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Amarin Corporation – In 2012 working to build the value of AMR101

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Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company focused on cardiovascular disease, today announced financial results for the quarter and year ended December 31, 2011 and provided an update on company operations.

Key Amarin accomplishments since the quarter ended September 30, 2011 include:

  • Acceptance of AMR101 New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) and FDA assignment of Prescription Drug User Fee Act (PDUFA) date of July 26, 2012
  • Strengthened balance sheet through successful completion of a $150M exchangeable note offering
  • Commenced patient enrollment and dosing in the REDUCE-IT cardiovascular outcomes study
  • Broadened management team with the addition of a General Counsel and a President of R&D

“In 2011, Amarin made important progress toward the development of, and commercial preparedness for, our lead product candidate, AMR101,” said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. “In 2012 we are working vigorously to build on this progress and maximize the value of AMR101 as we advance toward the PDUFA date.”


Amarin’s 2012 operational priorities

Amarin’s 2012 operational priorities include the following:

  • NDA approval for the MARINE indication, which we expect to occur in the second half of 2012
  • Commercial readiness to launch AMR101 through a strategic partner or by Amarin likely with third-party resources
  • Patent protection potentially extending AMR101′s proprietary position to 2030
  • REDUCE-IT cardiovascular outcomes study substantially underway by year-end
  • sNDA submission for the mixed dyslipidemia indication studied in the ANCHOR trial
  • Publication of data from the ANCHOR trial in a prominent peer-reviewed journal
  • Announcement of a fourth active pharmaceutical ingredient supplier
  • Potential commencement of pharmacokinetic study of a combination product comprised of AMR101 and a leading statin

About Amarin

Amarin Corporation plc is a late-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. Amarin has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate, AMR101, in the treatment of patients with very high triglyceride levels (the population studied in Amarin’s MARINE trial), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012. Amarin plans to separately seek approval for use of AMR101 in the treatment of patients with high triglyceride levels who are also on statin therapy for elevated LDL-C levels, the population studied in the ANCHOR trial, if the FDA approves the MARINE indication and after the REDUCE-IT cardiovascular outcomes trial is substantially underway. Each of the MARINE, ANCHOR and REDUCE-IT studies is the subject of a Special Protocol Assessment (SPA) agreement with the FDA. Amarin also has next-generation lipid candidates under evaluation in preclinical development.

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edliston
Post Written By: Ed Liston

Ed Liston is a senior contributing editor at TheStockMarketWatch.com. An active market watcher and investor, Ed guides an independent team of experienced analysts and writes for multiple stock trader publications. He is widely quoted in various financial publications on the Internet. When Ed is not writing about stocks, investing in stocks, talking about stocks, or otherwise doing something stock related, he likes to go sailing and fishing in his yacht.


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Ed Liston

Ed Liston is a senior contributing editor at TheStockMarketWatch.com. An active market watcher and investor, Ed guides an independent team of experienced analysts and writes for multiple stock trader publications. He is widely quoted in various financial publications on the Internet. When Ed is not writing about stocks, investing in stocks, talking about stocks, or otherwise doing something stock related, he likes to go sailing and fishing.

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