TOKYO and CAMBRIDGE, Mass., Aug 22, 2024 - (JCN Newswire via SeaPRwire.com) - Eisai Co., Ltd. and Biogen Inc.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 treatmentof mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein Eε4 (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.1Lecanemab 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.2,3,4The 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 Inthe 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)‡‡.1In 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.5,6Eisai 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.MEDIA CONTACTSEisai Co., Ltd.Public Relations Department TEL: +81 (0)3-3817-5120Eisai Europe, Ltd.EMEA Communications Department+44 (0) 7974-879-419Emea-comms@eisai.netBiogen Inc.Jack Cox+ 1-781-464-3260public.affairs@biogen.comEisai Inc. (U.S.)Libby Holman1-201-753-1945Libby_Holman@eisai.comINVESTOR CONTACTSEisai Co., Ltd.Investor Relations Department TEL: +81 (0) 3-3817-5122Biogen Inc.Chuck Triano+ 1-781-464-2442IR@biogen.comAbout lecanemab (Leqembi®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).2,3Lecanemab’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 3global, placebo-controlled, double-blind, parallel-group, randomized study in 1,795 patients with early AD (MCI or milddementia due to AD, with confirmedpresence of amyloid pathology), of which 1,521 were in the indicated population in the label in Great Britain (ApoE ε4heterozygotes 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.1The 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.9In 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-ADLscore 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 ofpatients 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%).1Lecanemab 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.About NHS, NICE and SMCThe 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.About the Collaboration between Eisai and Biogen for ADEisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisaiserves 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.About the Collaboration between Eisai and BioArctic for ADSince 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 theantibody back-up was signed in May 2015.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 www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us onX, 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 www.eisai.eu and Eisai EMEA LinkedIn.About BiogenFounded 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 www.biogen.com.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 HarborThis 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; thetreatment 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 numberof research and development programs result in commercialization of a product. Results in early-stage clinical studies may notbe 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; regulatoryauthorities 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 uncertaintiesrelating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results ofoperationsand financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ fromBiogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the riskfactors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securitiesand Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake anyobligation to publicly update any forward-looking statements.(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. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.(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. https://doi.org/10.1016/j.mcn.2024.103949.(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. https://doi.org/10.1371/journal.pone.0032014.(5) Alzheimer’s Society. 2024. The economic impact of dementia. Available at: https://www.alzheimers.org.uk/about-us/policy-and-influencing/dementia-scale-impact-numbers. Last accessed: August 2024.(6) World Health Organization. 2023. Dementia. Available at: https://www.who.int/news-room/fact- sheets/detail/dementia. Last accessed: August 2024(7) Amin, L., Harris, D.A. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxicoligomers. 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. Copyright 2024 JCN Newswire via SeaPRwire.com.

Toyota City, Japan, Aug 22, 2024 - (JCN Newswire via SeaPRwire.com) - TOYOTA GAZOO Racing (TGR) began accepting orders today for the new GR Supra GT4 EVO2, for which vast feedback from racing teams and drivers around the world was leveraged to achieve higher levels of performance, reliability, and operability.Since the launch of the GR Supra GT4 in 2020, thanks to the support of race organizers and customers, cumulative sales(1) of the model have surpassed 120 units. The efforts of racing teams and drivers have enabled it to win GT4-series races and international races in 11 countries and regions, earn more than 500 podium finishes(2), and become the class champion in three regions: Asia, the United States, and Europe.An updated GR Supra GT4 EVO for the 2023 season featured improved braking, handling, and engine performance, making the car easier to drive for drivers of various skill levels. Yet, after that update, with