Amarin Announces the Addition of Industry Veteran Patrick O'Sullivan to Board
BEDMINSTER, N.J. and DUBLIN, Ireland, Dec. 14, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that Patrick "Paddy" O'Sullivan has joined the Board of Directors as an independent director effective December 13, 2011. Mr. O'Sullivan will also serve on the Audit Committee of the Board of Directors.
Mr. O'Sullivan has more than 40 years of pharmaceutical industry experience, including more than 30 years as Chief Executive Officer and member of the Board of Directors of the LEO Pharma companies in Ireland and more than 10 years as a member of the Board of Directors of the parent company of the LEO Pharma Group in Denmark. Since 2007 Mr. O'Sullivan has been a business consultant to the pharmaceutical industry, and he currently serves as a member of the Board of Directors of Merrion Pharmaceuticals Plc and Warner Chilcott Plc. Mr. O'Sullivan is a registered pharmacist who earned Bachelor of Commerce and Masters of Business Administration degrees from University College in
Dublin. He replaces Dr. Manus Rogan, who, as previously disclosed, intended to retire from the Board this year and does so concurrent with the addition to the Board of Mr. O'Sullivan.
"The addition of Paddy O'Sullivan will further enhance the outstanding talent, pharmaceutical experience and corporate governance of our Board," said Joseph Zakrzewski, Amarin's Chairman and CEO. "As we welcome Paddy to our Board, we thank Manus for his significant contributions to Amarin."
Mr. O'Sullivan added, "I look forward to working with Amarin's Board and management team as the company moves through the approval process for AMR101. With the stellar clinical trial results from both the MARINE and ANCHOR trials, AMR101 should be well positioned for growth as the next generation in lipid management."
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl) that Amarin is developing for the treatment of patients with very high triglyceride levels (≥500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (≥200 and < 500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Triglycerides are fats in the blood. Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP. AMR101 demonstrated a safety profile comparable to placebo in two completed Phase
3 clinical trials.
Amarin Corporation plc is a late-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [≥500 mg/dL]), as reported in November 2010, and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [≥200 and < 500mg/dL] with mixed dyslipidemia), as reported in April 2011. Both the MARINE and ANCHOR trials were conducted under Special Protocol
Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. In September 2011, Amarin submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AMR101 for treatment of the patient population studied in the MARINE trial. Amarin plans to separately seek approval for the population studied in the ANCHOR trial after its REDUCE-IT cardiovascular outcomes trial is substantially underway. In December 2011, patient dosing commenced in the Company's REDUCE-IT cardiovascular outcomes study which study
is being conducted under an SPA agreement with the FDA. The Company seeks to have at least half of the patients required for this study enrolled before the end of 2012.
This press release contains forward-looking statements, including statements about regulatory submissions and the timing of any such review, the efficacy and safety of the Company's product candidates, clinical trial results, the timing of enrolling and advancing a planned cardiovascular outcomes study, and competitive positioning for AMR101 and the ability of Company to achieve current operating priorities. Acceptance of the NDA filing does not represent final evaluation of the adequacy of the data submitted in the NDA. 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 are the following: anticipated operating losses and the likely need for additional capital to fund future operations
and the planned cardiovascular outcomes study; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; risks associated with qualifying new contract manufacturers prior to commercial launch; the risk that SPAs are not a guarantee that FDA will approve a product candidate upon submission; the risk that historical clinical trial enrollment and randomization rates may not be predictive of future results; risks associated with our intellectual property including the risk that our patent applications may not issue; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and
other matters 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 and its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company 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. The Company'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
Senior Director, 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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