Author: Durian

TOKYO, Nov 15, 2024 - (JCN Newswire via SeaPRwire.com) - Mitsubishi Shipbuilding Co., Ltd., a Mitsubishi Heavy Industries (MHI) Group company, today held a christening and launch ceremony for the TRANS HARMONY EMERALD, the second of two LNG-powered roll-on/roll-off (RO/RO) ships(Note) under construction for Toyofuji Shipping Co., Ltd. The ceremony took place at the Enoura Plant of MHI's Shimonoseki Shipyard & Machinery Works in Yamaguchi Prefecture. The ship's handover is scheduled for June 2025 following completion of outfitting work and sea trials. The TRANS HARMONY EMERALD will serve as a RO/RO vessel on shipping routes in Asia.Christening and Launch Ceremony of TRANS HARMONY EMERALDThe TRANS HARMONY EMERALD is approximately 195 meters in overall length, approximately 30.6 meters in breadth, and has gross tonnage of approximately 49,500. It can simultaneously transport about 3,000 passenger cars. The ship's main engine and main generator engine are high-performance dual-fuel engines each accommodating LNG or diesel fuel. Together these engines enable a greater than 25% reduction in CO2 emissions compared to ships with the same hull and powered by fuel oil, cutting SOx (sulfur oxides) emissions to near zero, thereby helping to reduce the vessel's environmental footprint.The christening and launch ceremony of the first vessel, "TRANS HARMONY GREEN," for Toyofuji Shipping, has already been held this June, and its handover is scheduled for late January 2025.Mitsubishi Shipbuilding, as part of MHI Group's strategic initiatives for energy transition, today contributes toward realizing a carbon-neutral world by building LNG-powered ships enabling the maritime industry to achieve a low-carbon footprint. Going forward, as a maritime system integrator the Company will continue to work with its business partners to solve diverse issues through construction of ferries and RO/RO ships that will contribute to stable operations at sea while also providing outstanding energy and environmental performance.RO/RO ships are equipped with a ferry-type ramp enabling direct vehicle access, including cargo-loaded trucks and trailers.About 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, Nov 15, 2024 - (JCN Newswire via SeaPRwire.com) - Eisai Co., Ltd. and Biogen Japan Ltd announced today that a TV commercial will be broadcast nationwide in Japan from November 15 with the aim of increasing public understanding of MCI (Mild Cognitive Impairment).MCI refers to the stage between "normal brain function" and "dementia," where the individual can still lead an independent daily life but cognitive functions of the brain, such as memory and judgment, have somewhat declined. If cognitive function further declines from the MCI stage to a state where it disrupts daily life and care becomes necessary, it is then diagnosed as dementia.In 2022, there were 5.58 million people living with MCI in Japan, accounting for 15.5% of those aged 65 and over, and estimated to reach 6.12 million by 2040. 1 While MCI is often referred to as a precursor to dementia, it doesn’t necessarily progress to dementia. Depending on the cause, the condition may be maintained, or even improved. If you are concerned about forgetfulness, early consultation with a specialist is important for the early detection of MCI and clarification of its cause, through which appropriate measures can be taken to prevent the progression from MCI to dementia. This TV commercial tells the story of a mother whose daughter worries for her, always telling her "You just said that earlier". The mother realizes that the forgetfulness she attributed to old age might in fact be due to MCI, leading her to seek medical advice.A survey2 conducted by Eisai showed that awareness of the term "MCI" was 12%, while understanding of it was only 2%, which is still low. Through this TV commercial, Eisai and Biogen Japan hope to increase awareness of MCI among a broader range of people, thereby raising public interest in cognitive impairment and contributing to the early detection and treatment of MCI.(1) Research on the Prevalence and Future Projections of Dementia and Mild Cognitive Impairment, 2023 Elderly Health Promotion Project Grant, Professor Toshiharu Ninomiya, Kyushu University(2) Internet surveyTarget: Japan nationwide, men and women aged 60-70, 2000 responsesSurvey period: February 2024Survey conducted by: Macromill Carenet, Inc. About the TV CommercialTitle: MCI Disease Awareness TV Commercial "Don't Miss it, MCI" Edition (15 seconds/30 seconds)TV Broadcast Start: November 15, 2024Broadcasting Area: Japan nationwideMain CM Video: Published on YouTube from November 15(https://youtube.com/@patients_eisai?si=vLaA-y07QAlORHLa)About EisaiEisai'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, Oncology and Global Health.Theoria technologies Co., Ltd., a member of the Eisai Group, operates the dementia portal site "Theotol" (https://theotol.soudan-e65.com/), which provides easy-to-understand contents and services for the general public about MCI and various types of dementia, their causes, treatments, as well as caregiving methods and personal experiences. (Japanese only)About Biogen JapanFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ 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.We routinely post information on Biogen Japan that may be important to investors on our website at https://www.biogen.com/ and social media X, LinkedIn, Facebook, YouTubeMEDIA CONTACTSEisai Co., Ltd.Public Relations DepartmentTEL：+81 (0)3-3817-5120Biogen