINE indication.

We note that Vascepa 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.

The exclusivity runs through Jul 25, 2015 plus a 30-month period that may be triggered if any company files an Abbreviated New Drug Application (ANDA) and Amarin in turn files a patent infringement lawsuit within the specified time period.

Amarin's sole marketed product, Vascepa came into the market in the U.S. in Jan 2013. Amarin reported $16.2 million in sales of Vascepa for the nine months ending Sep 2013.

Amarin is seeking approval for a label expansion of 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.

The FDA's decision of granting three years of exclusivity was a let down as Amarin expected five years of market exclusivity. Currently, the company is reviewing the FDA's decision and evaluating whether to challenge it.

Amarin currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Endocyte Inc . ( ECYT ), Actelion Ltd. ( ALIOF ) and Biogen Idec Inc. ( BIIB ). Endocyte and Biogen carry a Zacks Rank #1 (Strong Buy) while Actelion holds a Zacks Rank #2 (Buy).


AMARIN CORP PLC (AMRN): Free Stock Analysis Report

BIOGEN IDEC INC (BIIB): Free Stock Analysis Report

ENDOCYTE INC (ECYT): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
Referenced Symbols: CHD , ALIOF , AMRN , BIIB , ECYT

More from Zacks.com




Equity Research

Research Brokers before you trade

Want to trade FX?

Find a Credit Card

Select a credit card product by:
Select an offer:
Data Provided by BankRate.com