Latest Research Evaluating VASCEPA® (Icosapent Ethyl) to be Presented at the American College of Cardiology’s 71st Annual Scientific Session

Rhea-AI Summary

Amarin Corporation has announced research on VASCEPA and VAZKEPA to be presented at the American College of Cardiology’s 71st Annual Scientific Session from April 2-4, 2022. Six posters will highlight findings related to the effectiveness of icosapent ethyl in reducing cardiovascular risks, particularly when combined with high-intensity statins. CEO Karim Mikhail expressed optimism about the continuous expansion of the evidence base regarding icosapent ethyl's potential role for high-risk patients.

Positive

• Six research posters on VASCEPA presented at the ACC 2022 conference highlight its potential cardiovascular benefits.
• Research indicates icosapent ethyl could reduce cardiovascular risk when combined with high-intensity statins.

Negative

• None.

Amarin-Supported Research and Analyses to Be Featured in Six Presentations

DUBLIN, Ireland and BRIDGEWATER, N.J., March 21, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced a diverse and full slate of supported and/or funded research on VASCEPA^®/VAZKEPA (icosapent ethyl) to be presented in six posters at the American College of Cardiology’s 71st Annual Scientific Session in Washington, DC, April 2-4, 2022.

The posters explore a range of assessments of icosapent ethyl (the highly purified, prescription form of eicosapentaenoic acid, or EPA), including a comparison of its impacts when combined with the most widely used high intensity statins vs. when the statins alone were used.

“We are always pleased to be a part of this important meeting – especially when new data and insights on icosapent ethyl are available to be shared and discussed,” said Karim Mikhail, Amarin’s president and chief executive officer. “As the evidence base on icosapent ethyl continues to expand in interesting ways, we are particularly encouraged by what we’re learning about the potential role it can play in combination with statins for patients that are at highest risk.”

Featured Amarin-supported abstracts to be presented at ACC.22 include:

Saturday, April 2, 2022

Session 1188 - Prevention and Health Promotion: Lipids Digital Presentations eAbstract site; 8:30am Icosapent Ethyl Reduces Cardiovascular Risk Substantially and Consistently Regardless of Waist Circumference - presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Boston, MA, USA Session 1276 -- Vascular Medicine: Pharmacology 2 Poster Hall, Hall C; 10:45 – 11:30 AM Eicosapentaenoic Acid (EPA) Combined with High Intensity Statins Reduce Lipid Oxidation in Model Membranes - presented on behalf of all authors by R. Preston Mason, Ph.D., Elucida Research LLC, Beverly, MA, USA

Sunday, April 3, 2022

Session 1453 Vascular Medicine: Basic and Translational Science 11 Poster Hall, Hall C; 2:45 – 3:30 PM Eicosapentaenoic Acid (EPA) Increases Heme Oxygenase-1 Expression in Macrophages and Endothelial Cells During Inflammation- presented on behalf of all authors by Preston Mason, Ph.D., Elucida Research LLC, Beverly, MA, USA Eicosapentaenoic Acid (EPA) Decreases Angiotensin Converting Enzyme (ACE) Expression in Vascular and Pulmonary Endothelium Following Cytokine Challenge- presented on behalf of all authors by R. Preston Mason, Ph.D., Elucida Research LLC, Beverly, MA, USA Eicosapentaenoic Acid (EPA) Reduces Inflammation and Improves Nitric Oxide Bioavailability in Pulmonary Endothelial Cells Following Exposure to Air Pollution Particles- presented on behalf of all authors by R. Preston Mason, Ph.D., Elucida Research LLC, Beverly, MA, USA

Monday, April 4, 2022

Session 1108 Vascular Medicine Basic/Translational Science: Special Topics Moderated Poster Theater 5_Hall C; 10:00 – 10:10 AM Eicosapentaenoic Acid (EPA) Reduces J774 Macrophage Activation and Cyclooxygenase (Cox-1) Expression - presented on behalf of all authors by R. Preston Mason, Ph.D., Elucida Research LLC, Beverly, MA, USA

About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our foundation in scientific research to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. 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. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk.

About VASCEPA^® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only 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 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 over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA 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.

Indications and Limitation of Use (in the United States)

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.

Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:

FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

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 statements regarding any new potential clinical impact of VASCEPA i, the outcomes or impact of any specific new or ongoing clinical trials or studies, significance of any data generated in new or ongoing clinical trials or studies and general statements about the safety and effectiveness of VASCEPA. 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 communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.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: Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
IR@amarincorp.com (investor inquiries)

Media Inquiries: Communications
Amarin Corporation plc
In U.S.: +1 (908) 892-2028
PR@amarincorp.com (media inquiries)

FAQ

What research will Amarin present at the ACC 2022 conference?

Amarin will present six posters on VASCEPA and VAZKEPA showcasing their cardiovascular benefits.

When is the ACC 2022 conference taking place?

The ACC 2022 conference will take place from April 2-4, 2022.

What are the main findings presented by Amarin at the ACC 2022?

The findings explore the effectiveness of icosapent ethyl in reducing cardiovascular risk, especially when combined with high-intensity statins.

Who is the CEO of Amarin and what is their stance on the research?

CEO Karim Mikhail expressed optimism about the expanding evidence base on icosapent ethyl's role for high-risk patients.

What are VASCEPA and VAZKEPA?

VASCEPA and VAZKEPA are prescription drugs containing icosapent ethyl, aimed at reducing cardiovascular risks.