Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that drug discovery research conducted on lemborexant (brand name: Dayvigo®), the dual orexin receptor antagonist discovered by Eisai, has been honored with The Pharmaceutical Society of Japan (PSJ) Award for Drug Research and Development 2024 by the PSJ.

The PSJ Award for Drug Research and Development is one of a series of awards presented by the PSJ and is dedicated to researchers who have conducted outstanding research work that has contributed to medicine through the innovative development of a pharmaceutical drug or applicable technology related to the pharmaceutical sciences. Award recipients are evaluated by the PSJ based on the ingenuity of the research itself as well as the effectiveness and safety of the related pharmaceutical product(s) or the innovativeness of the related medical treatment or treatment technology. Eisai was a four-time winner of the award for drug discovery research: in 1998 on donepezil hydrochloride, an Alzheimer’s disease treatment; in 2013 on eribulin mesylate, an anti-cancer agent; in 2020 on lenvatinib, a multikinase inhibitor; and in 2021 on perampanel, an AMPA-type glutamate receptor antagonist.

PSJ shared the following rationale for selecting lemborexant: “Unlike conventional drugs, based on the fact that the main cause of insomnia is the nocturnal hyperactivation of the wakefulness pathway, the compound targets inhibition of the wakefulness system, which is considered a rational therapeutic approach. The compound is highly original in its unique structure based on trisubstituted cyclopropanes, and has overcome many challenges in its optimization to a compound with a balanced profile by overcoming many pharmacokinetic and safety issues. In preclinical and clinical studies, it has demonstrated a superior efficacy and safety profile that sets it apart from conventional drugs, and the compound is meeting the unmet medical needs of many insomnia patients both in Japan and overseas.”

Lemborexant is currently approved for the indication of insomnia in over 15 countries, including Japan, the U.S., Canada, Australia, and countries in Asia.

Eisai considers neurology, including insomnia, a therapeutic area of focus. Eisai strives to create innovative products in therapeutic areas with high unmet medical needs as soon as possible, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with the disease and their families.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

HIGHEST RANKED GLOBAL PHARMACEUTICAL COMPANY

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been listed in the 2024 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc. This marks Eisai’s eighth inclusion on the list. Ranked 35th, Eisai is the highest ranking company among global pharmaceutical companies. Also, Eisai became the highest ranking Japanese company among the three Japanese companies listed in the Global 100 (please visit here for the Global 100 ranking).

The Global 100 evaluates the sustainability of more than 6,700 of the world’s major corporations based on various corporate initiatives in areas such as ESG (environment, society and governance). Since 2005, those companies ranking among the top 100 in the world have been announced each year. The Global 100 is based on up to 25 key performance indicators covering ESG initiatives, with the evaluations carried out based on data publicly disclosed in financial filings, integrated reports, or through other such channels. Eisai was highly evaluated, particularly in indicators for reducing greenhouse gas emissions, and enhancing employee value such as safe work environment, sick leave support system and employee retention rate.

Eisai’s corporate concept is to give first thought to patients and the people in the daily living domain, and increase the benefits that health care provides to them as well as meet their diversified healthcare needs worldwide. Based on this human health care (hhc) corporate concept, Eisai is striving to sustainably enhance corporate value by strengthening its ESG initiatives and increasing non-financial value.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

TOKYO and CAMBRIDGE, Mass., December 13, 2023 – 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 humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI^® Intravenous Infusion” (200mg, 500mg, lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) Drug Price List.

LEQEMBI received manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in Japan on September 25, 2023. In addition to inclusion in Japan’s NHI Drug Price List, the product’s Optimal Clinical Use Guidelines were agreed at a general meeting of the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Heath, Labour and Welfare, held today. The launch in Japan marks the second country to have LEQEMBI on the market, following the U.S.
In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.

LEQEMBI selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

“I am keenly aware of the weight of our responsibility moving forward as we launch LEQEMBI, the world first anti-amyloid Alzheimer’s disease treatment shown to slow the progress of the disease, in Japan, where Eisai’s value creation has started” said Haruo Naito, Chief Executive Officer at Eisai. “The establishment of an optimal and fast Alzheimer’s disease diagnosis and treatment pathway for patients is a top priority, and close collaboration among the government, dementia specialists, primary care physicians, radiologists, pharmacists, nurses, clinical psychologists, radiology staff, medical office personnel, and caregivers is essential for this purpose. In consideration of the importance of Alzheimer’s disease in Japan, we believe it is imperative that such pathways be established. We are committed to taking this first step towards changing the future of Alzheimer’s disease together with our stakeholders.”

“The availability of LEQEMBI opens a new era in the treatment of Alzheimer’s disease potentially giving patients and their families additional valuable time together and further positions Japan as a leader in caring for an elderly population,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen “We will work alongside Eisai to engage the medical community and support the patient journey, especially early diagnosis, as mounting evidence suggests early intervention may provide greater impact on disease progression.”

Eisai will conduct a post-marketing special use results survey in all patients who are administered LEQEMBI (all-case surveillance) until data from a certain number of patients are accumulated, in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. In addition, the appropriate use of LEQEMBI will be promoted in accordance with the package insert and the Optimal Clinical Use Guidelines, and training materials will be provided for healthcare professionals to assist with the management and monitoring of amyloid-related imaging abnormalities (ARIA).

Eisai and Biogen are committed to promoting the early detection and diagnosis of AD towards its early treatment, and will do their utmost to deliver LEQEMBI the people with early AD and realize a Dementia-Inclusive Society.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been named by the Japan Investor Relations Association (Chairman: Naoki Izumiya, “JIRA”) as one of the “Greatest IR Improvement Premium Company” and “Best Continual IR Efforts Premium Company” at the JIRA 30^th Anniversary Commemorative Awards.

The awards commemorate the 30th anniversary of JIRA, and are a special recognition of member companies that have continued IR activities over the medium to long term and have been recognized for their efforts to raise the level of appropriate information disclosure and constructive dialogue. Member companies have been selected for this recognition by the Judging Committee of the Best IR Awards based on the screening results for the past 17 years from 2007 to 2023. During this period, companies which have steadily been evaluated highly by committee members and have been recognized for their efforts to improve IR are selected as “Greatest IR Improvement Premium Company”, and companies which have continuously applied for the Best IR Awards and have been recognized for their continual IR efforts over the long term are selected as “Best Continual IR Efforts Premium Company”. 70 companies were selected each for “Greatest IR Improvement Premium Company” and “Best Continual IR Efforts Premium Company”.

Please visit the JIRA homepage for further details. https://www.jira.or.jp/english/

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, we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. This human health care (hhc) concept is also stipulated in our Articles of Incorporation, and to realize this concept, we have worked to quantify the value of non-financial capital, including social impact calculations and employee impact accounting to create long-term, sustainable corporate value, and have focused on communicating information on the link between financial and non-financial value, as well as the visualization of non-financial value, through dialogue between investors and top management and the publication of the Value Creation Report.

Eisai will continue to respect the rights of shareholders and investors, ensure fairness and transparency in management, and work on its IR activities to aid the enhancement of corporate value.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120