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News Breaks
January 21, 2014
05:13 EDTAMRNAmarin announces FDA DMEP 'does not plan to reinstate ANCHOR SPA agreement'
Amarin announced that the Division of Metabolism and Endocrinology Products, or DMEP, within the FDA has notified Amarin in connection with Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment, or SPA, agreement that DMEP "does not plan to re-instate the ANCHOR SPA agreement." In its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease. Prior to being able to appeal DMEP's October 2013 decision to rescind the ANCHOR SPA agreement, FDA protocol requires that DMEP first be given a formal opportunity for reconsideration. With that step now completed, Amarin plans to appeal the DMEP decision to the FDA Director of the Office of Drug Evaluation II, or ODE-II, the next level under FDA dispute resolution guidance. Based on information available to Amarin, Amarin does not expect a determination on the pending ANCHOR sNDA while Amarin prepares its appeal or while this appeal is pending. Amarin also plans to continue its efforts toward a positive determination on the pending ANCHOR sNDA.
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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February 18, 2015
10:05 EDTAMRNOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Agnico Eagle (AEM) upgraded to Overweight from Neutral at JPMorgan... Amarin (AMRN) upgraded to Buy from Neutral at SunTrust... Capital Product (CPLP) upgraded to Accumulate from Neutral at Global Hunter... Carlyle Group (CG) upgraded to Buy from Neutral at Citigroup... Danone (DANOY) upgraded to Neutral from Underperform at Exane BNP Paribas... Express (EXPR) upgraded on lower promotional activity at Piper Jaffray... Kforce (KFRC) upgraded to Outperform from Market Perform at Avondale... Legg Mason (LM) upgraded to Buy from Hold at Jefferies... Rackspace (RAX) upgraded following Q4 results at Pacific Crest... Rosetta Resources (ROSE) upgraded to Buy from Neutral at Global Hunter... SeaChange (SEAC) upgraded to Buy from Hold at Noble Financial... Valero (VLO) upgraded to Outperform from Neutral at Credit Suisse... Veeco (VECO) upgraded to Buy from Hold at Noble Financial... Wolverine World Wide (WWW) upgraded to Neutral from Underperform at Sterne Agee.
09:10 EDTAMRNOn The Fly: Pre-market Movers
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06:05 EDTAMRNAmarin upgraded to Buy from Neutral at SunTrust
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