The Scrip Awards, now in its 19th year, celebrates the best innovations and achievements of the international biopharma industry.

The award for Best New Drug recognizes excellence in pharmaceutical development and celebrates LEQEMBI as the first and only treatment approved in Japan and the United States shown to reduce the rate of disease progression and to slow cognitive and functional decline, which acts on the underlying pathology of AD.

The award for Clinical Advance of the Year recognizes the success of a new drug product in a clinical trial that is expected to lead to an advance in healthcare. It was awarded for the success of the Phase III Clarity AD study of LEQEMBI.

Eisai and Biogen deeply appreciate the cooperation of people living with AD and healthcare professionals who participated in LEQEMBI’s clinical studies.

AD is a progressive, fatal disease, and a global healthcare issue that greatly impacts not only the people living with the disease, but also their loved ones, care partners and society. Eisai and Biogen will deliver LEQEMBI to the people with early AD who need it, as well as aim to continue creating impact on global issues surrounding dementia.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product. Eisai has the final decision-making authority.

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

TIME’s annual list of THE BEST INVENTIONS features “200 extraordinary innovations changing lives.” To compile the list, TIME solicited nominations from its editors and correspondents around the world, and through an open online application process, paying special attention to growing fields, such as AI, green energy, and sustainability. TIME then evaluated each contender on a number of key factors, including originality, efficacy, ambition, and impact. (For more information, please visit http://www.time.com/best-inventions-2023)

LEQEMBI is the first and only treatment approved in Japan and the United States shown to reduce the rate of disease progression and to slow cognitive and functional decline, that acts on the underlying pathology of AD.

AD is a progressive, fatal disease, and a global healthcare issue that greatly impacts not only the people living with the disease, but also their loved ones, care partners and society. Based on our corporate concept of “human health care (hhc),” we have taken on the challenge of this difficult issue through our nearly 40 years of drug discovery activities in the field of dementia, while spending time with patients and their families. We will deliver LEQEMBI to the people with early AD who need it and their families, and aim to continue creating impact on global issues surrounding dementia.

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

Please see full Prescribing Information, including Boxed WARNING in the United States.

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

Eisai Co. Ltd (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will present new data from the phase 3 Clarity AD study for its Alzheimer’s disease (AD) treatment LEQEMBI^? (lecanemab-irmb) 100 mg/mL injection for intravenous use and new data on the subcutaneous formulation in development at the 16th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference. The conference will be held in Boston, Massachusetts, United States and virtually from October 24 to 27, 2023. In addition to the data presented on Eisai’s anti-amyloid beta (Aβ) protofibril* antibody LEQEMBI, phase 1 data for E2511, an investigational tropomyosin receptor Kinase A (TrkA) positive allosteric modulator (PAM), will be presented as well as other research from the company’s AD pipeline. At the conference, Eisai will present data and research in five oral and ten poster presentations. BioArctic will give an oral presentation on lecanemab.

Late-Breaking Symposium 4 – Lecanemab for early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers, and Novel Subcutaneous Administration

• In a late-breaking symposium on October 25 from 17:25-18:05 EDT, Eisai will present the latest data from the Clarity AD optional tau PET longitudinal substudy. The presentation will include a post-hoc analysis of the low and intermediate + high-tau subgroups, with the low-tau subgroup representing early stages of disease studied specifically in the phase 3 core study, and the open-label extension study. An update on the investigational subcutaneous formulation, including interim safety and effect on amyloid in the brain measured by amyloid PET, will be provided.
• Distinguished faculty members Christopher van Dyck M.D., Keith Johnson M.D. and Reisa Sperling M.D. will discuss the findings in a panel led by Michael Irizarry, M.D., MPH, Eisai.
• A live webcast of this symposium can be viewed on the?Eisai Co., Ltd. website.

