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Amarin To Present New Analyses Affirming Robustness of Data from REDUCE-IT and Additional Mechanisms of Action of Eicosapentaenoic Acid (EPA) at American Heart Association (AHA) Scientific Sessions 2025

DUBLIN and BRIDGEWATER, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular care, today announced it will be presenting new findings at the American Heart Association's Scientific Sessions 2025 scheduled for November 7-10 in New Orleans, Louisiana. These new data supported by Amarin will further reinforce the robust efficacy of VASCEPA®/VAZKEPA® (icosapent ethyl) in cardiovascular risk reduction (CVRR) as well as highlight the pleiotropic mechanism of action of Eicosapentaenoic Acid (EPA).

Data being featured at the AHA Scientific Sessions include new analyses from the REDUCE-IT study evaluating the clinical benefit of Icosapent Ethyl (IPE) on cardiovascular (CV) outcomes with or without baseline use of aspirin. Alongside this data is a series of mechanistic studies that explore the anti-oxidant effects of EPA on lipoprotein(a) [Lp(a)] as well as anti-inflammatory and endothelial-protective properties.

Featured Amarin-supported abstracts to be presented by academic collaborators (italicized below) at AHA Scientific Sessions 2025 include:

Abstract Board Session

  • Efficacy of Icosapent Ethyl for Cardiovascular Risk Reduction by Aspirin Use in REDUCE-IT
    Rahul Aggarwal, Deepak L. Bhatt, Christie M. Ballantyne, Michael Miller, Eliot A. Brinton, Terry A. Jacobson, Steven B. Ketchum, Ralph T. Doyle, Jr., Jean-Claude Tardif, Gabriel Steg
    - Available November 9, 3:15 pm CST
    - Population Science Zone
  • Eicosapentaenoic Acid (EPA) Limits Lipoprotein(a) Oxidation and its Related Effects on Endothelial Cell Stress Response Protein Expression
    Samuel C.R. Sherratt, Peter Libby, Richard L. Dunbar, Deepak L. Bhatt, R. Preston Mason
    - Available November 10, 1:00 pm CST
    - Basic Science Zone

Moderated Digital Poster Presentations

  • Eicosapentaenoic Acid (EPA) and GLP-1 Receptor Agonist Combination Enhanced Expression of Src Kinase and Related Pathways in Endothelial Cells during Inflammation
    Samuel C.R. Sherratt, Peter Libby, Richard L. Dunbar, Deepak L. Bhatt, R. Preston Mason
    - Available November 9, 10:04 am CST
    - Basic Science Zone‚ Moderated Digital Poster 27
  • Eicosapentaenoic Acid Attenuates Oxidation of Lp(a) and other Atherogenic Lipoproteins by a Potent Scavenging Mechanism
    Samuel C.R. Sherratt, Peter Libby, Richard L. Dunbar, Deepak L. Bhatt, R. Preston Mason
    - Available November 10, 2:13pm CST
    - Basic Science Zone‚ Moderated Digital Poster 25

About Amarin

Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering over 90 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD.

About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules

VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on 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 twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. 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. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria.

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 CAN BE FOUND AT WWW.VASCEPA.COM.

Europe

For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf

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 Amarin’s key achievements in 2024 and the potential impact and outlook for achievements in 2025 and beyond; Amarin’s 2025 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; expectations regarding potential strategic collaboration and licensing agreements with third parties, including our ability to attract additional collaborators, as well as our plans and strategies for entering into potential strategic collaboration and licensing agreements and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. 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 quarterly report on Form 10-Q for the period ending September 30, 2025 and annual report on Form 10-K for the fiscal year ended 2024. 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. Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (www.amarincorp.com/investor-relations) including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts.

Amarin Contact Information

Media Inquiries:
Tegan Berry
Amarin Corporation plc
PR@amarincorp.com

Investor Inquiries:
Bob Burrows
Western Avenue Advisers LLC
Bob.burrows.ext@amarincorp.com
Investor.relations@amarincorp.com


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