Tag: Amarin

Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 22, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced new supported and/or funded subgroup data from the landmark REDUCE-IT® cardiovascular outcomes trial with VASCEPA®/VAZKEPA® (icosapent ethyl), as well as abstracts showcasing the mechanistic activity of eicosapentaenoic acid (EPA) that will be presented at the European Society of Cardiology (ESC) Congress in London, United Kingdom, August 30 – September 2, 2024.

Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024

DUBLIN and BRIDGEWATER, N.J., July 17, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that it will host a conference call with Aaron Berg, President & CEO, and members of Amarin’s senior management team to discuss its second quarter 2024 results followed by Q&A on Wednesday, July 31st, 2024, at 8:00 a.m. ET. The conference call with management will follow the release of the Company’s second quarter 2024 financial results in the pre-market hours on July 31st.   To enhance engagement with the company’s shareholder base and facilitate connections with its investors, Amarin is partnering with Say Technologies to allow shareholders to submit and upvote questions, a selection of which will be answered by Amarin management during the earnings call.  Starting on July 17th at 8:00 am ET, all shareholders are encouraged to submit questions by visiting: https://app.saytechnologies.com/amarin-2024-q2. This Q&A platform will remain open until 24 hours prior to the start of the earnings call. Shareholders can email support@saytechnologies.com for any support inquiries. Conference Call and Webcast Information:  Access to the live call: Go to the investor relations section of the Company’s website at www.amarincorp.com Dial in within the United States: 888-506-0062International dial in: 973-528-0011Access Code: 409616Access to replay: Dial in within the United States: 877-481-4010 International dial in: 919-882-2331  Access Code: 50766A replay of the call will also be available through the Company’s website shortly after the call.  About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. 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.    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 (http://www.amarincorp.com/investor-relations), 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 & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.comInvestor.relations@amarincorp.com

Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

— VASCEPA Approved by the National Medical Products Administration (NMPA) To Reduce the Risk of Cardiovascular Events as an Adjunct to Statin Therapy in Adult Patients with Elevated Triglyceride (TG) Levels (≥150 mg/dL) and Other High-Risk Characteristics as Studied in REDUCE-IT — — EddingPharm Now Working to Prepare for National Reimbursement and Drug Listing (NRDL) and Enhance the Commercial Launch of VASCEPA Across Mainland China — DUBLIN and BRIDGEWATER, N.J., July 08, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in Mainland China (“China”), EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated and high triglycerides (≥150mg/dL) and established cardiovascular disease or diabetes mellitus with ≥2 other cardiovascular disease risk factors, combined with hypertriglyceridemia. Following approval by NMPA, EDDING is working to include VASCEPA on the National Reimbursement Drug Listing (NRDL) and augment the ongoing commercial launch of VASCEPA in China to include the CVRR indication. The NRDL is updated annually and serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. Inclusion on the NRDL provides full or partial reimbursement at the national level. Products included in this listing can be prescribed from public hospitals in China. According to a recent report on cardiovascular health and disease in China,i cardiovascular disease (CVD) accounted for 44-47% of all death in urban and rural areas in China, meaning two out of every five deaths were due to CVD. It is estimated that 330 million patients suffer from CVD in China,i and that China has one of the highest CVD death rates in the world.ii According to the World Heart Federation, cardiovascular events, such as ischemic heart disease and stroke, are projected to increase by 50 percent among the population in China between 2010 and 2030 (based on population aging and growth alone).ii “We congratulate our partner, EDDING, on the regulatory approval of VASCEPA for cardiovascular risk reduction in China, as this marks an important step in helping broaden access to this novel treatment for patients across that country,” said Steven Ketchum, Ph.D., President, Research & Development and Chief Scientific Officer, Amarin. “This milestone is a major step forward to help ensure that the unique benefits of VASCEPA are accessible to patients throughout the world. We look forward to EDDING’s continued progress in introducing VASCEPA to patients at-risk for a cardiovascular event across China.” “The approval of the CVRR indication will allow many patients with atherosclerotic disease (ASCVD) in China to benefit from this innovative drug,” said EDDING. “In the future, we will continue to expand the application of VASCEPA® in the management of cardiovascular diseases to meet the unmet clinical needs of more Chinese patients.” As part of the approval, NMPA has requested that EDDING conduct a post-approval study after the product is marketed to further verify the efficacy of the product to reduce the risk of cardiovascular events in Chinese patients and provide a post-approval study report to conduct a life-cycle benefit-risk assessment at the time of product renewal. Product renewal is required five years post the approval of the product. Under the partnership agreement, EDDING is responsible for development and commercialization activities in the China territory and associated expenses. Amarin provides development assistance and is responsible for supplying finished bulk product. Based upon the NMPA approval for the CVRR indication, Amarin will earn a regulatory milestone payment in the amount of $15 million. EDDING will also pay Amarin tiered double-digit percentage royalties on net sales of VASCEPA in the territory. Amarin will supply product to EDDING under negotiated supply terms. 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 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, Spain, 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 CAN BE FOUND AT WWW.VASCEPA.COM.  Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here.  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 the regulatory approval of VASCEPA in China and the potential impact in that territory; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA 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 2022. 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 (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 Media & Investor Inquiries:  Mark Marmur Amarin Corporation plc   PR@amarincorp.com ______________________________ i The Writing Committee of the Report on Cardiovascular Health and Diseases in China. Report on Cardiovascular Health and Diseases in China 2021: An Updated Summary[J]. Biomedical and Environmental Sciences, 2022, 35(7): 573-603. doi: 10.3967/bes2022.079ii World Heart Federation Fact Sheet: Cardiovascular Disease in China. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://world-heart-federation.org/wp-content/uploads/2017/05/Cardiovascular_diseases_in_China.pdf

