Amarin Corporation plc
), recently announced that the notice of patent allowance for US
application serial number 13/610,217 has been published by the US
Patent and Trademark Office (USPTO). The patent application aims
to protect Vascepa (icosapent ethyl) till 2030.
We note that in Jul 2012, the US Food and Drug Administration
(FDA) approved Vascepa as an adjunct to diet for reducing
triglyceride levels in adults suffering from severe (≥500 mg/dL)
hypertriglyceridemia (very high triglycerides).
The Ireland based biopharmaceutical company is also looking to
get the patent included in the FDA's Approved Drug Products with
Therapeutic Equivalence Evaluations, also called Orange Book.
We note that the FDA approved Vascepa on the basis of
encouraging data from the MARINE trial. The multi-center,
placebo-controlled, randomized, double-blind, 12-week MARINE
trial (n = 229) evaluated the use of Vascepa is patients with
Amrin is making considerable efforts to expand the patent
protection for Vascepa. Currently in the US, 12 Vascepa patent
applications have been issued or received USPTO patent allowance,
while over 30 additional patent applications are being
prosecuted. The company also plans to protect Vascepa outside the
The company is also seeking to get Vascepa approved for other
indications including the treatment of adult patients with high
triglyceride levels (≥200 mg/dL and <500 mg/dL), who are also
on statin therapy for elevated LDL-C (low-density lipoprotein
We currently have a Neutral recommendation on Amrin. The stock
carries a Zacks Rank #4 (Sell). Pharma stocks, which appear to be
favorably placed include
) look more attractive with a Zacks Rank #1 (Strong Buy).
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