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TOKYO, Feb. 28, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today the company will present the latest findings on lecanemab (U.S. brand name: LEQEMBI®), Eisai's anti-amyloid beta (Aβ) protofibril* antibody for the treatment of Alzheimer's disease (AD), at the 2024 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD™) from March 5-9 in Lisbon, Portugal, and virtually. The lecanemab data and additional research findings from Eisai's AD portfolio will be featured in 18 presentations, including ten oral presentations. Eisai will present five oral presentations and one poster presentation on lecanemab results. From the Phase 3 Clarity AD study in subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed brain Aβ accumulation, presentations will include data on the effect of lecanemab treatment on tau accumulation in whole brain regions, and outcomes of long-term efficacy of lecanemab. In addition, the differences in the binding properties of multiple anti-amyloid (Aβ) antibodies to various types of Aβ and other data will be presented. Eisai will also host a symposium titled "Defining meaningful benefits to patients, caregivers, and healthcare systems in Alzheimer's disease". "Lecanemab treatment of early AD in the Phase 3 Clarity AD study had less clinical decline and slower tau accumulation than placebo," said Michael Irizarry, M.D., Deputy Chief Clinical Officer and Senior Vice President of Clinical Research at Eisai Inc. "The earlier MCI due to AD and mild AD dementia are diagnosed and treated, the greater the opportunity for the patient to benefit. We will continue to share the importance of and rationale for early treatment with lecanemab to the scientific community." Eisai Symposium – Defining meaningful benefits to patients, caregivers, and healthcare systems in Alzheimer's disease. Eisai is sponsoring a symposium featuring three prominent clinical experts in the field of AD, Dr. Jeffrey Cummings, Dr. Robert Perneczky and Dr. Miia Kivipelto. Dr. Jeffrey Cummings will chair the symposium, and provide an overview of meaningful benefits, including clinical meaningfulness and the evolution of approaches for the clinical study of AD. Dr. Robert Perneczky will discuss how to assess meaningful benefits of treatments in development for AD. Dr. Miia Kivipelto's presentation will provide new statistical methods to measure meaningful benefits and address various stakeholder perspectives. (Thursday, March 7, 11:10-12:50) Eisai's Chief Clinical Officer, Lynn Kramer, M.D., will give a plenary presentation as "Novel approaches to clinical development and the future potential of simulated placebo" on March 7 at the "Aβ TARGETING THERAPIES IN AD 1" session. AD/PD 2024 Presentations Relating to Eisai's Key Compounds and Research Oral Presentations Poster Presentations Eisai-Sponsored Symposium Plenary Presentation Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. * Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.1, 2,3 [Notes to editors] 1. About Lecanemab Lecanemab (brand name in the U.S.: LEQEMBI®) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer's disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted traditional approval on July 6, 2023. In the U.S., treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. Please see full Prescribing Information. In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023, to manufacture and market lecanemab as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD. In China, Eisai received approval for the treatment of MCI due to AD and mild AD in January 2024 LEQEMBI's approval was based on Phase 3 data from Eisai's large, global Clarity AD clinical trial, in which LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of LEQEMBI.4,5 The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. 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 a statistically significant benefit of 37% compared to placebo. The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the LEQEMBI group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. Eisai has also submitted applications for approval of lecanemab in 11 countries and regions, including EU, Canada and Great Britain. Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing of lecanemab is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE). A maintenance dosing regimen has been evaluated as part of Study 201. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 2. 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 LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. 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 LEQEMBI for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody LEQEMBI back-up was signed in May 2015. References 1 2 Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2):e32014 Epub 2012 Feb 15. PMID: 22355408; PMCID: PMC3280222. 3 Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab — Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer's Disease. Neurotherapeutics (2022). . Accessed February 9, 2023. 4 Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer's disease at Clinical Trials on Alzheimer's Disease (CTAD) conference. Available at: Last accessed: February 2024. 5 van Dyck. C, et al. Lecanemab in Early Alzheimer's Disease. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2212948. SOURCE Eisai Inc.

