Amarin Announces Notification of Additional U.S. Patent Allowance for U.S. Application 13/272,520 Based on ANCHOR Clinical Trial Results
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."
This application is part of an expanding patent portfolio for Amarin with 16 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, including the application for Amarin's MARINE method of use patent in Europe for which Amarin has announced receipt of an Intention to Grant letter.
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid product comprising not less than 96% EPA. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
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This press release contains forward-looking statements, including statements about whether the subject patent would be issued and adequately protect Vascepa against competition, the expiration date of the pending patent, Amarin's plan to list the patent, when issued, in FDA's Orange Book, Amarin's plan to protect the commercial potential of Vascepa, the future status of pending patent applications, planned regulatory submissions and expected action dates. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that could interfere with the issuance of a patent, or once issued, the continued validity or enforceability of a patent; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing Vascepa without violating the intellectual property rights of others; and uncertainties associated generally with research and development, clinical trials clinical trial enrollment in Amarin's REDUCE-IT trial and related regulatory submissions, action dates and approvals. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Amarin's product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials. Nothing in this press release should be construed as promoting the use of such product candidates.