Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been included in the FTSE4Good Index Series for the 22^nd?consecutive year since its initial inclusion in 2002. The FTSE4Good Index Series is a global index series for socially responsible investment.

The FTSE4Good Index Series was developed by FTSE Russell to promote investment in companies that meet global environmental, social and governance (ESG) standards. Eisai received particularly high scores in “Corporate Governance”, “Anti-Corruption”, “Tax Transparency”, “Labor Standards” and “Customer Responsibility”, among others. As of the end of June 2023, 1,121 companies worldwide and 250 Japanese companies were included in the FTSE4Good Developed Index Series.

Currently, in addition to the MSCI ESG Leaders Indexes, another global ESG investment index, Eisai is also listed in the FTSE Blossom Japan Index, the FTSE Blossom Japan Sector Relative Index, the MSCI Japan ESG Select Leaders Index, the MSCI Japan Empowering Women Index (WIN) and the S&P/JPX Carbon Efficient Index, which are ESG investment indices for Japanese stocks adopted by the Government Pension Investment Fund (GPIF).

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 to them, as well as address diverse healthcare needs worldwide. By strengthening its ESG initiatives and increasing non-financial value, Eisai is striving to sustainably enhance corporate value based on this concept.

For more information on our ESG initiatives, please visit https://www.eisai.com/sustainability/index.html.

Also, we post and share ESG-related information on Twitter, LinkedIn and Facebook.

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

The first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease

The Centers for Medicare & Medicaid Services (CMS) announced broader Medicare coverage of LEQEMBI

TOKYO and CAMBRIDGE, Mass., July 6, 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 the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI? (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (MCI) due to AD or mild AD. Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.

LEQEMBI’s traditional approval is 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. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). LEQEMBI treatment reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. Additionally, the secondary endpoint of AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), as measured by people caring for patients with AD, noted a statistically significant benefit of 37%. This measures the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. Full results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) 2022 conference and simultaneously published in the peer-reviewed medical journal The New England Journal of Medicine on November 29, 2022.

Importantly, following FDA’s traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available and released more details on the registry, including the easy-to-use data submission process. The CMS-facilitated registry is now available for healthcare professionals to submit required patient data to CMS. Eisai is pleased that Medicare will cover this important therapy for appropriate patients. This will facilitate reimbursement for and access to LEQEMBI across a broad range of healthcare settings in the United States.

“Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease. As a research and development-focused company based on our hhc (human health care) concept, we are proud that the results of Eisai’s AD research over the past 40 years have been recognized and delivered to people living with this disease in the United States,” said Haruo Naito, Chief Executive Officer at Eisai. “Alzheimer’s disease is a progressive, fatal disease that greatly impacts not only the people living with it, but also their loved ones, care partners and society. We continue to work to create broad and simple access to LEQEMBI for patients and to support diagnosis and treatment at the early stage of the disease. Eisai will diligently work to educate physicians on the safe and appropriate use of LEQEMBI to maximize its benefit to people living with early AD and their families.”

“Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable. We would like to express our sincere appreciation to those who have worked tirelessly to find a treatment for this unrelenting disease, without whom this progress would not be possible,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “Our focus is now on the path forward, working alongside Eisai with the goal of making LEQEMBI accessible to eligible patients as soon as possible.”

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta (Aβ). Critically, LEQEMBI targets and clears the most neurotoxic form of Aβ that continuously accumulates as well as removes the existing plaques to treat this progressive, chronic disease. In June 2023, the FDA’s Peripheral and Central Nervous System Drugs (PCNS) advisory committee voted unanimously that the data from Eisai’s Clarity AD clinical trial confirmed the clinical benefit of LEQEMBI for the treatment of AD. Committee members also confirmed the overall risk-benefit of LEQEMBI. On January 6, 2023, LEQEMBI was approved by the FDA under the accelerated approval pathway.

Eisai has developed and deployed Understanding ARIA?, a multi-faceted educational initiative to further advance understanding in the AD healthcare community of the real-world management and monitoring of amyloid-related imaging abnormalities (ARIA). In collaboration with experts in the field of medical imaging as well as major professional societies, Understanding ARIA? offers resources and programs that include peer-to-peer education, individual and group educational sessions and subject matter-expert evaluation of historical case studies.

Eisai is committed to ensuring that appropriate patients have access to LEQEMBI and has established a Patient Assistance Program to provide LEQEMBI at no cost, for eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other program criteria. Additionally, Eisai offers patient support for improving access through LEQEMBI Patient Navigators, who will provide information about accessing LEQEMBI, help patients and their families understand their insurance coverage and options, and identify financial support programs for eligible patients. People in the U.S. can learn more about these services by visiting LEQEMBI.com, calling 1-833-4- LEQEMBI (1-833-453-7362), Monday-Friday, 8 a.m. to 8 p.m. Eastern Time or faxing an enrollment form to 1-833-770-7017.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

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

Biogen Inc.
Jack Cox
+ 1 781-464-3260
[email protected]

Eisai Inc. (U.S.)
Libby Holman
+ 1-201-753-1945
[email protected]

Eisai Europe, Ltd.
(UK, Europe, Australia, New Zealand and Russia)
EMEA Communications Department
+44 (0) 786 601 1272
[email protected]

Investor Contacts:
Eisai Co., Ltd.
Investor Relations Department
TEL: +81 (0) 3-3817-5122

Biogen Inc.
Chuck Triano
+ 1-781-464-2442
[email protected]

On June 26^th, Tencent Healthcare and Eisai China signed a strategic cooperation agreement. The two parties will use Tencent Healthcare’s pharmaceutical industry SaaS solution – NGES (Next Generation Engagement Suite), a one-stop management platform for physician interaction as a base, by deeply integrating Tencent’s connectivity advantages and digital technology with Eisai China’s core scenarios of customer management, multi-channel marketing and conference event management, Eisai China will realize a new paradigm of online and offline integration of academic communication, in order to help Eisai China open up the whole domain scenarios, link up “application islands”, continue to cultivate the Chinese market with management upgrade and model innovation, and achieve high-quality development.

