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Amarin Announces Notification Of Patent Allowance For U.S. Application 13/614,129 Related To Vascepa(R) And FDA Approved MARINE Indication

Stocks in this article: AMRN

BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 12, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the United States Patent and Trademark Office (USPTO) has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/614,129. This application includes claims intended to protect the Vascepa ® (icosapent ethyl) indication approved by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results.

A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. After issuance, Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

The claims in this allowed application cover a method of use relating to Vascepa's MARINE indication.  Specifically, the allowed independent claim covers use of a pharmaceutical composition comprising 2000 mg to about 5000 mg of icosapent ethyl, or EPA, independent of DHA content, present in one or more capsules, to reduce triglycerides by at least 20%. 

"The claims in this allowed application cover the described method of administration of a pharmaceutical composition comprising EPA over a broader range of daily EPA doses and amounts of EPA per capsule including, for example, a daily dosing regimen of four capsules, each containing 50% EPA and 50% of one or more other components," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The issuance of this Notice of Allowance represents the broadest MARINE patent to date."

This application is part of an expanding patent portfolio for Amarin with 18 patent applications now either issued or allowed with the USPTO and over 30 additional applications pending in the United States.  Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States.

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