Amarin Announces Successful MARINE Phase 3 Clinical Trial Results Published in The American Journal of Cardiology
BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 1, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that results of its pivotal MARINE Phase 3 clinical trial were published in the September issue of The American Journal of Cardiology. The Company also reported, as previously announced, that data from the Company's Phase 3 MARINE trial was presented at the European Society of Cardiology (ESC) Congress 2011.
The publication titled, Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Patients with Very High Triglyceride Levels (From the MARINE Trial), provides a peer-reviewed summary of the previously reported Phase 3 MARINE clinical trial data of Amarin's lead product candidate AMR101, in which a statistically significant reduction in triglyceride levels and other lipid parameters was observed without a statistically significant increase in LDL-cholesterol. This is the first peer-reviewed publication of the results from this trial, the largest conducted in the patient population studied (TG >500mg/dL). As previously announced, the primary endpoint of this study was successfully achieved at daily doses of both 2 grams and 4 grams of AMR101. The results also suggest that AMR101was safe and well tolerated.
The Company also summarized additional results of the MARINE trial results as presented this week at the European Society of Cardiology (ESC) Congress, including new data presented on reductions in high-sensitive C-reactive protein (hs-CRP). Elevated hs-CRP is associated with vascular inflammation. Separately, data was presented indicating that AMR101 significantly increased, in a dose-dependent manner, the EPA concentration in plasma and red blood cells.
"I am pleased that the important data from the MARINE study has been accepted for publication in such a respected, peer-reviewed journal as The American Journal of Cardiology," stated Joseph Zakrzewski, Executive Chairman and CEO of Amarin. "The data from the publication and those presented at ESC suggest that pure EPA therapy not only reduces triglyceride levels, but also improves additional non-lipid parameters which research suggests may provide broader clinical benefit."
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine 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). 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-PLA(2), and hs-CRP without increasing LDL-C. AMR101 demonstrated a safety profile comparable to
placebo in two complete Phase 3 clinical trials.
About MARINE Trial
The MARINE study was the largest study ever conducted with omega-3 fatty acids in treating patients with very high triglycerides (>500 mg/dL). AMR101 (icosapent ethyl) was studied in this population, compared to placebo, at doses of 4 grams and 2 grams per day. As reported in November 2010, the primary endpoint of the MARINE study was achieved with statistically significant reductions in triglycerides compared to placebo of 33% (P<0.0001) for the 4 gram and 20% (P=0.0051) for the 2 gram per day doses, respectively. AMR101 did not result in a statistically significant increase in median LDL-C compared to placebo at either dose. Current therapies which address this population increase LDL-C ("bad cholesterol") by 40-50%.
In statin-treated patients, AMR101 4 gram per day reduced placebo-corrected median triglyceride levels by 65% (p = 0.0001) and AMR101 2 gram per day reduced placebo-corrected median triglyceride levels by 40.7% (p = 0.0276). Among patients with baseline triglycerides >750 mg/dL, AMR101 4 gram per day reduced placebo-corrected median triglyceride levels by 45.4% (p = 0.0001); AMR101 2 gram per day reduced placebo-corrected median triglycerides in this subgroup by 32.9% (p = 0.0016).
Amarin Corporation plc is a clinical-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 on November 29, 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 on April 18, 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.
This press release contains forward-looking statements, including statements about the efficacy, safety and market opportunities ofAMR101, including statements about the clinical importance of certain biomarkers and the impact of AMR101 on such biomarkers. 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 accept an NDA or approve a product candidate upon submission; the risk that historical clinical trial enrolment and randomization rates may not be predictive of future results; risks associated with our intellectual property including the risk that our recently filed 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
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.
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Source: Amarin Corporation plc
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