“Alzheimer’s disease is a progressive and relentless condition that requires early diagnosis and continued treatment. LEQEMBI supports neuronal function in Alzheimer’s disease by clearing highly toxic protofibrils that can continue to cause neuronal injury and death well after plaques are cleared,” said Michael Irizarry, MD, MPH, Senior Vice President, Clinical Research, Neurology, Deputy Chief Clinical Officer, Clinical Evidence Generation, Eisai. “We look forward to sharing the new LEQEMBI low-tau subgroup data and subcutaneous data at CTAD 2023.”

Other major oral presentations include:

• Lecanemab: Binding profiles of lecanemab and donanemab to different amyloid-beta species (OC19, presentation by BioArctic).
• E2511, a novel TrkA modulator, engages its CNS cholinergic target in a phase 1 clinical study (OC34).
• Novel CSF tau biomarkers can be used for disease staging of sporadic Alzheimer’s disease (OC2).

The full list of presentations about Eisai assets and research follows.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

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

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]

Notable presentations include a post-hoc analysis of tumor response by baseline characteristics of the metastases from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib (LENVIMA^?), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA^?), anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (NCT02811861; Presentation: #1903P). An exploratory analysis from the pivotal Phase 3 Study 309/KEYNOTE-775 trial of outcomes for patients with advanced endometrial cancer who completed treatment with pembrolizumab and continued with lenvatinib will also be presented (NCT03517449; Presentation: #748P).

“As a research and development-focused company driven by our hhc (human health care) concept, we strive to make a difference in the lives of patients and their families by advancing the science of cancer medicine with our robust portfolio and pipeline,” said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. “At this year’s ESMO meeting, analyses from the pivotal Phase 3 CLEAR and Study 309/KEYNOTE-775 trials may provide greater insights into the treatment of patients with advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. We also look forward to sharing data for lenvatinib and from our pipeline, as well as engaging in critical scientific exchange with the community in service of moving oncology research forward.”

Additional data from the LEAP (LEnvatinib And Pembrolizumab) clinical program to be presented include safety-run-in results from the Phase 3 LEAP-014 trial evaluating lenvatinib plus pembrolizumab and chemotherapy as a treatment option for patients with metastatic esophageal squamous cell carcinoma (NCT04949256; Presentation: #1534P). A network meta-analysis of lenvatinib versus key comparators as first-line treatment for patients with unresectable hepatocellular carcinoma will also be presented during a poster session (Presentation: #1007P).

Research from Eisai’s pipeline will be featured in a poster presentation of findings from the dose-expansion portion of a Phase 1 study evaluating E7389-LF, a liposomal formulation of eribulin, as a potential first-line chemotherapy treatment option for patients with metastatic/advanced HER2-negative breast cancer (Presentation: #405P). Additionally, insights from preclinical research on farletuzumab ecteribulin (FZEC, formerly known as MORAb-202), a folate receptor alpha (FRα)-targeting antibody drug conjugate (ADC), in endometrial cancer will be presented (Presentation: #786P).

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of presentations is included below. These abstracts will be made available via the ESMO website on Monday, October 16, 2023, at 12:05 AM CEST.

In?March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside?the United States?and?Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the pembrolizumab, anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, NJ, USA.??Eisai and Merck & Co., Inc., Kenilworth, NJ, USA are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across multiple clinical trials.

In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of FZEC. Eisai and Bristol Myers Squibb are currently investigating FZEC in multiple studies including: a Phase 1/2 clinical study for select solid tumors including endometrial cancer, a Phase 2 clinical study for non-small cell lung cancer, and a Phase 2 clinical study for ovarian cancer, peritoneal cancer and fallopian tube cancer.

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

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of Aβ. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates (protofibrils) that contribute to neurotoxicity in AD. In Japan, an application for marketing approval was filed and was designated for priority review in January 2023. Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.

LEQEMBI’s 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). 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. 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.

