– Data Further Advance Understanding of VASCEPA®/VAZKEPA® Potential Mechanism of Action and Utility as A Complementary Therapy for Residual Risk Reduction in Combination with Statins in Important Patient Sub-Categories –DUBLIN and BRIDGEWATER, N.J., March 31, 2025 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today highlighted key data presentations at ACC.25 showcasing the mechanistic activity of eicosapentaenoic acid (EPA) on lipoprotein(a) [Lp(a)]-enriched plasma and the effects of a glucagon-like peptide-1 (GLP-1) receptor agonist in combination with EPA on the expression of proteins in endothelial cells. “The data presented at ACC.25 continue to underscore the therapeutic value of icosapent ethyl (IPE) and EPA in potentially addressing known pathways of cardiovascular (CV) risk beyond LDL lowering for patients,” said R. Preston Mason, Ph.D., Brigham and Women’s Hospital. “While emerging therapeutic approaches are being explored to address residual CV risk, especially in patients with additional risk factors like obesity and elevated glucose levels, cardiovascular disease remains the world’s leading cause of death and we cannot afford to wait. High-risk patients must be treated now, using proven therapies that have consistently demonstrated their ability to reduce CV risk—on top of the standard of care, including statins. We already have effective treatments available, and it is imperative that we utilize them to reduce patients’ CV risk and save lives today. These learnings further advance understanding of how EPA and VASCEPA/VAZKEPA may be working to reduce CV events in at-risk patients.” The key findings are outlined below: More Rapid Oxidation of Lipoprotein(a) [Lp(a)]-enriched Plasma Compared to Small Dense- and Triglyceride-rich Lipoproteins is Limited by Eicosapentaenoic Acid (EPA) In this analysis, researchers analyzed rates of oxidation for Lp(a)-enriched plasma to other atherogenic particles, including enriched small dense LDL (sdLDL), LDL, or triglyceride (TG)-rich lipoproteins (VLDL) with and without the introduction of EPA at a pharmacologic concentration. An elevated Lp(a) level is known to increase CV risk. New data from this analysis show that EPA dose-dependently inhibited oxidation in all lipoproteins tested, especially Lp(a) enriched human plasma. This is an important finding as the potent inhibition of Lp(a) oxidation by EPA may contribute to the benefit observed in REDUCE-IT, including in those subjects with elevated Lp(a) levels as recently reported in this publication. Addition of Eicosapentaenoic Acid (EPA) to a GLP-1 Agonist Enhanced Expression of Detoxification Proteins in Endothelial Cells During Inflammation In Vitro In this mechanistic analysis, researchers evaluated the separate versus combined effects of EPA and GLP-1 receptor agonist liraglutide on expression of proteins in endothelial cells. We know there is clear evidence backing the benefits of EPA in reducing cardiovascular events in at-risk patients. However, with emerging therapeutic approaches to address residual cardiovascular risk there is added value in exploring the combination of proven therapies, in this case EPA and GLP-1 receptor agonist, with complementary or additive protective mechanisms that may potentially play a role in further reducing cardiovascular risk on top of the statin therapy. The combination of EPA and GLP-1 receptor agonist favorably modulated the expression of proteins associated with detoxifying reactive oxygen species under disease-like conditions. Recent Data Published in JAHA: REDUCE-IT Analysis Shows Clear VASCEPA/ VAZKEPA Outcomes Benefit in Patients with Well-Controlled LDL-C A recent post hoc analysis of REDUCE-IT was published in the Journal of the American Heart Association this past month evaluating the impact of icosapent ethyl on top of statin therapy in reducing cardiovascular events in at-risk patients with various baseline LDL-C levels, including those with well-controlled LDL-C (
Tag: Amarin
Amarin Reports Fourth Quarter Financial Results & Business Update and Announces Important Corporate Action
