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News Breaks
February 7, 2013
07:44 EDTAMRNAmarin receives patent allowance related to Vascepa
Amarin announced that the USPTO has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/614,146. This application includes claims intended to protect the Vascepa indication approved by the FDA based on Amarin's MARINE clinical trial results. 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. After issuance, Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. The claims in this allowed application cover a method of use relating to Vascepa's MARINE indication. Specifically, the allowed independent claim covers use of icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 2500 mg to about 5000 mg of EPA, independent of DHA content, present in one or more capsules, effective to lower triglycerides in the subject by at least 25% without increasing LDL-C by more than 5%.
News For AMRN From The Last 14 Days
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March 4, 2015
08:19 EDTAMRNAmarin presents data on beneit of fatty acid and atorvastatin combination
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March 3, 2015
18:33 EDTAMRNOn The Fly: After Hours Movers
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16:08 EDTAMRNAmarin says REDUCE-IT continues as centerpiece of R&D efforts
Amarin stated: "The REDUCE-IT cardiovascular outcomes study continues to be the centerpiece of Amarin's on-going R&D efforts. This is the first prospective double-blinded cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. Unlike outcomes studies for many drugs that are designed to validate a currently approved drug indication, based on the results of REDUCE-IT, we plan to seek additional indicated uses for Vascepa that include and extend beyond the populations studied in the MARINE and ANCHOR trials. These additional indications would potentially address tens of millions of patients in the United States and worldwide with elevated triglyceride levels representing an opportunity comparable in size to cholesterol management therapy. In the REDUCE-IT study, we seek to demonstrate benefit by augmenting, not replacing, statin therapy...Thus far the pooled, blinded event rate in the REDUCE-IT study is tracking to our expectations for the 60% interim look by the independent DMC to occur during 2016. Based on the efficacy and safety results at the interim look, the DMC could recommend to the independent Steering Committee and to Amarin to continue or stop the study. If the study is stopped based on overwhelming efficacy results, Amarin intends at that time to progress towards seeking approval for an expanded indication for Vascepa based on such results. Amarin is blinded to the results of the REDUCE-IT study and is planning for REDUCE-IT to continue until attainment of 100% of the 1,612 primary events which is estimated to be in 2017 with results anticipated to be published in 2018."
16:06 EDTAMRNAmarin says FDA has not provided timeline for action on ANCHOR sNDA
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16:03 EDTAMRNAmarin reports Q4 EPS (11c), consensus (13c)
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February 26, 2015
09:23 EDTAMRNAmarin, Eddingpharm agree to develop, commercialize Vascepa in China
Amarin Corporation and Eddingpharm announced an exclusive agreement for Eddingpharm to develop and commercialize Vascepa in the territories of the Mainland China, the Hong Kong and Macao Special Administrative Regions and Taiwan for uses that are currently commercialized and under development by Amarin in the United States based on the MARINE, ANCHOR and ongoing REDUCE-IT clinical trials of Vascepa. Under the agreement, Eddingpharm will be responsible for development and commercialization activities in the territory and associated expenses. Amarin will provide development assistance and be responsible for supplying finished, and later bulk, product. Terms of the agreement include up-front and milestone payments to Amarin of up to $169M, including a non-refundable $15M up-front payment and development, regulatory and sales-based milestone payments of up to an additional $154M. Eddingpharm will also pay Amarin tiered double-digit percentage royalties on net sales of Vascepa in the territory escalating to the high teens. Amarin will supply product to Eddingpharm under negotiated supply terms.
09:00 EDTAMRNAmarin trading halted, pending news
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February 20, 2015
16:03 EDTAMRNOptions Update; February 20, 2015
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10:20 EDTAMRNHigh option volume stocks
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09:38 EDTAMRNActive equity options trading on open
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