Latest Clinical Research Evaluating VASCEPA® (Icosapent Ethyl) in Patients with Residual Cardiovascular Risk to be Presented at ESC Congress 2020, the Annual Meeting of the European Society of Cardiology

Amarin-Supported Research and Analyses from Academic Collaborators to Be Featured in Five Presentations, Including Late-Breaking Science Presentation of Final EVAPORATE Study Results

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that new data that add to the growing body of knowledge on VASCEPA^® (icosapent ethyl) in patients at risk for major adverse cardiovascular events will be presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology (ESC), being held virtually from August 29 - September 1, 2020. These new findings will be presented in one Late-Breaking Science presentation and four rapid fire abstract and e-poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.    

“Cardiovascular disease is an ever-increasing global challenge commanding both attention and action,” said Craig Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief medical officer. “Often devastating, cardiovascular disease demands new research to increase our understanding of how to address residual cardiovascular risk. Several scheduled presentations at ESC provide new data on VASCEPA and its potential to address heart health in at-risk patients.”

Featured Amarin-supported abstracts to be presented at ESC Congress 2020 include:

Late-Breaking Science Presentation

• Session: Late-Breaking Science in Lipids
  “Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final results of the EVAPORATE Study” – presented on behalf of all authors by Matthew Budoff, M.D., The Lundquist Institute – August 29, 8:50-9:20 a.m. CEST (Central European Summer Time)

Rapid Fire Abstracts and e-Poster Presentations

• Session: Rapid Fire Abstracts
  “REDUCE-IT: Accumulation of Data Across Prespecified Interim Analyses to Final Results” – presented on behalf of all authors by Brian Olshansky, M.D., University of Iowa  –  Available from August 30
• Session: Rapid Fire Abstracts
  “REDUCE-IT: Total Ischemic Events Reduced Across the Full Range of Baseline LDL Cholesterol and Other Key Subgroups” – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital – Available from August 30
• Session: Rapid Fire Abstracts
  “Are the Results of Clinical Trials Relevant in The Real World? The Applicability of REDUCE-IT to the FAST-MI Registry.” – presented on behalf of all authors by Jean Ferrières, M.D., M.Sc., FESC, Toulouse Rangueil University Hospital – Available from August 30
• Session: e-Poster
  “REDUCE-IT: Outcomes by Baseline Statin Type” – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital – Available from August 28

Additional REDUCE-IT® and icosapent ethyl (EPA)-related topics will be presented at ESC Congress 2020 and can be found at https://www.escardio.org/Congresses-&-Events/ESC-Congress.

About Amarin
Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA^® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, Europe and the Middle East. For more information about Amarin, visit www.amarincorp.com.

About Cardiovascular Risk
The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.¹ In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.

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%.² 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.^3,4,5

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.⁶ The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.⁷ The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.⁸ These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.

About VASCEPA^® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. 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 eight million times. VASCEPA is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019.

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.

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:

Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.