Alzheimer Disease, Familial, 1

A change in the initiation of donanemab dosing, shifting one vial of donanemab from the first infusion to the third infusion, lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen used in the pivotal Phase 3 clinical trialReduction of amyloid plaque and P-tau217 on this modified titration was comparable to patients receiving the standard dosing regimenLilly intends to submit this data to global regulators for a potential label update for Kisunla (donanemab-azbt) INDIANAPOLIS, Oct. 29, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer's disease (AD).1 Donanemab is approved under the brand name Kisunla™ in the United States, Japan, Great Britain and other countries. These data were presented at the 17th Clinical Trials on Alzheimer's Disease (CTAD) Conference in Madrid, Spain. Continue Reading Modified Titration Differs from Standard Dosing by Shifting a Single Vial. TRAILBLAZER-ALZ 6 is a multicenter, randomized, double-blind, Phase 3b study to investigate the impact of different dosing regimens of donanemab on the rates of ARIA-E and amyloid clearance in adults with early symptomatic AD, which includes mild cognitive impairment (MCI) and the mild dementia stage of disease. "Lilly is committed to continuing research to optimize therapy for patients with Alzheimer's disease. We are confident in the benefits of Kisunla's currently approved dosing regimen and are excited that these results reveal a path to potentially improving on Kisunla's profile by reducing the risk of ARIA-E," said Mark Mintun, M.D., group vice president Neuroscience Research & Development, Eli Lilly and Company, and president of Avid Radiopharmaceuticals. "The modified titration could offer continued convenience of once-monthly dosing and limited duration treatment while also reducing ARIA-E and maintaining similar amyloid plaque removal." The study included four treatment arms. One arm was the once-monthly standard dosing regimen used in the Phase 3 TRAILBLAZER-ALZ 2 trial. The other three arms used alternative dosing regimens with the same total drug administered. The results at 24 weeks showed the once-monthly modified titration described below met the predefined study success criteria and demonstrated the greatest reduction of ARIA-E compared to the other dosing arms.1 Patients on the standard dosing regimen received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafter. Patients on the modified titration received 1 vial (350 mg) for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion, and four vials (1400 mg) per infusion thereafter. The only difference between the modified titration and the standard dosing regimen is the shift of one vial from the first infusion to the third infusion. Pharmacokinetic (PK) analysis demonstrated equivalent cumulative exposure between modified titration and standard dosing regimen. The primary endpoint of the study was the proportion of participants with any occurrence of ARIA-E by week 24, and the results showed the incidence of ARIA-E was 14% in patients receiving the modified titration compared with 24% for those receiving the standard dosing regimen, a 41% lower relative risk. The largest ARIA-E reduction with the modified titration was seen in apolipoprotein E (APOE4) homozygotes, carriers of a known genetic risk factor for developing Alzheimer's disease. In these patients, 19% had ARIA-E on the modified titration as compared to 57% on the standard dosing regimen, resulting in a 67% lower relative risk. Patients on the modified titration of donanemab saw reduction of amyloid plaque and P-tau217 comparable to patients receiving the standard dosing regimen. As observed using amyloid PET at 24 weeks, amyloid plaque levels in patients on the modified titration of donanemab in TRAILBLAZER-ALZ 6 were reduced on average 67% from baseline compared to 69% for patients on the standard dosing regimen. The pathological relevance of beta-amyloid plaques in the development of Alzheimer's disease and the importance of removing plaques to slow disease progression has been well-established: both the Phase 3 TRAILBLAZER-ALZ 2 study and the Phase 2 TRAILBLAZER-ALZ study demonstrated that the removal of amyloid plaque from the brain can lead to statistically significant slowing of cognitive and functional decline in patients with early symptomatic Alzheimer's disease.2, 3 The TRAILBLAZER-ALZ 6 study is ongoing with data investigating the potential reduction of ARIA-E in adults with early symptomatic AD at week 52 expected early next year. Aside from the improvement in ARIA-E rates, safety profiles were comparable across arms, and no new safety signals were identified. The frequency of infusion-related reactions in the modified titration arm was similar to the standard dosing arm. One participant in the modified titration arm with an ongoing ARIA-E presented stroke-like symptoms, and after receiving tissue-type plasminogen activator treatment (tPA), subsequently died due to cerebral intraparenchymal hemorrhage. As noted in the FDA labeling for this class of medicines, caution should be exercised when considering the administration of agents such as thrombolytics (e.g. tPA) to patients already being treated with amyloid targeting therapies. Lilly is discussing the results of this study with global regulators, with the intent to submit for a potential label update for Kisunla. About TRAILBLAZER-ALZ 6 Study and the TRAILBLAZER-ALZ program TRAILBLAZER-ALZ 6 (NCT05738486) is a Phase 3b, multicenter, randomized, double-blind study to investigate different dosing regimens and their effect on ARIA-E in adults with early symptomatic Alzheimer's disease. The trial enrolled 843 participants ages 60-85 selected based on cognitive assessments in conjunction with amyloid plaque imaging by PET scan. