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December 6, 2012
16:09 EDTAMRNAmarin announces $100M non-equity financing
Amarin announced a $100M non-equity financing with an investment fund managed by Pharmakon Advisors and that Amarin is continuing its preparations to commercialize Vascepa (icosapent ethyl) capsules with the hiring of a sales force in the United States. Payments by Amarin under this hybrid debt-like instrument are expected to be made over a 3.5-year period commencing in November 2013 and to continue through early 2017. As previously announced, the initial commercial launch of Vascepa is planned for early in the first quarter of 2013. The company is hiring 250-300 specialty sales professionals for the launch of Vascepa for its initial indication, the MARINE indication, which is approved by the U.S. Food and Drug Administration. Amarin's goal is for every sales representative hired to have, at a minimum, three to five year existing relationships with the identical physician groups Amarin will be calling on and educating about Vascepa. In addition to hiring a sales force, Amarin has been focused on continued commercial preparations for Vascepa which, as previously disclosed, has included, but has not been limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building up inventory levels, hiring key personnel (e.g., managed care, marketing, sales infrastructure, pricing), developing direct-to-consumer advertising and speaker training and coordinating other pre-launch marketing activities. Amarin's hiring of a sales force is part of a continuing strategy to evaluate three potential paths to Vascepa commercialization: an acquisition of Amarin, a strategic collaboration, and self-commercialization, the latter of which could include third-party support.
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April 28, 2015
06:51 EDTAMRNAmarin discloses receipt of anticipated CRL from FDA regarding Vascepa
In a regulatory filing, Amarin announced receipt of the anticipated Complete Response Letter from the FDA regarding its Vascepa capsules ANCHOR trial supplemental New Drug Application. Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia. Current Vascepa labeling remains unchanged. The ANCHOR sNDA sought to expand approved Vascepa labeling to include use as an adjunct to diet to reduce TG levels in adult patients on statin therapy with mixed dyslipidemia and triglyceride levels from 200 to 499 mg/dL, the ANCHOR population. In the CRL, FDA acknowledged that Vascepa yielded a treatment difference showing reduced TG levels compared to placebo in patients treated in the ANCHOR study. The clinical rationale for reducing serum TGs with Vascepa and modifying other lipid/lipoprotein parameters shown in ANCHOR among statin-treated patients with TGs 200-499 mg/dL is to reduce cardiovascular risk. FDA concluded that, for regulatory approval purposes, there are insufficient data at this time to support a drug-induced change in serum TGs as a surrogate for reducing cardiovascular risk in the ANCHOR population. FDA did not determine that the drug-induced effects of Vascepa, which go beyond TG-lowering, would not actually reduce cardiovascular risk in this population. Amarin had proposed to FDA multiple alternative indications, data presentations, disclaimers and other regulatory pathways to approval under the sNDA, but FDA determined not to approve label expansion reflecting the ANCHOR clinical trial efficacy data at this time. Safety data from the ANCHOR study remains in the currently approved label for Vascepa.

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