Japan, Ltd.Corporate AffairsTEL：＋81-70-1501-4315E-mail: Japan-PA@biogen.com Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO, Nov 15, 2024 - (JCN Newswire via SeaPRwire.com) - Eisai Co., Ltd. and Biogen Inc. announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis ofmild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.1 Eisai had requested a re- examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process,the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.2Lecanemab selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain.3,4,5AD currently affects an estimated 6.9 million people in Europe,6 and this figure is expected to nearly double by 2050 as agingpopulations increase.7 AD progresses in stages that increase in severity over time, and each stage of the disease presentsdifferent challenges for those living with AD and their care partners. There is a significant unmet need for new treatment options that slow down the progression of early AD and reduce the overall burden on people affected by AD and society.Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision- making authority.* Apolipoprotein E is a protein involved in the metabolism of fats in humans. It is implicated in AD.** Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline of this progressive, debilitating condition.8 Protofibrils cause injury to neurons in the brain which, in turn,can negatively impact cognitive function via multiple mechanisms,8 not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may slow the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.9About lecanemab (generic name, brand name: 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).Lecanemab’s Positive Opinion from the CHMP in the European Union was primarily based on Phase 3 data from Eisai’sglobal Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.1,3 Clarity AD was a Phase 3 global, placebo-controlled, double-blind, parallel-group, randomized study in1,795 patients with early AD (MCI or mild dementia due to AD, with confirmed presence of amyloid pathology), of which 1,521 were in the recommended indicated population (ApoE ε4 non-carriers or heterozygotes ). 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 recommended indicated population (ApoE ε4 non- carriers or heterozygotes), reduced clinical decline onCDR-SB by 31% at 18 months compared to placebo based on conservative control based imputation.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 18months was 1.217 with lecanemab and 1.752 with placebo (difference, −0.535; 95% confidence interval [CI], −0.778 to−0.293; 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.10In 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 33% less decline compared to placebo at 18 months.1 The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADLscore was −3.873 in the lecanemab group and −5.809 in the placebo group (difference, 1.936; 95% CI, 1.029 to 2.844; P=0.00002).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 ApoE ε4 heterozygotes or non-carriers population, the most common adverse reactions were infusion-related reaction (26%), ARIA-H (13%), headache (11%) and ARIA-E (9%).1Lecanemab has been approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates and Great Britain and is under regulatory review in 17 countries. A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024, which was accepted in June 2024. In May 2024, the rolling submission of a Biologics License Application (BLA) for maintenancedosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the U.S. under Fast Track status, with the rolling submission and completed in October 2024.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 ofMedicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.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. 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.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 ADtreatments. 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 lecanemab 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 thebenefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim toeffectively 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 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 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 ofhuman 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.Biogen Safe HarborThis news release contains forward-looking statements, including 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 insuch 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 delayapproval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions madeby the regulatory authorities regarding lecanemab; uncertainty of success in the development and potentialcommercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietaryrights 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 considerthis cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in otherreports 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) Committee for Medicinal Products for Human Use. 2024. Leqembi (Lecanemab). Overview. Last accessed: November 2024(2) European Medicines Agency. The Centralised Procedure at the EMA. Available at: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines. Last accessed: November 2024.(3) 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.(4) AlzForum. 2021. Lecanemab Sweeps Up Toxic Aβ Protofibrils, Catches Eyes of Trialists. Available at: https://www.alzforum.org/news/conference-coverage/lecanemab-sweeps-toxic-av-protofibrils- catches-eyes-trialists. Last accessed: February 2024.