Amarin Announces Dosing of First Patient in Cardiovascular Outcomes Study REDUCE-IT
BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 7, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the dosing of the first patient in REDUCE-IT, the cardiovascular outcomes study utilizing AMR101.
REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial), a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study, will evaluate the effectiveness of AMR101 in reducing the prevalence of first major cardiovascular events in a high-risk patient population. All patients in the study will be receiving optimized statin therapy. The active arm of the study will involve patients on optimized statin therapy plus AMR101. All patients enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. Planned enrollment for the trial is approximately 8,000 patients.
"Dosing of the first patient in this study is another significant milestone for Amarin," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The results of REDUCE-IT may enable us to seek additional indications for AMR101 including cardiovascular prevention, which would target a patient population estimated to be almost twice that of the combined indications studied in the MARINE and ANCHOR trials or approximately 70 million adults in the U.S. alone."
Deepak L. Bhatt, M.D., M.P.H., Chief of Cardiology at the VA Boston Healthcare System, Director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital and VA Boston Healthcare System, and principal investigator of REDUCE-IT, said "AMR101 has an excellent safety profile and exceeded the expectations for the treatment of high and very high triglyceride levels in the Phase 3 MARINE and ANCHOR trials. Even beyond LDL-C control with statins, there remains a high unmet medical need for the reduction of cardiovascular risk in the patient population with high triglycerides. Importantly, with REDUCE-IT, we anticipate enrolling a significant number of patients with diabetes similar to the population in the ANCHOR trial."
The REDUCE-IT cardiovascular outcomes study will be conducted under the Company's recently announced Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
In two Phase 3 clinical trials (MARINE and ANCHOR), AMR101, compared to placebo after 12 weeks of treatment, statistically significantly reduced triglyceride levels (the primary endpoint in these trials) at both the 2 gram and 4 gram dose.Other important lipid and inflammation biomarkers, which were secondary and exploratory endpoints in these trials, were also reduced, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP at the 4 gram dose and in some cases at the 2 gram dose. Importantly, neither study demonstrated a statistically significant increase in LDL-C compared to placebo after 12 weeks of treatment. In the ANCHOR study, both the 4 gram and 2 gram doses demonstrated LDL-C non-inferiority, with the 4 gram dose demonstrating a statistically significant 6.2% reduction in LDL-C compared to placebo after 12 weeks of treatment. A significant body of scientific
and clinical data suggests that reductions of these biomarkers may improve cardiovascular health. Such data includes the JELIS study, an outcomes study of over 18,000 patients in Japan in which the addition of 1.8 grams of EPA per day added to statin therapy significantly reduced cardiovascular events in patients being treated for hypercholesterolemia with compared to patients treated with statin therapy alone.
About Dr. Bhatt
Deepak L. Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC, FACP, FCCP, is Chief of Cardiology at VA Boston Healthcare System and Director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital and VA Boston Healthcare System. He is also a Senior Investigator in the TIMI Study Group and an Associate Professor of Medicine at Harvard Medical School.
After graduating as valedictorian from the Boston Latin School, Dr. Bhatt obtained his undergraduate science degree as a National Merit Scholar at the Massachusetts Institute of Technology, while also serving as a research associate at Harvard Medical School. He received his medical doctorate from Cornell University. He completed a Masters in Public Health with a concentration in clinical effectiveness at Harvard University. His internship and residency in internal medicine were performed at the Hospital of the University of Pennsylvania, and his cardiovascular training was completed at Cleveland Clinic. He also completed fellowships in interventional cardiology and cerebral and peripheral vascular intervention, as well as serving as Chief Interventional Fellow, at Cleveland Clinic where he went on
to spend several years as an interventional cardiologist and an Associate Professor of Medicine. He served for many years as Director of the Interventional Cardiology Fellowship and as Associate Director of the Cardiovascular Medicine Fellowship. He also served as Associate Director of the Cleveland Clinic Cardiovascular Coordinating Center. Dr. Bhatt was listed in Best Doctors in America from 2005 to 2011. Dr. Bhatt's research interests include preventive cardiology, as well as the optimal management of patients with acute coronary syndromes. He also has research interests in advanced techniques in cardiac, cerebral, and peripheral intervention. He has authored or co-authored over 500 publications. He is on several editorial boards. He is the editor of Essential Concepts in Cardiovascular Intervention and Guide to Peripheral and Cerebrovascular Intervention, as well as
co-editor of the Handbook of Acute Coronary Syndromes. He was the international principal investigator for the CHARISMA and CRESCENDO trials and co-principal investigator of the CHAMPION and COGENT trials. He serves as the co-chair of the REACH registry. He is also on the steering committees of several trials. He is the current Chair of the AHA-GWTG Science Subcommittee. He is the Associate Editor for clinical trials for the ACC's Cardiosource. Dr. Bhatt has been a visiting lecturer at a number of prestigious institutions throughout the world. He has been interviewed extensively by news agencies on topics ranging from premature coronary artery disease to the role of inflammation and genetics in heart attacks.
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 (greater than or equal to 500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (greater than or equal to 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 [greater than or equal to 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 [greater than or equal to 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 August 2011, an SPA agreement with the FDA was reached for the
REDUCE-IT cardiovascular outcomes study. The Company seeks to have this study substantially underway before the end of 2012.
This press release contains forward-looking statements, including statements about the efficacy, safety and therapeutic benefits of the Company's product candidates, clinical trial results, statements about the clinical importance of certain biomarkers and the impact of AMR101 on such biomarkers and statements regarding residual cardiovascular risk. 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.
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Source: Amarin Corporation plc
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