Amarin Announces Market Introduction of Vascepa(R) (icosapent ethyl) Capsules
for the Treatment of Very High Triglycerides (VHTG)
-First and Only FDA Approved Pure-EPA Omega-3 Prescription Therapy Now
-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
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
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
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%
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM
Vascepa bottle photo available here
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.^1According 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.
The Amarin Corporation plc logo is available at
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'slack 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 inAmarincan be
found in the "Risk Factors" section ofAmarin'sfilings with theU.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.Amarinundertakes 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
Amarin'sproduct 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 theapproved 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.
CONTACT: Stephen D. Schultz
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
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