DUBLIN, Ireland and BRIDGEWATER, N.J., July 26, 2023 (GLOBE NEWSWIRE) -- Amarin
Corporation plc (NASDAQ:AMRN) today announced the acceptance of funded research
for presentation at the European Society of Cardiology (ESC) Congress, both
onsite and online in Amsterdam, August 25-28, 2023. This new research includes,
along with other topics, the review of the contribution of eicosapentaenoic acid
(EPA) and other biomarkers to MACE reduction by icosapent ethyl (IPE).
The accepted abstracts will be presented by international academic collaborators, including Dr. Deepak L. Bhatt MD, MPH, Director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine, based on
research or analyses sponsored by Amarin.
Featured Amarin-supported abstracts to be presented at ESC Congress 2023
include:
Abstract Sessions Oral Presentation

  * Session: Remnant cholesterol and triglyceride-rich lipoproteins in
    atherosclerosis progression and cardiovascular disease

Eicosapentaenoic Acid, Arachidonic Acid, and Triglyceride Levels Mediate Most of
the Benefit of Icosapent Ethyl in REDUCE-IT
Michael Szarek PhD, Deepak L. Bhatt, MD, MPH, Michael Miller, MD, et al.
-Available: August 26 at 9:24 CET (3:24 a.m. EST) in Lisbon Room
* Session: What's new in lipid lowering?
Effects of Icosapent Ethyl On Residual Cardiovascular Risk According To Predicted Baseline Risk: Results From REDUCE-IT
Pascal M. Burger, Deepak L. Bhatt, Jannick A.N. Dorresteijn, Ph. Gabriel Steg, et al.
-Available: August 27 at 11:05 CET (5:05 a.m. EST) in Science Box 2
Moderated Poster Presentation
* Session: Hypertriglyceridemia treatment: CEPT, icosapent ethyl, and fibrates Cross-Sectional Analysis of Demographic and Clinical Characteristics of Patients
Using Icosapent Ethyl
John R. Nelson, MD, Peter P. Toth, MD, PhD, Handrean Soren, MSc, MD, et al.
-Available: August 27 at 16:15 CET (10:14 a.m. EST) in Station 9
"We continue to be encouraged by new data generated and presented at ESC 2023
which continues to validate and underscore the clinical and therapeutic value of
IPE and VASCEPA/VAZKEPA for clinicians and tens of millions of patients globally," said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer and Head of Global Medical Affairs, Amarin. "These data provide additional evidence for clinicians to make the best therapeutic choice possible for their patients and should bolster confidence in VASCEPA/VAZKEPA as a proven treatment option on top
of statins to reduce CV risk and to help optimize treatment in appropriate high-
risk patients. We are proud of the continued work that is being done to enhance the proven efficacy of VASCEPA/VAZKEPA in cardiovascular risk reduction while providing support to investigators to explore other ways in which VASCEPA can potentially help patients and impact public health."
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in
cardiovascular disease management. We are committed to increasing the scientific
understanding of the cardiovascular risk that persists beyond traditional
therapies and advancing the treatment of that risk for patients worldwide.
Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in
Ireland, Zug in Switzerland, and other countries in Europe as well as commercial
partners and suppliers around the world.
About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the world. In the
United States alone, cardiovascular disease results in 859,000 deaths per
year.(i) and the number of deaths in the United States attributed to
cardiovascular disease continues to rise. In addition, in the United States
there are 605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds). Stroke rates are 795,000 per year
(approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In
aggregate, in the United States alone, there are more than 2.4 million major
adverse cardiovascular events per year from cardiovascular disease or, on
average, 1 every 13 seconds.
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient's risk for cardiovascular events, such as heart attack, stroke or death.
However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.(ii)Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.(iii),(iv),(v)
About REDUCE-IT(®)
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the
effect of VASCEPA in adult patients with LDL-C controlled to between 41-100
mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular
risk factors including persistent elevated triglycerides between 135-499 mg/dL
(median baseline 216 mg/dL) and either established cardiovascular disease
(secondary prevention cohort) or diabetes mellitus and at least one other
cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179
patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.(vi )The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.(vii) The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.(viii) These and other publications can be found in the R&D section on the company's website at www.amarincorp.com (http://www.amarincorp.com).
About VASCEPA(®)/VAZKEPA(®) (icosapent ethyl) Capsules
VASCEPA capsules are the first prescription treatment approved by the U.S. Food
and Drug Administration (FDA) comprised solely of the active ingredient,
icosapent ethyl, a unique form of eicosapentaenoic acid. VASCEPA was launched in
the United States in January 2020 as the first and only drug approved by the
U.S. FDA for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. VASCEPA was initially launched in the
United States in 2013 based on the drug's initial FDA approved indication for
use as an adjunct therapy to diet to reduce triglyceride levels in adult
patients with severe (>=500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA
has been prescribed more than 20 million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, icosapent ethyl is
approved and sold in Canada, Lebanon, and the United Arab Emirates. In Europe,
in March 2021 marketing authorization was granted to icosapent ethyl in the
European Union for the reduction of risk of cardiovascular events in patients at
high cardiovascular risk, under the brand name VAZKEPA. VAZKEPA is being
commercialized in multiple European countries, including England, Wales, Sweden
and Finland.
United States
Indications and Limitation of Use
VASCEPA is indicated:

