Amarin (AMRN) Receives Notice of Allowance for Patent App '569

January 23, 2013 11:31 AM EST Send to a Friend
Amarin Corporation plc (Nasdaq: AMRN) announced that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for Amarin's U.S. Patent Application Serial Number 12/815,569 titled "Compositions and Methods for Lowering Triglycerides Without Raising LDL-C Levels in a Subject on Concomitant Statin Therapy." This application includes claims intended to protect the proposed Vascepa® (icosapent ethyl) indication based on Amarin's Phase 3 ANCHOR clinical trial results. Amarin is on track to file a Supplemental New Drug Application for the Vascepa ANCHOR indication with the U.S. Food and Drug Administration (FDA) by the end of February 2013, and expects an FDA action date on the application before the end of 2013.

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. Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent and the anticipated approval of Vascepa in the ANCHOR indication.

The claims in this allowed application cover a method of use relating to Vascepa's ANCHOR indication. Specifically, the allowed independent claim covers use of icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 4 capsules, each containing about 900 mg to about 1000 mg of EPA, regardless of EPA purity with not more than about 3% docosahexaenoic acid.

This application is part of an expanding patent portfolio for Amarin with 13 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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