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AMRN > SEC Filings for AMRN > Form 8-K on 25-Jan-2013All Recent SEC Filings

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Form 8-K for AMARIN CORP PLC\UK


25-Jan-2013

Other Events


Item 8.01. Other Events.

On January 23, 2013, Amarin Corporation plc ("Amarin") announced that United States Patent and Trademark Office ("USPTO") 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 is the first to be allowed with method of use claims intended to protect the proposed Vascepa® (icosapent ethyl) indication based on Amarin's Phase 3 ANCHOR clinical trial results. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. If issued, the patent would have a term that expires no earlier than in 2030.

On January 24, 2013, Amarin announced that Vascepa® (icosapent ethyl) capsules, a therapy approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglyceride levels in adult patients with severe (³500 mg/dL) hypertriglyceridemia, more commonly known as very high triglycerides, is now available in the U.S. by way of physician prescription, and will be supported with a national commercial launch on January 28, 2013.

This Current Report on Form 8-K contains forward-looking statements, including statements concerning: whether the described patent application will be issued; whether the patent application will adequately protect Vascepa against competition; the expiration date of the patent application, if issued; and the timing of a commercial launch of Vascepa. 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 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; the risk of commercializing Vascepa without violating the intellectual property rights of others; uncertainties associated generally with the commercial success of new pharmaceutical products, such as Vascepa; and Amarin's lack of experience as a company with commercializing pharmaceutical products. A more complete list and description of risks, uncertainties and other matters related to an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" section in 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 Current Report on Form 8-K, whether as a result of new information, future events or circumstances or otherwise except as required by law.

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