) announced that its cardiovascular outcomes study, REDUCE-IT
(Reduction of Cardiovascular Events with EPA - Intervention
Trial), has enrolled more than 6,000 patients. The study, which
commenced in Dec 2011, is evaluating Vascepa's safety and
efficacy as an adjunct therapy in reducing first major
cardiovascular events in a high risk patient population on statin
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REDUCE-IT, a multinational, prospective, randomized,
double-blind, placebo-controlled, parallel-group study, is being
carried at 400 sites across 11 countries. While the control
arm includes patients on statin therapy plus placebo, the active
arm comprises patients on statin therapy plus Vascepa (4g/day).
In Jul 2013, Amarin had raised approximately $121.1 million
through the issuance of 21.7 million American Depository Shares.
The company intends to use the funds for the ongoing launch of
Vascepa and also for advancing the REDUCE-IT study.
We note that Vascepa, the only marketed product of the company,
is approved in the U.S. as an adjunct to diet for reducing
triglyceride levels in adults suffering from severe
hypertriglyceridemia. Amarin started marketing the drug in the
U.S. in Jan 2013. The company sometimes refers to this as the
MARINE indication. Amarin reported $5.5 million sales of Vascepa
in the second quarter of 2013.
The company is also seeking to get Vascepa approved for the
treatment of adults with high triglyceride levels (≥200 mg/dL and
<500 mg/dL), who are receiving statin therapy for elevated
LDL-C (low-density lipoprotein cholesterol) levels. Amarin refers
to this as the ANCHOR indication. In Apr 2013, the U.S. Food and
Drug Administration accepted the supplemental New Drug
Application (sNDA) for the ANCHOR indication. A response from the
FDA should be out by Dec 20, 2013.
Amarin carries a Zacks Rank #3 (Hold). Companies that currently
look well-positioned include
) with a Zacks Rank #1 (Strong Buy), and
Jazz Pharmaceuticals Public Limited Company
) with a Zacks Rank #2 (Buy).