Amarin Board of Directors Announces CEO Transition

— Board Appoints Aaron Berg as President & CEO — — Patrick Holt to Step Down as President & CEO to Pursue Other Opportunities — DUBLIN and BRIDGEWATER, N.J., June 04, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company’s Board of Directors has appointed Aaron Berg, currently Amarin’s Executive Vice President and President of the U.S. Business, as President and Chief Executive Officer (CEO). The appointment of Mr. Berg follows the resignation of Patrick Holt as President & CEO of the Company. “On behalf of the Company’s Board of Directors, I thank Pat for his contributions to Amarin, and I welcome working closely again with Aaron as President & CEO,” said Odysseas Kostas, MD, the Chairman of the Board. “No one knows the company better than Aaron, and we look forward to him contributing meaningfully as CEO.” “As I begin this new role, my focus is clear – to find ways to deliver value for investors, and to maximize the potential of VASCEPA®/VAZKEPA for patients,” said Aaron Berg, President & CEO, Amarin. “I look forward to continuing to work with our Board of Directors and our tremendous team focusing on these priorities for the Company as we move forward.” Mr. Berg joined Amarin in November 2012 and has more than 30 years of biopharmaceutical industry experience. Mr. Berg initially served as Amarin’s Vice President, Marketing and Managed Care. He was promoted to Senior Vice President, Marketing and Sales in February 2014, and to the position of Senior Vice President and Chief Commercial Officer in April 2018. Before joining Amarin, Mr. Berg served as President and Chief Executive Officer for Essentialis, Inc., a development stage pharmaceutical company where he led the company’s work on triglyceride management. Prior to joining Essentialis, Mr. Berg served as Vice President of Marketing and Sales at Kos Pharmaceuticals (Kos), where he was instrumental in driving annual revenues approaching $1 billion. Mr. Berg worked at Kos until it was acquired by Abbott Laboratories in December 2006 for $3.7 billion. 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.   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 the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and  potential population health impact, as well as general beliefs 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 2023. 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 (amarincorp.com/investor-relations), 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.    Availability of Other Information About Amarin 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 (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, U.S. 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 & Media Inquiries:    Mark Marmur  Amarin Corporation plc    PR@amarincorp.com 

 Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.

