Aspirin

The opinion will now be referred to the European Commission for final regulatory decision on donanemab INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers. The European Commission is expected to make a regulatory decision on donanemab in the coming months. "This positive opinion marks a significant milestone in our efforts to bring donanemab to eligible patients across Europe," said Patrik Jonsson, executive vice president and president of Lilly International. "Donanemab has the potential to make a meaningful difference for people living with early symptomatic Alzheimer's disease, and Lilly remains committed to advancing the science through ongoing clinical trials and programs." Alzheimer's disease currently affects as many as 6.9 million people in Europe, with this figure expected to almost double by 2050 as aging populations continue to increase.1-2 Approximately one-third of individuals with mild cognitive impairment or mild dementia due to Alzheimer's disease progress to the next clinical stage of disease in one year.3 The positive opinion was primarily based on clinical trial data from the TRAILBLAZER-ALZ 2 clinical trial demonstrating that donanemab significantly slowed cognitive and functional decline and reduced the risk of progressing to the next clinical stage of disease, as well as the TRAILBLAZER-ALZ 6 clinical trial which evaluated a modified titration dosing schedule.4 In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the dosing schedule used in TRAILBLAZER-ALZ 2 at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/ hemosiderosis (ARIA-H) are side effects within the class of therapies that do not usually cause any symptoms, but serious and life-threatening symptoms can occur. ARIA can be fatal. Carriers of one or two copies of the ApoE4 gene may be at higher risk of developing Alzheimer's disease and experiencing ARIA. Patients should discuss any safety concerns with their healthcare providers. About Kisunla Donanemab, a monthly infusion, is currently marketed as Kisunla in the United States and other countries, including Japan, China, United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore*, Taiwan, Brazil, Mexico and Australia. In the United States, Japan, China and many other countries, donanemab is approved for patients regardless of ApoE4 status. Donanemab is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.5-8 U.S. INDICATION AND SAFETY SUMMARY WITH WARNINGS Kisunla™ (kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease. Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headaches, dizziness, nausea, difficulty walking, confusion, vision changes and seizures. Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk. Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above. There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion. Other common side effects Headache Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or . Before you receive Kisunla, tell your healthcare provider: About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby. How to receive Kisunla Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes. Learn more For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com. This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you. DN CON BS APP Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a potential treatment for people with early symptomatic Alzheimer's disease, and regulatory approval and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer's disease continuum. Alzheimer's & Dementia. 2023;19:658-670. . Alzheimer Europe. Prevalence of dementia in Europe. Available at: . Potashman M, Buessing M, Levitchi Benea M, et al. Estimating progression rates across the spectrum of Alzheimer's disease for amyloid-positive individuals using national Alzheimer's coordinating center data. Neurol Ther. 2021;10(2):941-953. doi:10.1007/s40120-021-00272-1 Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239. Boustani M, Doty EG, Garrison LP Jr, et al. Assessing the Cost-effectiveness of a Hypothetical Disease-modifying Therapy With Limited Duration for the Treatment of Early Symptomatic Alzheimer Disease. Clin Ther. 2022;44(11):1449-1462. doi:10.1016/j.clinthera.2022.09.008. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239. Ross EL, Weinberg MS, Arnold SE. Cost-effectiveness of Aducanumab and Donanemab for Early Alzheimer Disease in the US. JAMA Neurol. 2022;79(5):478-487. doi:10.1001/jamaneurol.2022.0315. Mattke S, Ozawa T and Hanson M. Implications of Treatment Duration and Intensity on the Value of Alzheimer's Treatments. Clinical Trials on Alzheimer's Disease. Oct. 24-27, 2023. 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-- Company to Streamline Global Operations, Resulting in Approximately $70 Million of Cost Savings Over Next 12 Months and Accelerated Path to Positive Cash Flow -- -- Conference Call Today at 8:00 a.m. EDT with Investor Materials Available at AdvancingAmarin.com -- DUBLIN, Ireland and BRIDGEWATER, N.J., June 24, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation (NASDAQ: AMRN) today announced that the Company has entered into an exclusive long-term license and supply agreement (the “Agreement”) with Recordati S.p.A. (“Recordati”) to commercialize VAZKEPA® (icosapent ethyl) across 59 countries, focused in Europe. This Agreement capitalizes on the early-stage success of VAZKEPA in Europe by partnering with Recordati to accelerate the depth and reach of the product for patients at-risk of a cardiovascular event. As a result of the Agreement, Amarin will streamline its global operations, which further strengthens the Company’s financial position. Under the terms of the Agreement: Recordati will be responsible for commercialization of VAZKEPA in Europe.Amarin will receive: Upfront cash of $25 million and milestone payments totalling up to $150 million contingent upon Recordati achieving predefined annual commercial net sales levels;Supply-based revenues, including royalties for the supply of the product under the terms of the agreement Odysseas Kostas, M.D., Chairman of the Amarin Board of Directors, said, “Over the last couple of years, we have done a lot to thoughtfully redesign our operations and strategy in Europe, and we are proud of the efforts and