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, focused on reducing risk of progression to symptomatic AD in participants with preclinical AD; and TRAILBLAZER-ALZ 5, a registration trial for early symptomatic AD currently enrolling in China, Korea, Taiwan, and other geographies. About Kisunla™ (donanemab) Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is an amyloid-targeting treatment for people with mild cognitive impairment (MCI) as well as people with mild dementia stage of early symptomatic Alzheimer's disease, with confirmed amyloid pathology. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions. Kisunla is a prescription medicine administered intravenously every four weeks, 700 mg for the first three doses and 1400 mg thereafter. INDICATION AND SAFETY SUMMARY WITH WARNINGS Kisunla™ (donanemab-azbt), pronounced 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. Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla. 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 © Lilly USA, LLC 2024. ALL RIGHTS RESERVED. 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 treatment for people with early symptomatic Alzheimer's disease, Kisunla dosing regimens and the prevalence of ARIA-E, and future readouts, presentations, 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 Eli Lilly. A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6). ClinicalTrials.gov identifier: NCT05738486. Updated July 24, 2024. Accessed September 30, 2024. . Kisunla (donanemab-azbt). Prescribing Information. Lilly USA, LLC. Data on File. Lilly USA, LLC. DOF-DN-US-0029. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

POTOMAC, Md.--( BUSINESS WIRE )--IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") announced today that the Company is advancing its proprietary formulation, IGC-AD1, toward clinical trials as a potential anti-amyloid disease-modifying treatment for Alzheimer's disease. Following the FDA's 2023 approval of two groundbreaking anti-amyloid drugs, Donanemab (Eli Lilly) and Lecanemab (Eisai and Biogen), IGC Pharma is poised to make a significant contribution to this critical field with IGC-AD1. The recognition of amyloid-targeted therapies in slowing Alzheimer's progression and improving cognitive function underscores the growing demand for innovative treatments. While the recent drug approvals have been a significant milestone in enhancing disease treatment, there is still an increasing demand for safe and effective treatments. IGC-AD1, an orally administered medication with a strong safety profile, potentially positions IGC Pharma favorably in this market landscape. IGC-AD1, with its patent protection, represents a promising advancement in Alzheimer's treatment. The APIs in IGC-AD1 have been shown to target amyloid plaques in Alzheimer's cell lines through two mechanisms: a) inhibiting amyloid protein production and b) preventing its aggregation. Preliminary data from Alzheimer's cell lines suggest that IGC-AD1 may reduce plaque aggregation by approximately 20% and decrease its production by up to 40% without affecting the production of Amyloid Precursor Protein ("APP"), which is essential for cell growth and survival. Ram Mukunda, CEO of IGC Pharma, stated, "As we continue our ongoing Phase 2 clinical trials for treating agitation in Alzheimer's dementia with IGC-AD1, we're excited to advance our research into its potential as an anti-amyloid disease-modifying treatment. Evidence from cell lines suggests that IGC-AD1 may reduce amyloid levels while preserving APP production, a critical factor for brain health. With Phase 1 and Phase 2 interim safety and tolerability data, IGC-AD1 stands out as a differentiated drug candidate. The initiation of disease-modifying investigational trials, expected in early 2025, will open a significant market opportunity for IGC Pharma. "By initiating new trials focused on IGC-AD1's ability to modify amyloid plaque progression, we hope to position IGC Pharma to deliver a breakthrough treatment in Alzheimer's disease, driving substantial value for our shareholders." About IGC Pharma (dba IGC): IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia associated with Alzheimer's ( clinicaltrials.gov , NCT05543681). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 28 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions. Forward-looking Statements This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Q filed with the SEC on August 7, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.