— Greek Ministry of Health approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce cardiovascular risk in statin-treated adult patients with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and other high-risk characteristics as studied in REDUCE-IT1 — — Approval marks seventh national reimbursement of VAZKEPA® in Europe — — Vianex S.A., one of the leading pharmaceutical companies in Greece, will commercialize VAZKEPA® as Amarin’s exclusive distributor in the country — DUBLIN, Ireland and BRIDGEWATER, N.J., May 28, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announces that the Greek Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1. As in most European countries, cardiovascular diseases are the main cause of death in Greece2. Today’s approval – which marks the seventh national reimbursement of VAZKEPA® in Europe – provides eligible patients across Greece access to a new treatment option to reduce their cardiovascular risk and help improve their overall heart health. “We are very pleased with this seventh national reimbursement for VAZKEPA® supporting our continued growth opportunity in Europe which is a testament to the strength of our scientific data and the value of our product for patients at-risk for a cardiovascular event,” said Patrick Holt, President & CEO of Amarin. To support the commercialization of VAZKEPA® in Greece, Amarin has entered into an exclusive agreement with Vianex S.A., one of the leading pharmaceutical companies in Greece celebrating its 100-year anniversary this year. Under the terms of the agreement, Vianex S.A. will be the sole and exclusive distributor of VAZKEPA® in the territory to import, register, distribute and commercialize the product. Amarin will be responsible for supplying finished product to Vianex at a transfer price paid to Amarin. Vianex will start commercializing VAZKEPA® in the course of the next weeks. Christos Papadopoulos, Senior Vice President and Head of Commercial Europe at Amarin, commented: “We look forward to working with Vianex in bringing our VAZKEPA® treatment to healthcare providers and patients across Greece. As one of the country’s leading pharmaceutical companies, Vianex has strong commercial capabilities and deep expertise in cardiology and cardiovascular risk management. Their capabilities and experience align well with the opportunity to successfully commercialize VAZKEPA® and its proven ability to reduce cardiovascular risk and improve outcomes for patients.” 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 VIANEX S.A. VIANEX S.A.  is a Greek pharmaceutical company, founded in 1971 by the Giannakopoulos’ family that has been involved with the pharmaceutical industry since 1924.  Through its 100-year history, VIANEX produces, imports, markets, packages and distributes a large number of pharmaceuticals, covering various therapeutic classes. It has formed strategic partnerships and alliances with major pharmaceutical entities across the globe. VIANEX owns four state-of-the-art fully specialized Manufacturing Plants that guarantee outstanding production capabilities. It covers the entire spectrum of manufacturing activities while it continuously upgrades the range of services by investing in technological equipment. VIANEX has also been exporting registered products for over 20 years in 114 countries worldwide and is an approved supplier of the World Health Organization. Strategic planning, focus to quality, operational excellence and long-term experience have contributed to a leading position in the Greek Pharmaceutical market, based on a long-term effort, that passes from generation to generation and constantly focuses to the future. 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 the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and  potential population health impact, as well as general beliefs 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 2023. 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 (https://amarincorp.com/investor-relations), 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 & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com 1 https://www.moh.gov.gr/articles/times-farmakwn/epitroph-aksiologhshs-kai-apozhmiwshs-farmakwn/12338-entaksh-farmakwn-ston-katalogo-apozhmioymenwn-farmakwn?fdl=270532 European Commission – Greece Country Health Profile 2023 – access May 2024

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

Citizen Petition Spotlights Risks for Patients on Drug Proven to Have No Benefit in Improving Cardiovascular Outcomes and Need for Urgent Regulatory Action to Protect Patients Citizen Petition Spotlights Risks for Patients on Drug Proven to Have No Benefit in Improving Cardiovascular Outcomes and Need for Urgent Regulatory Action to Protect Patients

Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo

— Subgroup Analyses from REDUCE-IT® and Mechanistic Data on Icosapent Ethyl(IPE)/Eicosapentaenoic Acid (EPA) Featured at the Meeting —    DUBLIN, Ireland and BRIDGEWATER, N.J., March 25, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that additional patient subgroup analyses from the landmark REDUCE-IT outcomes trial and mechanistic data on icosapent ethyl (IPE)/eicosapentaenoic acid (EPA) will be presented at the American College of Cardiology’s Annual Scientific Session & Expo, April 6 – 8, 2024 in Atlanta, GA. “The data being featured at ACC.24 continues to support and explain the clinical utility and value of VASCEPA®/VAZKEPA® (icosapent ethyl), not only in the overall REDUCE IT patient population, but in the different sub-populations analyzed so far,” said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer, and Head of Global Medical Affairs at Amarin “The data highlight VASCEPA/VAZKEPA’s effect on reducing MACE in patients with different baseline levels of Lipoprotein(a) [Lp(a)] including among those with clinically relevant Lp(a) elevation as well as among patients with high and low LDL-C baseline levels. These data demonstrate the molecule’s impact in reducing patients’ residual cardiovascular event risk across these patient sub-groups regardless of their baseline Lp(a) or LDL-C levels. Additionally, the meeting provides an opportunity to highlight further evidence regarding the potential mechanistic activity of EPA in reducing cardiovascular events in at-risk patients.” “This latest research reaffirms Amarin’s commitment to advancing cardiovascular care and should help further advance the medical community’s understanding of the role, the value and the potential mechanism of action of VASCEPA/VAZKEPA to reduce cardiovascular events in at-risk patients globally,” concluded Abadir. Featured Amarin-supported abstracts to be presented by international academic collaborators at ACC Scientific Sessions 2024 include: Moderated Poster Presentations Icosapent Ethyl Reduces MACE in Patients with Elevated Triglycerides and High or Low Lipoprotein(a) Concentrations: A REDUCE-IT SubanalysisMichael Szarek, Deepak L. Bhatt, Elliot A. Brinton, Michael Miller, et al.–Available April 6th, 3:30-3:40 PM-Moderated Poster Theater 06 Efficacy of Icosapent Ethyl for Reducing Cardiovascular Outcomes by Baseline Low Density Lipoprotein Cholesterol LevelRahul Aggarwal, Deepak L. Bhatt, Philippe Gabriel Steg, Michael Miller, et al.-Available Apil 6th, 12:15-12:25 PM-Moderated Poster Theater 08 Eicosapentaenoic Acid (EPA) Inhibits Lipoprotein(a) [Lp(a)] Oxidation due to Scavenging Mechanisms in VitroSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 9:30-9:40 AM-Moderated Poster Theater 06 Poster Presentations Eicosapentaenoic Acid (EPA) and a High Intensity Statin Enhanced Expression of Proteins for Detoxification of Reactive Oxygen Species During Angiotensin II Challenge in Endothelial CellsSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 1:15-2:00 PM-Hall B4-5 Eicosapentaenoic Acid and Rosuvastatin Modulate Expression of Endothelial Proteins that Regulate Function and Platelet Activity During Angiotensin II StimulationSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 1:15-2:00 PM-Hall B4-5 Effects of Icosapent Ethyl on Vascular Regenerative Cells in Individuals with Elevated Triglycerides: Insights From the IPE-Prevention Cardiolink-14 TrialEhab Bakbak, Aishwarya Krishnaraj, Deepak L. Bhatt, Brady Park, et al.–Available April 8th, 12:45-1:30 PM- Hall B4-5 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 RiskCardiovascular 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.1  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%.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 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 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, 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. 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, Denmark, Finland, Austria, the UK, Spain and the Netherlands.   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 click here.   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 the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs 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 2023. 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 & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.comInvestor.relations@amarincorp.com 1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 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.