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Patent Application Related to High (≥200 mg/dL to <500 mg/dL) Triglyceride Patient Population With Mixed Dyslipidemia
BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 1, 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 a Notice of Allowance for Amarin's U.S. Patent Application Serial Number 13/272,520 titled "Compositions and Methods for Lowering Triglycerides." 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 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 claims covers use of about 4 grams per day of highly pure icosapent ethyl, or EPA, including Vascepa, to lower triglycerides and LDL-C.
"This Notice of Allowance with method of use claims related to our planned ANCHOR indication for Vascepa follows the recent '569 Notice of Allowance, also for the ANCHOR indication, and also covers administration of Vascepa to patients on any statin product," stated Joseph Zakrzewski, Chairman and CEO of Amarin. "This allowance is based upon showings that important clinical results for Vascepa in Amarin's ANCHOR trial were surprising and unexpected, key factors considered by the USPTO in granting a patent."