Amarin Corporation plc (AMRN), 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 severe hypertriglyceridemia.
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 US.
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 cholesterol) levels.
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 Valeant Pharmaceuticals (VRX), Targacept Inc. (TRGT) and Aeterna Zentaris (AEZS) look more attractive with a Zacks Rank #1 (Strong Buy).
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