FOR GLOBAL MEDIA AND JOURNALISTS OUTSIDE THE EMEA REGION In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers1 Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD1 TOKYO and CAMBRIDGE, Mass., Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the humanized amyloid-beta (Aβ) monoclonal antibody "Leqembi®" (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.1 Lecanemab is indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers.1 Lecanemab becomes the first treatment for early AD (MCI and mild dementia due to AD)2 that targets an underlying cause of the disease, to be authorized in a country in Europe.1 Lecanemab selectively binds to Aβ aggregate species, with preferential activity for toxic Aβ protofibrils** (as well as fibrils, which are a major component of Aβ plaques).2,3,4 It binds to these aggregate Aβ species to neutralize and clear them from the brain.2,3,4 The approval was primarily based on Phase 3 data from Eisai's global, placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which the medicine met its primary endpoint (change from baseline in the Clinical Dementia Rating Sum of Boxes [CDR-SB]† at 18 months) and all key secondary endpoints with statistically significant results.2 In the indicated population in Great Britain, the most common adverse reactions were infusion-related reaction, amyloid-related imaging abnormalities with hemorrhage (small spots of bleeding) (ARIA-H)‡, fall, headache and amyloid-related imaging abnormalities with cerebral edema (build-up of fluid) (ARIA-E)‡‡.1 In the United Kingdom, it is estimated that 982,000 people are living with dementia,5 and AD is the cause in 60-70% of people with dementia.6 These numbers are expected to rise, as the population ages.5,6 Eisai is working collaboratively with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) to make this medicine available to eligible people living with early AD as soon as possible. Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In Great Britain, Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the Marketing Authorization holder. *Apolipoprotein E is a protein involved in the metabolism of fats in humans. It is implicated in AD. **Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.7 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.8 †CDR-SB is a commonly used diagnostic tool, which can help to stage dementia due to AD.9 It is a global cognitive and functional scale that measures six domains of functioning, including memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care.9 ‡ARIA-H: amyloid-related imaging abnormalities with hemorrhage (microhemorrhages, and superficial siderosis). ‡‡ARIA-E: amyloid-related imaging abnormalities with oedema (edema/effusion). More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval. Notes to Editors: 1. About lecanemab (Leqembi ® ) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).2,3 Lecanemab's approval in Great Britain was primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.1,2 Clarity AD was a Phase 3 global, placebo-controlled, double-blind, parallel-group, randomized study in 1,795 patients with early AD (MCI or mild dementia due to AD, with confirmed presence of amyloid pathology), of which 1,521 were in the indicated population in the label in Great Britain (ApoE ε4 heterozygotes or non-carriers).1 Of the total number of patients randomized 31% were non-carriers, 53% were heterozygotes and 16% were homozygotes.1 The treatment group was administered lecanemab 10 mg/kg bi-weekly, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab for 18 months.1 The primary endpoint was the global cognitive and functional scale, CDR-SB.1 In the Clarity AD clinical trial, treatment with lecanemab, in the indicated population in Great Britain (ApoE ε4 heterozygotes or non-carriers), reduced clinical decline on CDR-SB by 33% at 18 months compared to placebo.1 The mean CDR-SB score at baseline was approximately 3.2 in both groups.1 The adjusted least-squares mean change from baseline at 18 months was 1.15 with lecanemab and 1.73 with placebo (difference, −0.58; 95% confidence interval [CI], −0.81 to −0.34; P<0.00001).1 CDR-SB is a global cognitive and functional scale that measures six domains of functioning, including memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care.9 In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted 39% less decline compared to placebo at 18 months.1 The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.7 in the placebo group (difference, 2.2; 95% CI, 1.3 to 3.1; P<0.00001).1 The ADCS-MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. In the indicated population (ApoE ε4 heterozygotes or non-carriers), the most common adverse reactions were infusion-related reaction (26%), ARIA-H (13%), fall (11%), headache (11%) and ARIA-E (9%).1 Lecanemab is licensed in the U.S.,10 Japan,11 China,12 South Korea,13 Hong Kong,14 Israel,15 the United Arab Emirates16 and Great Britain1 and marketed in the U.S., Japan and China. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union. This medicine is subject to additional monitoring. This will allow quick identification of new safety information. 2. About NHS, NICE and SMC The NHS is a public healthcare system with the principle of providing free medical services to citizens. The NICE and the SMC are independent bodies that carry out assessments on the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products regarding their health benefits and price justification as advisory boards to the NHS about whether or not a newly licensed drug should be accepted for use under national health insurance. 3. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. 4. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody back-up was signed in May 2015. 5. About Eisai Co., Ltd. Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. For more information about Eisai, please visit (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit and Eisai EMEA LinkedIn. 6. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at . Follow Biogen on social media – Facebook, LinkedIn, X, YouTube. The website and social media channels are intended for audiences outside of the UK and Europe. Biogen Safe Harbor This news release contains forward-looking statements, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs; including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates; including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of the medicine; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. References 1 Lecanemab Great Britain Summary of Product Characteristics 2 van Dyck, H., et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023;388:9-21. . 3 Johannesson, M., et al. Lecanemab demonstrates highly selective binding to Aβ protofibrils isolated from Alzheimer's disease brains. Molecular and Cellular Neuroscience. 2024;130:103949. . 4 Sehlin, D., et al. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2):e32014. . 5 Alzheimer's Society. 2024. The economic impact of dementia. Available at: . Last accessed: August 2024. 6 World Health Organization. 2023. Dementia. Available at: . Last accessed: August 2024 7 Amin, L., Harris, D.A. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nature Communications. 2021;12:3451. doi:10.1038/s41467-021-23507-z. 8 Ono, K., Tsuji, M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. International Journal of Molecular Sciences. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. 9 Morris, J.C. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993;43:2412-2414. 10 U.S. Food and Drug Administration. 2023. FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval. Last accessed: August 2024. 11 Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen. Last accessed: August 2024. 12 The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi now approved in China. Last accessed: August 2024. 13 Pharmaceutical Technology. 2024. South Korea's MFDS approves Eisai-Biogen's LEQEMBI for Alzheimer's. Last accessed: August 2024. 14 Pharmaceutical Technology. 2024. Hong Kong approves Leqembi for Alzheimer's treatment. Last accessed: August 2024. 15 BioSpace. 2024. Leqembi approved for the treatment of Alzheimer's disease in Israel. Last accessed: August 2024. 16 United Arab Emirates Ministry of Health & Prevention. 2024. Registered Medical Product Directory. Leqembi. Last accessed: August 2024. SOURCE Eisai Co., Ltd.