) shares skid around 23.8% on Jan 21 after the Division of
Metabolism and Endocrinology Products (DMEP) within the U.S. Food
and Drug Administration (FDA) turned down Amarin's request for
reconsideration of DMEP's Oct 2013 decision.
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In Oct 2013, the Endocrinologic and Metabolic Drugs Advisory
Committee of the FDA voted against the approval of the company's
only product, Vascepa, for an additional indication. Amarin is
seeking to get Vascepa approved as an adjunct to diet and
exercise and in combination with a statin for treating adults
suffering from 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
At the advisory committee meeting the DEMP stated that the
available data did not support the use of drug-induced reductions
in serum triglycerides as a basis for the approval of Vascepa in
the ANCHOR indication. On Jan 21, 2014, Amarin announced that the
DEMP had turned down its request to reinstate the special
protocol assessment in the ANCHOR study by maintaining its
advisory committee meeting verdict.
We are disappointed with the DMEP rejecting Amarin's request for
reconsideration of the Oct 2013 decision. Amarin is however
leaving no stone unturned to get the drug approved for the ANCHOR
indication. Amarin mentioned in its conference call that the DMEP
did not respond to its 20 questions. The company now plans to
appeal to the FDA Director of the Office of Drug Evaluation II
(ODE-II) against the DMEP decision. However, a decision on
Vascepa's supplemental New Drug Application for the ANCHOR
indication (accepted by the FDA in Apr 2013) will not be
available till the appeal is pending.
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. 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.
The company intends to focus on expanding Vascepa's sales
potential. Moreover, Amarin intends to explore ex-U.S.
opportunities for Vascepa. We expect investor focus to remain on
updates on the drug's ANCHOR indication.
Amarin carries a Zacks Rank #4 (Sell). Some better-ranked stocks
). All these stocks hold a Zacks Rank #1 (Strong Buy).