-First and Only FDA Approved Pure-EPA Omega-3 Prescription Therapy Now Available-
-Vascepa Reduces VHTG Without Raising LDL Cholesterol-
BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 24, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced that Vascepa® (icosapent ethyl) capsules, a therapy for patients in the United States to treat severe (≥500 mg/dL) hypertriglyceridemia more commonly known as very high triglycerides, or VHTG, is now available by way of physician prescription, and will be supported with a national commercial launch on January 28, 2013.
Vascepa is a new prescription pure-EPA omega-3 therapy approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Triglycerides, like cholesterol, are a type of fat in the bloodstream. It is estimated that approximately four million adults in the United States have VHTG levels.
Vascepa is the first FDA-approved VHTG therapy to have demonstrated, in published controlled clinical trials, significant reduction in levels of triglycerides without elevation in levels of LDL-C and with a tolerability and safety profile similar to placebo. LDL-C is commonly referred to as "bad cholesterol" and is a primary cardiovascular risk factor. Vascepa also significantly improved many other important lipid parameters including apo B, non-HDL-C, TC and VLDL-C.
"Guidelines for the management of very high triglycerides state that reducing TG levels is the primary focus of therapy in patients with VHTG, due to the fact that severe hypertriglyceridemia contributes to the risk of acute pancreatitis," said Eliot A. Brinton, MD, Director, Atherometabolic Research, Utah Foundation for Biomedical Research, and Vice President, American Board of Clinical Lipidology. "Ideally, therapy that lowers very high triglycerides should not elevate LDL-C – a major risk factor for cardiovascular disease, but other VHTG therapies substantially raise LDL-C."
"Amarin has worked closely with leading clinical experts and regulatory authorities to bring this important new prescription pure-EPA omega-3 therapy to patients with very high triglycerides," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Other approved products for treating very high triglycerides have long been associated with raising LDL-C – commonly called bad cholesterol. Vascepa is the first prescription medicine for VHTG that does not raise LDL-C while significantly reducing very high triglycerides and providing a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo. We expect this to be an important consideration in patient care as we educate physicians and other providers about the product."
About Vascepa® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.
Vascepa® (icosapent ethyl) is indicated for use in the United States as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
The effect of Vascepa on the risk for pancreatitis or on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Amarin is currently conducting a cardiovascular outcomes study called REDUCE-IT. This study is designed to evaluate the efficacy of Vascepa in reducing major cardiovascular events in an at-risk patient population on statin therapy.
The only reported adverse reaction with an incidence >2% and greater than placebo in Vascepa treated patients was arthralgia (2.3% for Vascepa vs. 1.0% for placebo).
About Severe (>500 mg/dL) Hypertriglyceridemia, or VHTG
Severe hypertriglyceridemia refers to a condition in which patients have very high (≥500 mg/dL) levels of triglycerides in the bloodstream. Amarin estimates that approximately 4 million people in the United States have VHTG. Official U.S. guidelines for the management of VHTG state that reducing triglyceride levels is the primary lipid treatment goal in patients with VHTG levels to reduce the risk of acute pancreatitis.1 According to The American Heart Association Scientific Statement on Triglycerides and Cardiovascular Disease (2011), triglycerides also provide important information as a marker associated with the risk for heart disease and stroke, especially when an individual also has low high-density lipoprotein cholesterol, or HDL-C (often referred to as "good" cholesterol), and elevated levels of LDL-C (often referred to as "bad" cholesterol).
1 Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): Final Report. National Heart, Lung, and Blood Institute. Bethesda, MD: National Institutes of Health; September 2002. Publication No. 02-5215; Oh RC, Lanier JB. Management of hypertriglyceridemia. Am Fam Physician. 2007;75(9):1365-1371.
Glossary of terms used
apo B (apolipoprotein B), EPA (icosapent ethyl), LDL-C (Low Density Lipoprotein Cholesterol), non-HDL-C (total cholesterol less "good cholesterol"), TC (Total Cholesterol), TG (Triglycerides), VLDL-C (Very Low Density Lipoprotein Cholesterol).
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid product comprising not less than 96% EPA and is available for use by prescription for the treatment of severe (≥500 mg/dL) hypertriglyceridemia. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
This press release contains forward-looking statements, including statements about the efficacy, safety and therapeutic benefits of Vascepa, clinical trial results, the clinical importance of certain biomarkers and the impact of Vascepa on such biomarkers, the timing of a commercial launch of Vascepa, and the commercial potential of Vascepa. 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 herein include the following: uncertainties associated generally with the commercial success of new pharmaceutical products, such as Vascepa; and Amarin's lack of experience as a company with commercializing pharmaceutical products. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in the "Risk Factors" section of Amarin's filings with the U.S. Securities and Exchange Commission, including 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. 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 except as required by law.
Amarin's product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials, except as it relates to the approved indication described herein. This press release is intended for communication with investors. Nothing in this press release should be construed as marketing the use of such product candidates.