“Today LEQEMBI received approval, making it the first 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 in Japan. We believe that we have turned a new page in the history of Alzheimer’s disease treatment. Alzheimer’s disease is a progressive and serious disease that not only causes significant impairment and burden for the people living with it and their care partners, but also has a tremendous impact on society as a whole,” said Haruo Naito, Chief Executive Officer at Eisai. “For around 40 years since we began research on dementia at our Tsukuba Research Laboratories, Eisai has interacted with people with dementia and their care partners, and made efforts to understand their sincere feelings. In response, we have been taking on the challenge to develop therapeutic agents that act on the underlying pathology of Alzheimer’s disease. We are committed to delivering LEQEMBI to the people with early Alzheimer’s disease who need it and their families as a new treatment that removes the cause of the disease. Through these efforts, we aim to create impact on issues surrounding dementia in Japanese society.”

“With this approval, alongside Eisai, we will be able to help address the devastating impact Alzheimer’s has on people living with the condition as well the emotional, social and financial burden it places on care partners,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “This is a significant step in the work of Biogen and Eisai to usher in a new era of treatments for this disease which impacts millions. We look forward to working alongside Eisai to build on the approvals in the U.S. and now Japan to bring this option to patients and their families worldwide.”

Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered LEQEMBI until data from a certain number of patients are accumulated after market launch, 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 training materials will be developed for healthcare professionals to assist the management and monitoring of amyloid-related imaging abnormalities (ARIA).

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. In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.

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

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

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

With the aim of relieving the anxieties of people with dementia and their families and addressing social issues, Eisai is not only creating therapeutic drugs, but also working to build a dementia ecosystem through the development of digital solutions and collaboration with other industries. Theoria technologies will serve as the core of a highly transparent and neutral dementia platform, and the foundation for the development of an ecosystem to empower the people with dementia, regardless of the type or stage of the disease, to “l(fā)ive their fullest lives”.

Theoria technologies will accelerate decision-making and strengthen the hiring and training of digital talent under an organizational structure optimized for digital business, and will utilize clinical study data that Eisai has accumulated over many years as well as cohort study data, Personal Health Records (PHR), and other data to develop various prediction algorithms, create digital solutions and provide data. Theoria technologies will commence business activities in April 2024, with the aim of providing services for a risk prediction algorithm for early detection of mild cognitive impairment (MCI) and dementia in FY2024. In addition, together with Eisai, Theoria technologies will develop and provide Sasaeru, an application that helps facilitate communication between people with dementia, doctors, and caregivers by recording Activities of Daily Living (ADL) of the people with dementia. Furthermore, Theoria technologies will promote the development of digital services by strengthening collaboration with other companies.

Eisai is aiming to create social impact by realizing a Dementia Inclusive Society where people with dementia and the people in the daily living domain can live their lives how they would like, through the development of an ecosystem.

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

Joint Statement:

Today, the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labour and Welfare (MHLW) has recommended that lecanemab’s manufacturing and marketing authorization application for the treatment of early Alzheimer’s disease should be approved, which is a major step forward in the treatment of Alzheimer’s disease in Japan. We would like to express our deepest gratitude to all patients, caregivers, and healthcare professionals who participated in the lecanemab clinical trials. Once approved, we will do our best to appropriately deliver lecanemab, which was the first to demonstrate a clear reduction in the rate of Alzheimer’s disease progression and slowing of cognitive and functional decline, as a new treatment option for patients suffering from early Alzheimer’s disease in Japan.

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

“At AAIC 2023 Eisai will present the latest data on lecanemab, an anti-Aβ protofibril antibody, that recently received traditional approval in the U.S. for patients with mild cognitive impairment (MCI) due to AD and mild AD. Leqembi was studied in a broad population, which included a mix of racial and ethnic groups and patients with common comorbid conditions and concomitant medications.” Additionally, Eisai will present important new data on E2814, an anti-MTBR tau antibody, which is currently in Phase II/III clinical trials with the Dominantly Inherited Alzheimer’s Network Trials Unit at Washington University St. Louis,” said Michael Irizarry, M.D., Deputy Chief Clinical Officer and Senior Vice President of Clinical Research, Alzheimer’s Disease and Brain Health, Eisai Inc. “As part of Eisai’s commitment to transparency and our human health care (hhc) and ecosystem mission, we will continue to present and publish data and information about our AD pipeline and research.”

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.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

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

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]