Amarin Announces Notification of Patent Allowance for AMR101
Notice of Allowance for '598 application
BEDMINSTER, N.J. and DUBLIN, Ireland, March 20, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease, announced today that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for U.S. Patent Application Serial Number 12/052,598 titled "Highly Purified Ethyl EPA and Other EPA Derivatives," also known as the EPA with no DHA in a capsule application. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application.
"The issuance of a notice of allowance is a significant additional step forward in the execution of our plan to protect the commercial potential of AMR101," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Amarin's plan consists of continuing to pursue additional patent protection, seeking regulatory exclusivity, maintaining trade secrets and taking advantage of manufacturing barriers to entry, with the goal of protecting the commercial potential of AMR101 to 2030 and beyond. This patent application is one of Amarin's over 16 pending U.S. patent applications across over 11 patent families."
AMR101 (icosapent ethyl) is an ultra pure omega-3 fatty acid, comprising not less than 96% EPA (icosapent ethyl), that Amarin is developing as a treatment for patients with very high triglyceride levels (≥500 mg/dL), and for patients with high triglyceride levels (≥200 and < 500mg/dL) who are also on statin therapy for elevated low-density lipoprotein cholesterol, or LDL-C, levels (which we refer to as mixed dyslipidemia). The efficacy and safety of AMR101 were studied in two Phase 3 clinical trials, the MARINE trial, which studied patients with very high triglyceride levels, and the ANCHOR trial, which studied patients with high triglyceride levels who were also on statin therapy for elevated LDL-C levels. These two Phase 3 clinical trials showed favorable results in triglyceride reduction compared to
placebo in the studied patient populations. Reduction in triglyceride levels was achieved without a statistically significant increase in LDL-C levels, and in the 4 gram AMR101 ANCHOR results, with a statistically significant decrease in LDL-C levels. These trials also showed favorable results, particularly with the 4 gram dose of AMR101, in other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP. In these trials, AMR101 exhibited a safety profile comparable to placebo. In December 2011, Amarin commenced patient dosing in a cardiovascular outcomes study of AMR101, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA — Intervention Trial), that is designed to evaluate the efficacy of AMR101 in reducing major cardiovascular
events in an at-risk patient population on statin therapy.
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 for the completion of its review. 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.
This press release contains forward-looking statements, including statements and implications about whether a patent will be issued based on a Notice of Allowance that would cover the pharmaceutical composition of AMR101, Amarin's plan to protect the commercial potential of AMR101, Amarin's plans to seek FDA approval of AMR101, the conduct of the company's cardiovascular outcomes study, and the potential populations and indications for which the company's product candidates may be approved by the FDA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that
could interfere with the issuance of a patent, or once issued, the continued validity or enforceability of a patent; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing AMR101without violating the intellectual property rights of others; whether Amarin will obtain and maintain Hatch-Waxman exclusivity for AMR101; uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals; the risk that SPAs are not a guarantee that FDA will approve a product candidate upon submission; and the risk that historical clinical trial enrollment and randomization rates may not be predictive of future results. A further list and
description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Amarin's product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials. Nothing in this press release should be construed as marketing the use of such product candidates.
CONTACT: Investor Contact Information:
Stephen D. Schultz
Investor Relations and Corporate Communications
In U.S.: +1 (860) 572-4979 x292
Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
Media Contact Information:
David Schull or Martina Schwarzkopf, Ph.D.
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile)
Source: Amarin Corporation plc
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