The U.S. Food and Drug Administration's (FDA) Endocrinologic
and Metabolic Drugs Advisory Committee dealt a blow to
) with the panel voting 9 to 2 against granting approval to the
company's Vascepa capsule for an additional indication.
Amarin is looking 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
We note that in Apr 2013, the FDA accepted the supplemental
New Drug Application (sNDA) for the ANCHOR indication. A response
from the FDA should be out by Dec 20, 2013.
We note that Vascepa, the only marketed product of the
company, is currently 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. Amarin reported $5.5 million sales of
Vascepa in the second 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.
In Sep 2013, Amarin 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 to statin therapy in reducing
first major cardiovascular events in a high risk patient
In Jul 2013, Amarin had raised approximately $121.1 million
(net) through the issuance of 21.7 million American Depository
Shares. The company is using the funds for the ongoing launch of
Vascepa and also for advancing the REDUCE-IT study.
Amarin carries a Zacks Rank #3 (Hold). Companies that
currently look well-positioned include
Endo Health Solutions Inc.
) with a Zacks Rank #1 (Strong Buy), and
Alexion Pharmaceuticals, Inc.
) with a Zacks Rank #2 (Buy).
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