there being no end to its efforts to make ever-better motorsports-bred cars, TGR continued to travel to race tracks around the world to directly receive valuable feedback from racing teams and drivers that can only be obtained under the extreme conditions of racing. Advancing its "driver-first car-making" approach for leveraging such insights into development, TGR has set the race debut of the GR Supra GT4 EVO2, with improved performance, reliability, and operability, at the start of the 2025 season.Specifically, ABS maps were meticulously re-tuned through driving by various drivers on circuits in Japan and Europe to enable optimal braking and cornering based on tire type and wear and the condition of the course. Additionally, downshifting time has been reduced by fine-tuning the rev matching through a software update, leading to enhanced deceleration control during braking for increased cornering speed. Also, in addition to improving the cooling performance of the engine, brakes, and drivetrain, cockpit temperatures have been optimized to make the car easier to drive even in harsh conditions, helping to maintain a high level of performance. These improvements make the GR Supra GT4 EVO2 easier to drive not only for professional racers but also for amateur drivers ambitiously competing in GT4 races worldwide.The GR Supra GT4 EVO2 is scheduled to make its world debut in January 2025 in the first round of the IMSA Michelin Pilot Challenge, held in conjunction with the 24 Hours of Daytona.GT4 sales and customer support (spare parts sales and technical support) will be handled by TOYOTA GAZOO Racing Europe GmbH in Europe, TRD U.S.A., Inc. in North America, Toyota Customizing and Development Co., Ltd. in Japan and other countries in Asia (excluding China), and Toyota Motor (China) Investment Co., Ltd. in China.(1) Including the GR Supra GT4 EVO(2) As of the end of July 2024For more information, visit https://global.toyota/en/newsroom/toyota/41393991.html. Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO, Aug 22, 2024 - (JCN Newswire via SeaPRwire.com) - Mitsubishi Heavy Industries, Ltd. (MHI), together with Kirin Group companies Kirin Beverage Co., Ltd. and Kirin Group Logistics Co., Ltd., in August will begin a joint demonstration aimed at establishing elemental technologies for the automation of inbound and outbound processes at beverage warehouses, and the loading and unloading of trucks. The joint demonstration will be conducted at LogiQ X Lab, a demonstration facility located within Yokohama Hardtech Hub (YHH), MHI's co-creation space in Honmoku, Yokohama, and at Kirin Group Logistics sites. The demonstration is scheduled to conclude by March 2026.For this demonstration, as part of the "Smart Connections" solutions incorporating the ΣSynX (Sigma Syncs) technology(Note1) that MHI is currently researching and developing, MHI will utilize a new type of unmanned forklift that is currently under development equipped with ΣSynX, with the aim of establishing elemental technologies that enable flexible autonomous operation and safe human-machine coordination, including appropriate load assortment in warehouse work, altering of operational routes in response to changes in placement locations and storage conditions, and highly efficient storage methods. Through this joint demonstration, MHI aims for future automation of the entire cargo handling process, from the unloading of trucks to handling of inbound and outbound warehouses process, and loading onto trucks.MHI is steadily advancing efforts to utilize "Smart Connections" solutions incorporating the ΣSynX (Sigma Syncs) technology for automation and intelligence of normal logistics warehouse work, which up to now has been conducted safely and efficiently through the expertise, experience and skills of operators, focusing on the three areas of picking, inbound and outbound processes, and the loading and unloading of trucks. Following picking, which is the handling of cargo in warehouses, MHI will pursue development and verification to support the implementation of "Smart Connections" solutions for warehouse operations in the logistics industry. MHI and Kirin Group conducted a joint demonstration of automated picking from November 2022 to June 2023.(Note2) This demonstration verified its effectiveness at logistics sites, and an automated picking solution is scheduled to start operation at Kirin Group's Ebina Logistics Center in Kanagawa Prefecture from December 2024. This new joint demonstration being conducted by the two companies will accelerate the response to the challenges posed to the logistic industry by regulatory changes implemented in 2024.Going forward, through coordination with Kirin Group for this demonstration program, MHI will work to provide solutions for the various issues faced by the beverage industry due to regulatory changes, such as the shortage of logistics operators, the need for improvement in working conditions, and reducing truck driver working hours and wait times.