SAN JUAN, Puerto Rico, Feb. 12, 2024 /PRNewswire/ -- Attorneys for Milberg Coleman Bryson Phillips Grossman ("Milberg"), Napoli Shkolnik, and Kresch Legal Services PR have filed an amended proposed class action complaint on behalf of Puerto Rico residents who claim they were injured by ethylene oxide (EtO) emissions from sterilization facilities located in the Commonwealth. Ethylene oxide is a colorless gas emitted by plants that use it to sterilize medical equipment and produce chemicals. Known to cause cancer, EtO is one of the most toxic air pollutants regulated by the Environmental Protection Agency (EPA). More than 14 million people in the U.S.—most of them residents of low-income, non-English speaking communities of color—live within five miles of a facility that emits ethylene oxide. Emissions are alarmingly prevalent in Puerto Rico, where there are seven sterilizer plants, including four of the most dangerous facilities, according to a report from the Union of Concerned Scientists. The report found that roughly 13% of Puerto Rico's neighborhoods are impacted by the release of EtO from medical facilities. "Hundreds of thousands of Puerto Ricans have, unknowingly, been breathing air poisoned by the defendants," said Environmental Attorney Wendy Kerner of Kresch Legal Services. "These corporations have chosen to use ethylene oxide at their facilities when feasible alternatives were available, causing unimaginable, yet preventable, suffering across the island." The lawsuit alleges that sterilization companies Customed, Inc., Medtronic PR, Inc., Edwards Lifesciences Technology Sarl, and Steri-Tech, Inc. have emitted large quantities of EtO into the air for decades in Puerto Rico, despite evidence of its human harms and without warning residents. The plaintiffs, suffering from ailments that include spina bifida, fibromyalgia, thyroid issues, asthma, and cancer, are seeking injury compensation as well as medical monitoring costs for Puerto Ricans affected by EtO exposure. "Corporations like the defendants often concentrate their environmental harms in communities that are the least able to fight back against them," said Milberg Senior Partner Marc Grossman. "Puerto Rico is the poorest U.S. jurisdiction, and people of color make up 99% of the population within five miles of the defendants' sterilizers." The carcinogenic and DNA-damaging effects of EtO have been widely studied and known since the 1940s and definitively known to the defendants since at least 1984, the lawsuit states. However, the defendants chose to operate their facilities and emit the dangerous gas in the densely populated areas of Añasco, Fajardo, Salinas, and Villalba. "Of particular concern in this case is the health of children and community members who may appear healthy today, but due to years of inhaling EtO emitted by the defendants are far more likely to develop potentially fatal injuries in the years to come," said Napoli Shkolnik Associate Nevin Wisnoski. "We seek what the common law has always been intended to provide through damages—compensation and deterrence. Medical monitoring for these impacted communities is a critical aspect of reaching that aim." The suit has been filed in the Federal District Court of Puerto Rico, Case Number 3:23-cv-1445. More updates will be provided as the case develops. About Milberg Coleman Bryson Phillips Grossman: For over 50 years, Milberg and its affiliates have defending the rights of victims of corporate wrongdoing and have recovered over $50 billion for clients. A pioneer in class action litigation, the firm has been recognized as leaders in the plaintiffs' bar and appointed to numerous leadership roles in prominent national mass torts and class actions. About Napoli Shkolnik: Napoli Shkolnik is an international litigation firm providing representation to persons in class action lawsuits and complex commercial cases, as well as victims of environmental contamination disasters, aviation accidents, defective prescriptions drugs and medical devices, asbestos-related illnesses, and other serious personal injury matters. About Kresch Legal Services PR: 1-800-LAW-FIRM is a team of seasoned lawyers who strongly believe in holding accountable companies that put profits over people. The firm joins forces with the nation's best law firms to pursue litigation related to personal injuries, consumer protection, environmental hazards, civil rights violations, and other matters. Media Contact: Karine Lim [email protected] SOURCE Milberg Coleman Bryson Phillips Grossman PLLC

Lecanemab treats MCI due to Alzheimer’s disease and mild AD dementia. Credit: CGN089 / Shutterstock.com. BioArctic AB and its partner Eisai have announced the approval of the amyloid beta-directed antibody Leqembi (lecanemab-irmb) in China to treat mild cognitive impairment (MCI) associated with Alzheimer’s disease (AD) and mild AD dementia. China is the third country to approve the drug for marketing, after the US and Japan. In July and September 2023, the US and Japanese regulatory authorities respectively approved the drug. Leqembi, developed in partnership with BioArctic, will be made available in the region in the third quarter of 2024. Eisai will be responsible for distribution and information provision works through expert medical representatives. The approval in China is based on results from the international Phase III Clarity AD study. Leqembi met its primary and key secondary endpoints with statistically significant outcomes. Leqembi treatment also reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB), a cognitive and functional scale, by 27% at 18 months compared with placebo. Infusion reactions, combined cerebral microhaemorrhages and superficial siderosis were the most frequently seen adverse events linked to Leqembi. The drug is the first and only approved therapy demonstrated to decelerate the disease progression rate, as well as the cognitive and functional decline. Eisai now manages the clinical development, regulatory work and marketing of the treatment. BioArctic is eligible to receive payments for specific regulatory approvals, sales-based milestones and royalties on global product sales. The company also retains the right to market lecanemab in the Nordic region, subject to European approval. Eisai has now sought approval for lecanemab in 11 countries and regions, including the European Union, Canada and Great Britain. The companies entered a long-term partnership to develop and market drugs for Alzheimer’s treatment in 2005 and, in 2007, made a deal for lecanemab.