accomplishments of the team in Europe. That said, partnering with Recordati, a market leader in Europe, is now the right decision for the company, financially and for patients.” Dr. Kostas continued, “We are pleased to place VAZKEPA, a drug with proven, meaningful cardiovascular benefit when added to statins, in the hands of a partner with the capabilities and experience in the cardiovascular space in Europe as Recordati. We believe this partnership for VAZKEPA positions both companies to benefit from future sales growth. Looking forward, Amarin will continue to pursue all options to further maximize long-term shareholder value.” “This long-term partnership with Recordati for VAZKEPA in Europe, where we have patent protection up to 2039, combined with the Company’s financial strengths – nearly $300 million in cash, no debt, an estimated $70 million in cost savings over the next 12 months and continued cost efficient revenue generation from multiple revenue streams – accelerates the path to positive cash flow and strengthens our strategic position for the future,” said Aaron Berg, President & CEO of Amarin. “We thank our team for their tremendous efforts to advance our global strategy and look forward to driving value for shareholders.” European Licensing Agreement with Recordati Recordati is an international pharmaceutical company, headquartered in Milan, Italy, with fully integrated operations across research & development, chemical and finished product manufacturing, commercialization and licensing. With a long heritage in cardiovascular disease, this category represents approximately 25% of Recordati’s Specialty and Primary Care business, and its cardiovascular portfolio addresses a range of diseases including hypertension, heart failure and other conditions. Recordati has a presence in more than 150 countries, including operations in European countries. “Recordati is a highly successful, well-established partner uniquely positioned to maximize the commercial opportunity for VAZKEPA in Europe. We are confident in Recordati’s ability to lead the next phase of growth and impact patient care with VAZKEPA throughout Europe,” Mr. Berg concluded. Rob Koremans, Chief Executive Officer, Recordati, commented, “We are extremely pleased with the agreement with Amarin for VAZKEPA® which underscores our deep expertise in the Cardiovascular space and our ongoing commitment to continue strengthening our Specialty & Primary Care business with innovative medicines in our core therapeutic areas. VAZKEPA® is a best-in-class treatment option that complements our existing portfolio, is supported by a robust clinical data package, has the ability to make a meaningful impact for cardiovascular patients and contribute to the growth of Specialty & Primary Care for years to come." Advancing Amarin’s Growth Strategy As a result of this Recordati partnership, Amarin is now better positioned to capitalize on the untapped global potential of VASCEPA/VAZKEPA while operating with increased efficiency to capture value from multiple revenue streams, further strengthening the Company’s financial position and accelerating its path to positive cash flow. Streamlining global operations to drive an estimated $70 million in cost savings over the next 12 months: Amarin will immediately initiate a global restructuring, with the vast majority of estimated cost savings from reduced commercialization expense from the Company’s Europe operations.Efficiently driving VASCEPA revenue in the U.S.: Amarin will continue maximizing its U.S. business, which is a mature, profitable enterprise with meaningful cash flows. The Company has multiple levers to continue to drive VASCEPA revenue and cash flow generation. Advancing access and penetration from Rest of World partnerships with minimal capital required: Amarin will continue to efficiently generate revenue through its partnerships in key international markets, many of which are in early commercialization stages, including Canada, MENA, China, Australia / New Zealand, and Southeast Asia, and will support these partners in their regulatory and commercial efforts to maximize the value of VASCEPA/VAZKEPA globally. The important actions announced today better position the Company to deliver shareholder value. Barclays has served as financial advisor on this transaction. The Board and management, with the assistance of Barclays, will continue to explore potential strategic actions to maximize value for shareholders. Wilke Farr & Gallagher LLP has served as legal counsel on the Agreement. Conference Call Information Amarin will host a conference call at 8:00 a.m. ET to discuss the announcement. The conference call can be accessed on the investor relations section of the Company's website at www.amarincorp.com, or via telephone by dialing 877-545-0523 within the United States, 973-528-0016 from outside the United States, and referencing conference ID 343003. A replay of the call will be made available for a period of two weeks following the conference call. To listen to a replay of the call, dial 877-481-4010 from within the United States and 919-882-2331 from outside of the United States, and reference conference ID 52649. A replay of the call will also be available through the Company's website shortly after the call. Supplemental Materials Investor materials, including a presentation, question and answer document and infographic, are available at AdvancingAmarin.com. 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 (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf 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 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. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s quarterly report on Form 10-Q for the period ending March 31, 2025 and annual report on Form 10-K for the fiscal year ended 2024. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Investors and others should note that Amarin communicates with its investors and the public using the company website (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 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 Investor & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.com Or Nick Lamplough, Tali EpsteinCollected StrategiesAmarin-CS@collectedstrategies.com