Olezarsen Sodium

DUBLIN and BRIDGEWATER, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a company advancing the science of cardiovascular therapeutics worldwide, today commented on recent innovations in therapies for patients with elevated triglycerides (TG) and shared its perspective on how these developments stand to shape patient access and treatment strategies. Specifically, new therapies for these patients are likely to expand the use of existing, proven options over time, including Amarin’s VASCEPA®/VAZKEPA® (icosapent ethyl), an effective, safe, oral therapy that has been prescribed more than 25 million times to patients globally. In addition, through its approved indication for severe hypertriglyceridemia (sHTG), which is defined as TG ≥500 mg/dL, as well as strong clinical evidence, affordability, and broad reimbursement, VASCEPA/VAZKEPA aligns with current payor-driven step therapy programs, which require patients to try existing safe and efficacious treatment options before newer, more expensive sHTG alternatives. Celebrating Scientific Advancement Amarin applauds the groundbreaking work addressing sHTG and rare genetic disorders such as familial chylomicronemia syndrome (FCS). These advances help drive patient-doctor interactions and bring critical attention to patients with very high triglyceride levels, which has been shown to increase risk for pancreatitis. Aaron Berg, President and CEO of Amarin, stated: “Innovative therapeutics coupled with related FDA breakthrough therapy designations, underscore the renewed focus on recognizing and treating the risks in patients with elevated triglycerides. VASCEPA has been approved in the US to reduce triglycerides in patients with sHTG. VASCEPA/VAZKEPA has also been approved for cardiovascular risk reduction (CVRR) in over 50 countries and recognized for CVRR by more than 70 global medical societies and is therefore uniquely positioned to complement our industry’s progress and deliver further meaningful impact to patients worldwide. “ VASCEPA/VAZKEPA: Significantly Reducing Cardiovascular Events in a Global Population of High-Risk Patients The emergence of new ApoC-III–targeted injectables is a major step forward for patients, delivering transformative benefits for those at highest risk. Yet, beyond this small group of sHTG patients, there remains an unmet need among tens of millions of cardiovascular disease (CVD) patients worldwide above 150 mg/dL i who urgently need proven therapies to reduce their risk of a cardiovascular event. VASCEPA is FDA approved as an adjunct to diet to reduce TG levels in adult patients with sHTG. VASCEPA is also approved 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 TG levels. Based on the landmark results of the Company’s cardiovascular outcomes trial, REDUCE-IT, published in 2018, which included 8,179 patients, relative to placebo VASCEPA demonstrated a 25% decrease in cardiovascular (CV) events when used as an adjunct to statin therapy in patients with elevated TG levels. ii While the effect of VASCEPA on the risk of pancreatitis in patients with sHTG has not been determined, data from the Company’s pivotal MARINE study in patients with TGs between 500 and 2,000 mg/dL, published in 2011, demonstrated that approximately 50% of those treated orally with VASCEPA 4g/day achieved TG levels below 500 mg/dL at week 12. iii , iv Importantly, the reduction in TG levels observed with VASCEPA in the MARINE study was not associated with elevations in low-density lipoprotein cholesterol (LDL-C) levels relative to placebo, unlike other older and newer TG-lowering agents. v , vi , vii Elevated LDL-C is a well-established major CV risk factor. Unlike other TG-lowering agents such as fibrates, niacin and mixed omega-3 products, which have failed in prior cardiovascular outcomes trials, and unlike newer TG-lowering agents targeting ApoC-III protein, which have not yet been studied for cardiovascular outcomes, VASCEPA has already demonstrated robust efficacy in reducing CV events when added on top of statin therapy in the REDUCE-IT cardiovascular outcomes study. In 2025, Amarin further expanded the potential global reach of its VASCEPA/VAZKEPA franchise by securing an exclusive long-term license and supply agreement with Recordati S.p.A. to commercialize VAZKEPA across 59 countries, focused on Europe where patent protection extends until 2039. VASCEPA/VAZKEPA is now commercially available in more than 20 countries. Payor Driven Step-Therapy Programs Likely to Result in Broader Use of VASCEPA/VAZKEPA to Treat sHTG U.S. payors have already implemented step-therapy programs for new ApoC-III injectables within the currently approved FCS indications. viii , ix This could result in increased utilization of existing drugs such as VASCEPA over time via their designation as a payor-preferred, first-line therapy prior to access to the newer, higher cost ApoC-III therapies. A relevant, recent comparison is the 2015 launch of premium priced PCSK9 inhibitors, during which U.S. payors implemented step-therapy requirements that drove significant growth for ezetimibe (also used to lower LDL or “bad” cholesterol). Despite a declining market in the years prior to PCSK9 inhibitors launch, over the past eight years, ezetimibe prescriptions have experienced sustained growth, averaging approximately 15% annually. x Taking into consideration both the PCSK9 inhibitors comparison and current step-therapy requirements for ApoC-III therapies, as treatable patient populations expand for ApoC-III therapies via future FDA approvals (e.g. sHTG), these financially driven payor requirements for ApoC-III therapies may increase demand and utilization of clinically proven, FDA-approved, cost-effective and broadly reimbursed agents, such as VASCEPA/VAZKEPA. 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 health 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 close to 100 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 Great Britain (applying to England, Scotland and Wales). 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: 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; our belief in the potential for the expanded use of VASCEPA/VAZKEPA and 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 ( ), the investor relations website ( ) including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. Availability of Other Information About Amarin Amarin communicates with its investors and the public using the company website ( ) and the investor relations website ( investors.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 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 i Fan W, Philip S, Granowitz C, Toth PP, Wong ND. Prevalence of US Adults with Triglycerides ≥ 150 mg/dl: NHANES 2007-2014. Cardiol Ther. 2020;9(1):207-213. ii Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med . 2019;380(1):11-22. doi:10.1056/NEJMoa1812792 iii Bays HE, et al. Am J Cardiol. 2011;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015. iv Chowdhury IN. Medical Review(s): Vascepa (Icosapent Ethyl) . Silver Spring, MD: US Food and Drug Administration; 2012:50. Application No. 202057Orig1s000. Accessed December 17, 2025. v vi vii Marston NA, Bergmark BA, Alexander VJ, et al.; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for managing severe hypertriglyceridemia and pancreatitis risk. N Engl J Med. 2025 Nov 8. doi: 10.1056/NEJMoa2512761. viii ix x Symphony METYS data on file. Accessed December 2025.