  * As an adjunct to maximally tolerated statin therapy to reduce the risk of
    myocardial infarction, stroke, coronary revascularization and unstable
    angina requiring hospitalization in adult patients with elevated
    triglyceride (TG) levels (>= 150 mg/dL) and
      * established cardiovascular disease or
      * diabetes mellitus and two or more additional risk factors for
        cardiovascular disease.
  * As an adjunct to diet to reduce TG levels in adult patients with severe (>=
    500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information

  * VASCEPA is contraindicated in patients with known hypersensitivity (e.g.,
    anaphylactic reaction) to VASCEPA or any of its components.
  * VASCEPA was associated with an increased risk (3% vs 2%) of atrial
    fibrillation or atrial flutter requiring hospitalization in a double-blind,
    placebo-controlled trial. The incidence of atrial fibrillation was greater
    in patients with a previous history of atrial fibrillation or atrial
    flutter.

* It is not known whether patients with allergies to fish and/or shellfish are

    at an increased risk of an allergic reaction to VASCEPA. Patients with such
    allergies should discontinue VASCEPA if any reactions occur.
  * VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a
    double-blind, placebo-controlled trial. The incidence of bleeding was
    greater in patients receiving concomitant antithrombotic medications, such
    as aspirin, clopidogrel or warfarin.

* Common adverse reactions in the cardiovascular outcomes trial (incidence >=3%

    and >=1% more frequent than placebo): musculoskeletal pain (4% vs 3%),
    peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and
    atrial fibrillation (5% vs 4%).
  * Common adverse reactions in the hypertriglyceridemia trials (incidence >1%
    more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain
    (1% vs 0.3%).

* Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-

    FDA-1088.
  * Patients receiving VASCEPA and concomitant anticoagulants and/or anti-
    platelet agents should be monitored for bleeding.

FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION
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Europe
For further information about the Summary of Product Characteristics (SmPC) for
VAZKEPA(®) in Europe, please click here
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Globally, prescribing information varies; refer to the individual country
product label for complete information.
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant
to the safe harbor provisions of the Private Securities Litigation Reform Act of
1995, including beliefs about how the data generated and presented at ESC 2023
helps validate and underscore the clinical and therapeutic value of icosapent
etyhl (IPE) and VASCEPA/VAZKEPA for clinicians and millions of patients
globally; and the overall potential and future success of VASCEPA/VAZKEPA and
Amarin generally. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. 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 Amarin's annual report on Form 10-K for the
full year ended 2021. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which speak only as of
the date they are made. Amarin undertakes no obligation to update or revise the
information contained in its forward-looking statements, whether as a result of
new information, future events or circumstances or otherwise. Amarin's forward-
looking statements do not reflect the potential impact of significant
transactions the company may enter into, such as mergers, acquisitions,
dispositions, joint ventures or any material agreements that Amarin may enter
into, amend or terminate.
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the company website
(www.amarincorp.com) and the investor relations website (amarincorp.gcs-
web.com), including but not limited to investor presentations and 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.
Amarin Contact Information
Investor Inquiries:
Jordan Zwick
Amarin Corporation plc
IR@amarincorp.com (mailto:IR@amarincorp.com)
Media Inquiries:
Mark Marmur
Corporate Communications, Amarin Corporation plc
PR@amarincorp.com (mailto:PR@amarincorp.com)
AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals
Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries
and regions and is pending registration in the United States.
--------------------------------------------------------------------------------
(i) (American Heart Association. Heart Disease and Stroke Statistics-2020
Update: A Report From the American Heart Association. )(Circulation)(.
2020;141:e139-e596.)
(ii) (Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive
dyslipidemia therapy in hypertriglyceridemia management. )(J Am Coll
)(Cardiol)(. 2018;72(3):330-343.)
(iii) (Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. )(Am J Cardiol)(. )(2016;118:138-145.)
(iv) (Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated
with increased cardiovascular events, medical costs, and resource use: A real-
world administrative claims analysis of statin-treated patients with high
residual cardiovascular risk. )(J Am Heart Assoc)(. 2018;7(15)():e008740.)
(v) (Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - )(New insights from epidemiology, genetics, and
biology. )(Circ Res)(. 2016;118:547-563.)
(vi) (Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT
Investigators. Rationale and Design of REDUCE-IT: Reduction of Cardiovascular
Events with )(Icosapent Ethyl-Intervention Trial. )(Clin Cardiol)(.
)(2017;40:138-148.)
(vii) (Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT
Investigators. Cardiovascular Risk Reduction with )(Icosapent Ethyl for
Hypertriglyceridemia. )(N Engl J Med)(. )(2019;380:11-22.)
(viii) (Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT
Investigators. Effects of )(Icosapent Ethyl on Total Ischemic Events: From
REDUCE-IT. )(J Am Coll Cardiol)(. )(2019;73:2791-2802.)
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