Yanhui Feng, Senior Vice President of Eisai Global and President of Eisai China, Alexander Ng, Vice President and Head of Tencent Healthcare, Yang Zhou, General Manager of NTA BU of Eisai China, and Yu Zhang, Vice President of Tencent Healthcare, attended the strategic cooperation signing ceremony on behalf of both parties.

From left: Yang Zhou, Yanhui Feng, Alexander Ng and Yu Zhang

With the gradual improvement, the development of digitalization in the pharmaceutical industry is moving towards more intelligence and refinement. The application of various digital technologies will play an increasingly important role in reducing costs and increasing efficiency for pharmaceutical companies. As a branch of a multinational pharmaceutical R&D company in China, the introduction of Tencent Healthcare’s intelligent pharmaceutical NGES platform is a comprehensive upgrade of the cooperation between Eisai China and Tencent’s online conference scenarios. Through a one-stop access to the whole scenario of academic communication with professional doctors, Eisai China will realize accurate academic education with information collaboration and data interconnection to help market development and patient accessibility for innovative products in various fields such as neurology, oncology and GI related diseases.

NGES is Tencent Health’s first SaaS solution for the pharmaceutical industry. With WeChat as the carrier, it takes the three scenarios, CRM (one-stop healthcare professionals visit), Events (online and offline meeting management) and MCM (multi-channel marketing), refines the whole process of doctors-interaction. And based on WeChat and other digital intelligence tools, it helps pharmaceutical companies deeply engage doctors in terms of one-stop access to doctors-interaction scenarios, reaching users while conducting two-way interaction and providing intelligent behavioral suggestions, making academic communication more convenient, smooth and efficient.

Yanhui Feng states: “Eisai China has always adhered to the hhc (human health care) corporate philosophy and practiced the hhceco (hhc ecosystem) development model. The deepening cooperation with Tencent Health is an important part of the 4New Strategies of ‘new products, new channels, new platforms and new business’ in China. Both parties will give full play to their leading advantages in the field of cutting-edge therapies and digital technology, jointly explore innovation model for the future-oriented specialized academic communication, establish efficient information transfer and sustainable business cycle, and continuously consolidate the infrastructure construction of enterprise information development.”

Alexander Ng states, “The pharmaceutical industry has witnessed an accelerated pace of digital transformation amid the evolving landscape. Through NGES-based one-stop interactive platform, we hope to support Eisai China to reshape its model to engage healthcare professionals. With the online extension of academic-based multi-channel communication, Eisai China will become a more agile organization with a holistic business approach.”

In addition to the NGES academicized communication platform, Tencent Healthcare formed a full map of digital capabilities to help transforming the pharmaceutical industry by enabling faster, more efficient, and more effective drug development and healthcare service and cloud security base. By embracing these digital technologies, pharmaceutical companies will continue to drive innovation and improve patient outcomes.

Peripheral and Central Nervous System Drugs Advisory Committee voted based on data from large global confirmatory Phase 3 Clarity AD clinical trial in patients living with early Alzheimer’s disease

The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023, with designation of priority review

LEQEMBI received accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 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 the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI? (lecanemab-irmb) 100 mg/mL injection for intravenous use for the treatment of Alzheimer’s disease (AD). Additionally, the committee members confirmed the overall benefit-risk profile of LEQEMBI, the clinical meaningfulness of the data and discussed its use in specific subgroups, including Apolipoprotein E (ApoE) ε4 homozygote patients, patients requiring concomitant treatment with anticoagulant agents, and patients with cerebral amyloid angiopathy.

The unanimous decision by the panel of independent experts was based on the supplementary Biologics License Application (sBLA) which includes data from Eisai’s large global confirmatory Phase 3 Clarity AD trial. The Clarity AD trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline (27%, p=0.00005) compared to placebo over 18 months. Highly statistically significant treatment effects were also observed for all multiplicity-controlled secondary endpoints that examined cognition and functional changes using other validated scales. The most common adverse events (>10%) in the LEQEMBI group were infusion reactions (LEQEMBI: 26.4%; placebo: 7.4%), ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis: LEQEMBI: 17.3%; placebo: 9.0%), ARIA-E (edema/effusion: LEQEMBI: 12.6%; placebo: 1.7%), headache (LEQEMBI: 11.1%; placebo: 8.1%), and fall (LEQEMBl: 10.4%; placebo: 9.6%). Infusion reactions were largely mild-to-moderate (grade 1-2: 96%) and occurred on the first dose (75%). The results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peerreviewed medical journal, The New England Journal of Medicine.

LEQEMBI, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta (Aβ), received accelerated approval on January 6, 2023, and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD. Its continued approval may be contingent upon verification of LEQEMBI’s clinical benefit in the confirmatory Clarity AD trial (Study 301). The advisory committee agreed unanimously that Study 301 verified the clinical benefit. The Prescription Drug User Fee Act (PDUFA) action date for the traditional approval is July 6, 2023.

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.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO^?), will be given at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3 to 7, 2023 in Indianapolis, IN, the United States.

Major poster presentations include new data about the effects of lemborexant on obstructive sleep apnea (poster numbers: #298, 299 and 300).

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