— Company Reports Fourth Quarter 2024 Total Revenues of $62.3 Million, Operating Expenses of $43.0 Million and Year End 2024 Cash Position of $294.2 Million — — Fourth Quarter and Full-Year 2024 Performance Reflects Benefits of Commitment to Strategic Focus, Operational Streamlining, Prudent Cash Management, and Growing Global Momentum of VASCEPA®/VAZKEPA® (icosapent ethyl) Franchise — — Announces 1-For-20 ADS Ratio Change to Maintain Nasdaq Listing — — Company to Host Conference Call Today at 8:00 a.m. EDT — DUBLIN and BRIDGEWATER, N.J., March 12, 2025 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), today announced financial results for the fourth quarter of 2024 and provided a review of fourth quarter and recent operational highlights. “Since taking on the role of CEO of Amarin last year, I have worked with our leadership team and the Board of Directors to identify opportunities to leverage our unique assets, skills and resources to drive value,” said Aaron Berg, President & CEO, Amarin. “In 2024, while still progressing with the early launch in markets outside the U.S. and despite a dynamic generic market in the U.S., we generated more than $200 million in revenue and ended the year with nearly $300 million in cash and no debt — all measures exemplifying the strength and resilience of our franchise and the impact of our disciplined approach to capital deployment. Specifically, we continued to capture efficient branded revenue in the U.S. market for VASCEPA, unlocked access to VASCEPA/VAZKEPA in six additional global markets — including Italy, China and Australia — both on our own and through partnerships, and progressed in an additional 16 countries at various stages towards commercialization. The global VASCEPA franchise remains poised to continue expanding its impact on cardiovascular disease for at-risk patients worldwide.” In addition, Aaron Berg commented, “Building on our efforts and results in 2024, we continue to identify steps to advance the company. As a publicly traded company, there is considerable value in maintaining our Nasdaq listing. To this effect, today we announced our intent to initiate a ratio change to our ADS program.” 1-For-20 ADS Ratio Change In a separate press release issued today, the Company announced its intent to effect a Ratio Change on its American Depositary Shares (“ADS”) from one (1) ADS representing one (1) ordinary share, to the new ratio of one (1) ADS representing twenty (20) ordinary shares (the “Ratio Change”). The effective date of the Ratio Change is expected to be on or about April 11, 2025. The objective of the Ratio Change is to maintain the Company’s listing on the Nasdaq Capital Market and to preserve the Company’s long-term access to the equity capital markets. For further information, please refer to the press release issued on March 12, 2025. Additional questions and answers regarding the Ratio Change can be found under the Investor Relations section of Amarin’s corporate web site here: https://cms.amarincorp.com/sites/default/files/2025-03/e6713d4c-9083-4623-a9e9-6b13d8a4201b.pdf Fourth Quarter 2024 & Recent Operational Highlights The Company continued to advance commercialization and pricing and reimbursement efforts across European markets: In all European countries where VAZKEPA has launched, in-market demand grew in the fourth quarter versus the third quarter of 2024.In Italy, the Company secured national reimbursement. Access has already been unlocked in 9 (of 21) regions of this EU5 market, representing more than 50% of the total VAZKEPA eligible population. Based on recent scientific leader feedback, the appetite for the product is very strong across all regions in Italy.In Austria, national reimbursement for VAZKEPA was secured in late February; as of April 1, 2025, VAZKEPA will be included in Austria’s Code of Reimbursement (EKO). Through partnerships, the Company continues to make progress towards regulatory approvals, access and commercialization in Rest of World (RoW) markets: Two of our partners launched in cardiovascular risk reduction, EddingPharm in China and CSL Seqirus in Australia.While early in the launch phase for a number of RoW markets, all partners saw growth in demand for VASCEPA/VAZKEPA in the fourth quarter.Amarin and its partners are continuing to advance regulatory processes in seven additional RoW markets. The Company’s R&D Team and other investigators have continued to generate, present and publish important new data which add to the significant body of evidence demonstrating