BEDMINSTER, N.J. and DUBLIN, Ireland, Nov. 7, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late stage biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for Q3, the quarter ended September 30, 2013, and provided an update on company operations.

Key Amarin accomplishments and setbacks since June 30, 2013 include:

  • Recognized $8.4 million in product revenue from Vascepa® sales in Q3, the second full quarter of Vascepa sales, as compared to $5.5 million in Q2
  • Normalized prescriptions, based upon data from Symphony Health, increased by 58% in Q3 to 74,576 from 47,335 in Q2
  • Improved formulary access by increasing number of lives covered with Tier 2 status to 92 million with over 200 million lives covered on formulary overall
  • Increased the number of physicians prescribing Vascepa to over 13,000
  • Surpassed 6,000 patients enrolled in the REDUCE-IT cardiovascular outcomes trial in which the mean and median baseline triglyceride, or TG, levels in patients participating in the study to date are > 200 mg/dL, a level which is intentionally higher than studied in recently conducted outcomes trials of other prescription lipid modifying therapies
  • Increased patents issued or allowed in the United States to 37, adding 10 in Q3, which include multiple claims directed at the administration of pure EPA to lower triglycerides with or without statin therapy (26 year-to-date), all but two of the 37 have patent terms extending into 2030, with more than 30 additional patent applications being prosecuted in the United States alone
  • Completed an equity financing resulting in approximately $121.2 million in net proceeds helping to provide an improved financial foundation for the company
  • Reduced worldwide staffing by half in October to reduce costs and better match the operational size of Amarin for commercialization of the current indication for Vascepa following a negative recommendation (2 to 9 vote) from an FDA advisory committee on the pending ANCHOR sNDA

"We continue to witness the growth of awareness, Tier 2 managed care conversions, and prescription volume for Vascepa, seeing an increase of 58% in normalized TRxs from Q2 to Q3 of this year," said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "We believe our dedicated and talented employees will be able to continue to grow our commercial business. We also believe that the efficacy and safety profile of Vascepa for its approved indication reflects a unique and favorably differentiated product which is well positioned to help clinicians provide improved care to their patients."

Commenting on the FDA's recently expressed position that the results from the ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE trials fail to support the hypothesis that a TG-lowering drug significantly reduces the risk for cardiovascular (CV) events among statin-treated patients and that such results constitute a new substantial scientific issue, Steven B. Ketchum, Ph.D., President of Research and Development of Amarin provided, "We intend to continue to work vigorously in support of improved patient care and labeling of Vascepa for the ANCHOR indication. Toward that end, we have submitted to the FDA all materials needed to appeal the FDA rescission of the ANCHOR Special Protocol Assessment, or SPA, agreement and have begun the formal appeal process with FDA. We believe that had the FDA advisory committee been asked to vote on the indication supported by the SPA agreement for ANCHOR and by the ANCHOR results submitted in our sNDA, the outcome would have favored Vascepa approval." Amarin plans on today's conference call to further discuss this appeal and Amarin's perspective on why the ANCHOR indication should be approved.

Operational update

Commercialization update

Vascepa is being marketed as an adjunct to diet to reduce triglyceride levels in adult patients with severe (

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