Amarin Corporation plc
) 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
Biogen Idec Inc.
). Endocyte and Biogen carry a Zacks Rank #1 (Strong Buy) while
Actelion holds a Zacks Rank #2 (Buy).
ACTELION LTD (ALIOF): Get Free Report
AMARIN CORP PLC (AMRN): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
ENDOCYTE INC (ECYT): Free Stock Analysis
To read this article on Zacks.com click here.