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February 1, 2013
08:06 EDTAMRNAmarin announces notification of additional U.S. patent allowance
Amarin Corporation announced that the United States Patent and Trademark Office, or 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 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 FDA by the end of February, 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.
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July 31, 2015
07:17 EDTAMRNAmarin announces two presentations on EPA dyslipidemia studies
Amarin announced the presentation of findings from two studies, a retrospective study in which patients were switched from an EPA plus DHA combination product to EPA-only Vascepa as well as a sub-analysis of the ANCHOR clinical trial, at two key cardiovascular meetings. The EPA+DHA to EPA-only switch study investigated the effect of EPA-only omega-3 therapy compared to EPA+DHA therapy on multiple patient lipid parameters. Results of this case series showed a reduction in both triglyceride and low-density lipoprotein cholesterol levels with EPA-only therapy in most of these high-risk statin-treated patients. The ANCHOR sub-analysis is an encore presentation which examined the effect of EPA on high-risk statin-treated patients with persistently high triglyceride levels, showing that icosapent ethyl increased EPA in plasma and red blood cells in a linear, dose-dependent fashion consistent with its triglyceride-lowering effect.
July 24, 2015
16:38 EDTAMRNAmarin files to sell 38.9M series A preference shares in form of ADS for holders
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16:34 EDTAMRNAmarin files to sell 3.89M ordinary shares in form of ADS for holders
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