(1) ΣSynX (Sigma Syncs) is MHI's standard platform for synchronizing and coordinating various types of machinery systems. It consolidates a host of digital technologies that enable optimized operation by making machinery systems intelligent. For more information, please refer to the following press release. www.mhi.com/news/23100501.html(2) For more information on the joint demonstration with Kirin Group for an automated picking solution, please refer to the following press release. www.mhi.com/news/22112101.html　Overview of the Joint DemonstrationImplementation period: August 2024, through March 2026Demonstration sites: MHI's LogiQ X Lab demonstration facility at Yokohama Hardtech Hub (YHH), MHI's demonstration facility at Kobe Shipyard, and Kirin Group Logistics facilities such as Nishi-Nagoya and Amagasaki.Content for the demonstration- Determining of operational processes, including manned work, assuming the introduction of warehouse inbound and outbound process solutions- Determining of operational processes, including manned work, assuming the introduction of unmanned forklifts for loading and unloading trucks- Determining of safety concepts, rules, operating conditions, and other standards for collaborative work with manned and unmanned forkliftsTags: Sigma SynX,Smart InfrastructureAbout MHI GroupMitsubishi Heavy Industries (MHI) Group is one of the world’s leading industrial groups, spanning energy, smart infrastructure, industrial machinery, aerospace and defense. MHI Group combines cutting-edge technology with deep experience to deliver innovative, integrated solutions that help to realize a carbon neutral world, improve the quality of life and ensure a safer world. For more information, please visit www.mhi.com or follow our insights and stories on spectra.mhi.com. Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO, Aug 22, 2024 - (JCN Newswire via SeaPRwire.com) - Techstars Tokyo Accelerator powered by JETRO and Mitsui Fudosan is proud to announce the 12 startups selected for the Class of 2024. These promising, early-stage companies are addressing challenges in categories such as Women’s Health, Gaming, Animation, Productivity Enhancement, B2B Business Intelligence, Robotics and more.Taking place in the rapidly growing tech ecosystem of Tokyo, the three-month mentorship-driven program is bringing together founders from across the globe from countries of Finland, India, Indonesia, U.S. and Vietnam along with six Japanese companies. The 2024 class was chosen for innovative products and solutions in areas that will revolutionize how entertainment industries work, how the companies manage their data, and how people live and work better.“We are thrilled to welcome the very first class of Techstars Tokyo Accelerator program,” said Yuki Shirato, Managing Director at Techstars. “This exceptionally talented and diverse group of founders demonstrates tremendous potential and we’re eager to offer our full support leveraging our network of mentors, investors and talents locally and globally and growth-focused tools and workshops, to propel them towards success.”Demo Day is scheduled on November 12th, 2024, where founders will have an opportunity to pitch their businesses to a community of mentors and potential investors.Introducing our inaugural class for the Techstars Tokyo Accelerator!- Aman (Jakarta, Indonesia)Supercharges customized employee health benefits for micro, small and medium enterprises- Amatama (Nagoya, Japan)Optimizes hierarchical computational technology development for humanoids to completely replace labor- Assethub (California, US)Provides an easy way to create unique 3D models from pictures using AI- Digital Will Inc. (Tokyo, Japan)Democratizes gaming with our AI-enhanced platform, WORTAL, for game developers- Dondon Technologies, Inc. (New Jersey, US)Accelerates 2D anime production with AI-assisted drawing tools- InfraHive (Rajasthan, India)Develops data intelligence for finance, analytics and customer teams of enterprises- March Health (California, US)Revolutionizes women’s health (endometriosis) with an AI-first clinic in your pocket- Pioneerwork (Tokyo, Japan)Automates and expedites dropshipping for retail e-commerce- Samaria Inc. (Tokyo, Japan)Unleashes the potential of Japanese manga to the world with AI- Saner.AI (Ho Chi Minh, Vietnam)Revolutionizes knowledge management for knowledge workers, particularly people with ADHD- StoryDrops (Helsinki, Finland)Builds a platform of authenticity through creating and sharing audio messages- Undesk (Tokyo, Japan)Provides a multi-player browser to improve team communication and productivityAbout TechstarsTechstars is the most active pre-seed investor in the world having invested through its accelerators in more than 3,800 companies. Founded in 2006, Techstars believes that entrepreneurs create a better future for everyone and great ideas can come from anywhere. Now we are on a mission to invest in an unprecedented number of startups per year enabling more capital to flow to more entrepreneurs around the world. We do this by operating accelerator programs and venture capital funds, as well as by connecting startups, investors, corporations, and cities to help build thriving startup communities. www.techstars.comMedia Contact for TechstarsAmalia Lytleamalia.lytle@techstars.com Copyright 2024 JCN Newswire via SeaPRwire.com.