the unique benefits of VASCEPA/VAZKEPA. In 2024, a total of 45 additional publications including abstracts, posters, and manuscripts were presented or published that, both individually and in aggregate, helped to advance an ever-broadening understanding of the science and value of icosapent ethyl and EPA. In 2024, investigators presented additional subgroup analyses from the landmark REDUCE-IT® cardiovascular outcomes trial in patients with and without coronary artery disease (CAD) history and data on the mechanistic effects of eicosapentaenoic acid (EPA), including its antioxidant effects in endothelial cells and the ability of EPA to impact the oxidation of Lp(a) particles made of protein and fats (lipids) that carry cholesterol through the bloodstream, at the American Heart Association (AHA) Scientific Sessions. The medical community has increased its focus on Lp(a) as a key cardiovascular risk factor.A recent post hoc analysis of REDUCE-IT published in the Journal of the American Heart Association evaluated the impact of icosapent ethyl on patients with various LDL-C levels at baseline, including those with very well-controlled LDL-C (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.medicines.org.uk/emc/product/12964/smpc. Globally, prescribing information varies; refer to the individual country product label for complete information. Use of Non-GAAP Adjusted Financial Information Included in this press release are non-GAAP adjusted financial information as defined by U.S. Securities and Exchange Commission Regulation G. The GAAP financial measure most directly comparable to each non-GAAP adjusted financial measure used or discussed, and a reconciliation of the differences between each non-GAAP adjusted financial measure and the comparable GAAP financial measure, is included in this press release after the condensed consolidated financial statements. Non-GAAP adjusted net (loss) income was derived by taking GAAP net loss and adjusting it for non-cash stock-based compensation expense, restructuring expense and other one-time expenses. Management uses these non-GAAP adjusted financial measures for internal reporting and forecasting purposes, when publicly providing its business outlook, to evaluate the company’s performance and to evaluate and compensate the company’s executives. The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations. While management believes that these non-GAAP adjusted financial measures provide useful supplemental information to investors regarding the underlying performance of the company’s business operations, investors are reminded to consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the company’s results of operations as determined in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP measures used by other companies, and management may utilize other measures to illustrate performance in 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 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, including statements regarding Amarin’s planned ratio adjustment and its potential impact on the ADS trading price and on liquidity of the ADSs, as well as Amarin’s ability to regain compliance with Nasdaq’s minimum bid price requirement and other continued listing requirements. 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 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. 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 (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. 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, as amended or the Securities and Exchange Act of 1934, as amended. Amarin Contact Information Investor & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com -Tables to Follow- CONSOLIDATED BALANCE SHEET DATA(U.S. GAAP)Unaudited * December 31, 2024 December 31, 2023 (in thousands)ASSETS Current Assets: Cash and cash equivalents$121,038 $199,252 Restricted cash 300 525 Short-term investments 173,182 121,407 Accounts receivable, net 122,279 133,563 Inventory 166,048 258,616 Prepaid and other current assets 12,552 11,618 Total current assets 595,399 724,981 Property, plant and equipment, net 16 114 Long-term inventory 64,740 77,615 Operating lease right-of-use asset 7,592 8,310 Other long-term assets 1,213 1,360 Intangible asset, net 16,389 19,304 TOTAL ASSETS$685,349 $831,684 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable$40,366 $52,762 Accrued expenses and other current liabilities 139,583 204,174 Current deferred revenue — 2,341 Total current liabilities 179,949 259,277 Long-Term Liabilities: Long-term deferred revenue — 2,509 Long-term operating lease liability 7,723 8,737 Other long-term liabilities 11,501 9,064 Total liabilities 199,173 279,587 Stockholders’ Equity: Common stock 305,298 302,756 Additional paid-in capital 1,914,750 1,899,456 Treasury stock (65,326) (63,752)Accumulated deficit (1,668,546) (1,586,363)Total stockholders’ equity 486,609 552,097 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$685,349 $831,684 * Unaudited as a standalone schedule; copied from consolidated financial statements CONSOLIDATED STATEMENTS OF OPERATIONS DATA(U.S. GAAP)Unaudited * Three Months Ended December 31, Year Ended December 31, (in thousands, except per share amounts) (in thousands, except per share amounts) 2024 2023 2024 2023 Product revenue, net$60,068 $70,555 $204,590 $285,299 Licensing and royalty revenue 2,238 4,158 24,024 21,612 Total revenue, net 62,306 74,713 228,614 306,911 Less: Cost of goods sold 35,399 29,589 110,758 102,142 Less: Cost of goods sold – restructuring inventory 36,474 — 36,474 39,228 Gross margin (9,567) 45,124 81,382 165,541 Operating expenses: Selling, general and administrative (1) 36,970 43,941 152,310 199,938 Research and development (1) 5,985 5,791 20,869 22,219 Restructuring — 229 — 10,972 Total operating expenses 42,955 49,961 173,179 233,129 Operating loss (52,522) (4,837) (91,797) (67,588)Interest income 3,371 3,419 13,403 11,863 Interest expense (3) (2) (7) (8)Other (expense) income, net (753) (1,029) 1,201 2,063 Loss from operations before taxes (49,907) (2,449) (77,200) (53,670)Benefit from (provision for) income taxes 1,289 (3,332) (4,983) (5,442)Net loss$(48,618) $(5,781) $(82,183) $(59,112)Loss per share: Basic$(0.12) $(0.01) $(0.20) $(0.15)Diluted$(0.12) $(0.01) $(0.20) $(0.15)Weighted average shares outstanding: Basic 411,293 408,485 410,937 407,655 Diluted 411,293 408,485 410,937 407,655 * Unaudited as a standalone schedule; copied from consolidated financial statements(1)Excluding non-cash stock-based compensation, selling, general and administrative expenses were $138,144 and $187,445 for the years ended December 31, 2024 and 2023, respectively, and research and development expenses were $17,330 and $18,032, respectively, for the same periods. RECONCILIATION OF NON-GAAP NET (LOSS) INCOMEUnaudited Three months ended December 31, Year Ended December 31, (in thousands, except per share amounts) (in thousands, except per share amounts) 2024 2023 2024 2023 Net (loss) income for EPS – GAAP$(48,618) $(5,781) $(82,183) $(59,112)Stock-based compensation expense 3,400 4,646 17,703 16,680 Restructuring Inventory 36,474 — 36,474 39,228 Restructuring expense — 229 — 10,972 Advisor Fees — — — 6,270 Adjusted net (loss) income for EPS – non-GAAP$(8,744) $(906) $(28,004) $14,038 Basic and diluted (Loss) earnings per share: Basic – non-GAAP$(0.02) $(0.00) $(0.07) $0.03 Diluted – non-GAAP$(0.02) $(0.00) $(0.07) $0.03 Weighted average shares: Basic 411,293 408,485 410,937 407,655 Diluted 411,293 408,485 410,937 422,966
Investigators to Present New REDUCE-IT Subanalysis of VASCEPA®/VAZKEPA® (icosapent ethyl) in Patients With and Without Coronary Artery Disease History and Mechanistic Data on Eicosapentaenoic Acid (EPA) at the American Heart Association’s (AHA) Annual Scientific Sessions
DUBLIN and BRIDGEWATER, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that investigators will present an additional subgroup analysis from the landmark REDUCE-IT outcomes trial in patients with and without coronary artery disease (CAD) history and mechanistic data on eicosapentaenoic acid (EPA) at the American Heart Association’s Scientific Sessions, November 16-18, 2024 in Chicago, IL.
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 Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal
— Portuguese Ministry of Health approves VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular (CV) events in patients with established cardiovascular disease (CVD)1 — — Approval marks eighth national reimbursement of VAZKEPA® in Europe —
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