Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, is supporting
the presentation of two accepted scientific presentations at the
National Kidney Foundation 2018 Spring Clinical Meetings in Austin,
April 10-14, 2018.
Reduced kidney function in conjunction with
diabetes mellitus or ongoing inflammation, as denoted by elevated
high sensitivity C-reactive protein (hsCRP) levels, in patients
with persistent high triglycerides (TG) despite statin therapy are
associated with increased cardiovascular disease (CVD) risk.1,
2 The data being presented report that, consistent with
overall study results from the ANCHOR trial, in post hoc analyses
in statin-treated patients with reduced kidney function and
diabetes or elevated hsCRP, prescription pure EPA Vascepa® at
4g/day, compared to placebo, showed reductions in persistent high
(200-499 mg/dL) TG and other potentially atherogenic and
inflammatory markers. The clinical relevance of these data has not
been determined. Amarin's REDUCE-IT trial is evaluating the
potential benefit of icosapent ethyl on CV outcomes in
statin-treated patients with high CV risk, including some patients
with reduced kidney function and diabetes or elevated hsCRP.
Further study is warranted in the millions of Americans with
diabetes and kidney disease with ongoing inflammation.
Data to be presented
include:
Poster Presentations
- Icosapent Ethyl Reduces Potentially Atherogenic Lipid and
Inflammatory Markers in High-Risk Statin-Treated Patients With
Persistent High Triglycerides, eGFR <90 mL/min/1.73 m2, and
Diabetes Mellitus -- H.M. Szerlip, K. Vijay, C.M.
Ballantyne, H.E. Bays, C. Granowitz, R.T. Doyle, R.A. Juliano, S.
Philip
- Icosapent Ethyl Reduces Potentially Atherogenic Lipid and
Inflammatory Markers in High-Risk Statin-Treated Patients With
Persistent High Triglycerides, eGFR <90 mL/min/1.73 m2, and
Elevated High-Sensitivity C-Reactive Protein ≥2.0 mg/L
-- K. Vijay, H.M. Szerlip, C.M. Ballantyne, JR Nelson,
C. Granowitz, R.T. Doyle, R.A. Juliano, S. Philip
“Amarin is excited to present some of the latest
insights on the effects of icosapent ethyl, prescription pure EPA
at 4g/day in patients with reduced kidney function and diabetes or
ongoing inflammation,” said Craig B. Granowitz, M.D., Ph.D., senior
vice president and chief medical officer of Amarin.
About Amarin
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 highly-pure, omega-3
fatty acid product available by prescription. For more
information about Vascepa visit www.vascepa.com. For more
information about Amarin visit www.amarincorp.com.
About REDUCE-IT
Amarin's clinical development program for
Vascepa includes a trial known as the REDUCE-IT cardiovascular
outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT
is the first multinational cardiovascular outcomes study evaluating
the effect of prescription pure EPA therapy, or any triglyceride
lowering therapy, as an add-on to statins in patients with high
cardiovascular risk who, despite stable statin therapy, have
elevated triglyceride levels (150-499 mg/dL). A large portion of
the male and female patients enrolled in this outcomes study are
anticipated to also be diagnosed with type 2 diabetes. As reported
previously, Amarin expects to announce top-line results of this
important study before the end of Q3 2018. The REDUCE-IT
trial is being conducted under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of
Vascepa can be found at www.clinicaltrials.gov.
About VASCEPA® (icosapent ethyl)
Capsules
Vascepa® (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient. Vascepa, known in scientific literature as
AMR101, has been designated a new chemical entity by the FDA.
Amarin has been issued multiple patents internationally based on
the unique clinical profile of Vascepa, including the drug’s
ability to lower triglyceride levels in relevant patient
populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is
indicated 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 and cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been
determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- Use with caution in patients with
known hypersensitivity to fish and/or shellfish.
- The most common reported adverse
reaction (incidence > 2% and greater than placebo) was
arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no
reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Nothing in this press release should
be construed as promoting the use of Vascepa in any indication that
has not been approved by the FDA.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.3,
4
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease.5, 6, 7, 8
Leading clinical investigations seeking to
address cardiovascular risk reduction beyond lowering LDL-C focus
on interrupting the atherosclerotic process (e.g., plaque formation
and instability) by beneficially affecting other lipid, lipoprotein
and inflammation biomarkers and cellular functions thought to be
related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements about the potential efficacy and
therapeutic benefits of Vascepa, including statements about the
unknown clinical relevance of the findings presented as well as
statements concerning the REDUCE-IT cardiovascular outcomes study
such as the anticipated inclusion of certain patient populations,
related timing and announcements with respect to final outcomes and
the anticipated successful completion of the REDUCE-IT study. 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 include uncertainties associated
generally with retrospective subset analyses, research on
biomarkers thought to be relevant in the treatment of
cardiovascular disease, research and development and clinical trial
risk generally, including the risk that study results in modest
sample sizes may not be predictive of future results in larger
studies, that studied parameters may not have clinically meaningful
effect and the risk that patents may not adequately protect Vascepa
against competition. A further list and description of these risks,
uncertainties and other risks associated with an investment in
Amarin 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. 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.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the investor relations
website (http://investor.amarincorp.com/), including but not
limited to investor presentations and investor FAQs, Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that Amarin posts on
these channels and websites could be deemed to be material
information. As a result, Amarin encourages investors, the
media, and others interested in Amarin to review the information
that is posted on these channels, including the investor relations
website, on a regular basis. This list of channels may be
updated from time to time on Amarin’s investor relations website
and may include social media channels. The contents of
Amarin’s website or these channels, or any other website that may
be accessed from its website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
References
1 Palsson R, et al. Adv Chronic Kidney Dis. 2014. Gansevoort RT,
et al. Lancet. 2013
2 Stuveling EM, et al. Kidney Int. 2003
3 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update.
4 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.
5 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
6 Toth PP, Granowitz C, Hull M, et al. High triglycerides
increase cardiovascular events, medical costs, and resource
utilization in a real-world analysis of statin-treated patients
with high cardiovascular risk and well-controlled low-density
lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl
1):A15187.
7 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
8 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular
disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:Elisabeth Schwartz Investor Relations and
Corporate Communications Amarin Corporation plc In U.S.: +1
(908) 719-1315 investor.relations@amarincorp.com Lee M. Stern Trout
Group In U.S.: +1 (646)
378-2992lstern@troutgroup.com Media Inquiries: Kristie
Kuhl Finn Partners In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com
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