(5) 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.https://doi.org/10.1371/journal.pone.0032014 Epub 2012 Feb 15. PMID: 22355408; PMCID: PMC3280222.(6) Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer's disease continuum. Alzheimer’s & Dementia. 2023;19:658-670. https://alz- journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12694.(7) Alzheimer Europe. Prevalence of dementia in Europe. Available at: https://www.alzheimer-europe.org/dementia/prevalence-dementia-europe.(8) Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z(9) Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.(10) Morris, J.C. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993;43:2412-2414.MEDIA CONTACTSEisai Co., Ltd.Public Relations Department TEL: +81 (0)3-3817-5120Eisai Europe, Ltd.EMEA Communications Department+44 (0) 797 487 9419Emea-comms@eisai.netBiogen Inc.Jack Cox+ 1-781-464-3260public.affairs@biogen.comEisai Inc. (U.S.)Libby Holman+1-201-753-1945Libby_Holman@Eisai.comINVESTOR CONTACTSEisai Co., Ltd.Investor Relations Department TEL: +81 (0) 3-3817-5122Biogen Inc.Stephen Amato+ 1-781-464-2442IR@biogen.com Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO, Nov 15, 2024 - (JCN Newswire via SeaPRwire.com) - Resorttrust Group and Mitsubishi Corporation ("MC") have agreed to conduct a joint study of opportunities in the medical tourism sector. Under this agreement, MC and Resorttrust Group company Advanced medical care Inc.("AMC") will evaluate the establishment of a joint venture company to facilitate medical tourism to Japan and globally promote the country's advanced medical screening technologies and healthcare services.Rapid population growth and economic development in Asia have raised awareness of lifestyle-related diseases and preventive healthcare, which has in turn driven up demand for high-precision medical screenings and treatments. Resorttrust Group and MC aim to capitalizing on this growing demand by promoting medical tourism to Japan, which is renowned for its abundant medical facilities, advanced screening technologies, and high-quality healthcare services. Our objectives are to help extend worldwide healthy life expectancy and create new economic value by leveraging both the growth of Japan's healthcare-related industries and the revitalization of its local economies.In addition to providing administrative support for its Group's medical facilities, Resorttrust's know-how extends to healthcare technologies and services, as well as hotel and other tourism operations. MC brings to the table a global network of business partners, digital-transformation (DX) capabilities, and solutions for healthcare providers. This new joint venture will combine our companies' respective expertise to accomplish the following aims:1. Strengthen overseas marketing of Japanese medical services2. Develop inbound patient referral schemes for domestic medical institutions3. Take advantage of medical-facility DX to accelerate the establishment of inbound patient acceptance systemsMC and Resorttrust Group are confident that success in these initiatives will encourage global applications of Japan's medical services. Looking further to the future, our goal is to develop businesses that are invested in the mental and physical well-being of people all over the world, including wellness-tourism services that deliver Japanese health culture and traditional culture experiences.As part of this joint study, we will conduct the following verification activities at several facilities, including Nihonbashi Muromachi Mitsui Tower Midtown Clinic and Tokyo Tower Midtown Clinic, which are operated by AMC:- Market research in Asian countries for the global expansion of Japanese medical screening technologies and healthcare services- Analysis of current challenges and enhancement measures related to inbound patient referral processes- Effectiveness evaluation of AI-powered multilingual communication tools specialized for medical services, developed in collaboration with the MC Group companies, Industry One, Inc. and MC Digital, Inc.About Resorttrust, Inc.Resorttrust Group's core business includes membership-based resort hotels and hotel restaurant operations. In 1994, the group expanded into the medical /healthcare sector by launching a membership-based comprehensive medical club. Today, the group has broadened its healthcare solutions beyond medical screenings into treatment services. The group's subsidiary, Cancer Intelligence Care Systems, Inc., is developing an accelerator-based neutron irradiation system for Boron Neutron Capture Therapy, aiming to provide cancer treatments with reduced patient burden. Additionally, Resorttrust Group provides operational support to facilities offering advanced cancer immunotherapy and stem cell treatments for conditions such as arteriosclerosis, joint pain, and frailty prevention and improvement. https://www.resorttrust.co.jp/About Advanced Medical Care Inc.Consulting for medical and health screening business, support for medical facility management, education and training of medical personnel and assistants, sales of cosmetics and supplements. https://www.amcare.co.jp/About Mitsubishi CorporationMC develops diversified businesses in a wide range of industries through its eight groups: Environmental Energy, Materials Solution, Mineral Resources, Urban Development & Infrastructure, Mobility, Food Industry, S.L.C. (Smart-Life Creation), and Power Solution. https://www.mitsubishicorp.com/ Copyright 2024 JCN Newswire via SeaPRwire.com.