EISAI TO PRESENT NEW DATA FROM LEQEMBI® (LECANEMAB-IRMB) PHASE 3 CLARITY AD STUDY AND OTHER ALZHEIMER’S DISEASE PIPELINE RESEARCH AT THE CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE

by codm | Oct 16, 2023 | Newsletter

Update on LEQEMBI Investigational Subcutaneous Formulation

For Print (PDF)

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^1,2,3 and continued treatment. LEQEMBI supports neuronal function in Alzheimer’s disease^1,4,5 by clearing highly toxic protofibrils^3,4 that can continue to cause neuronal injury and death well after plaques are cleared,”^5,6,7,8 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.

■ Late Breaking Symposium 4
The Symposium title: Lecanemab for Early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration from 17:25 to 18:05 EDT on October 25, 2023.

■ Oral Presentations

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.

*Protofibrils

• One of the AD pathological features is the accumulation of clusters (plaques) of amyloid beta (Aβ) in the brain. The formation of these plaques is the result of a continuous process by which individual Aβ proteins join together, latching onto each other, one at a time, like adding links to a chain.⁹ In the early part of this process these small chains of Aβ are soluble and are toxic to the nerves within the brain.^10,11 

• The most toxic of the soluble chains is called a protofibril^.3 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 associated with this progressive, debilitating condition.^1,2
• Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, 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 prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.¹²

Investor Contacts:

EISAI TO PRESENT RESEARCH FROM ONCOLOGY PORTFOLIO AND PIPELINE AT ESMO CONGRESS 2023

by codm | Oct 11, 2023 | Newsletter

For Print (PDF)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2023, which is taking place virtually and in-person in Madrid, Spain from October 20 to 24.

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

[Notes to editors]
1. Eisai’s Focus on Cancer
Eisai acknowledges “Oncology” as one of its key strategic areas, and will continue to focus on the discovery and development of anti-cancer drugs within drug discovery domains including “tumor microenvironment”, “proteostasis disruption”, “cell linage and cell differentiation”, and “inflammation, hypoxia, oxidative stress and cell senescence” under the Deep Human Biology Learning (DHBL) drug discovery and development organization. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains with the aim of contributing to the cure of cancers.

* KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Notice of Absorption-Type Merger (Simplified Merger/Short-Form Merger) of KAN Research Institute, Inc.

by codm | Oct 4, 2023 | Newsletter

For Print (PDF)

Company Name: Eisai Co., Ltd.
Representative: Haruo Naito,

Representative Corporate Officer and CEO
(Code No. 4523 Tokyo Stock Exchange Prime Market)
Inquiries: Sayoko Sasaki, Vice President
Corporate Communications
(Phone +81-3-3817-5120)

Eisai Co., Ltd. (Head Office: Tokyo; Representative Corporate Officer and CEO: Haruo Naito; the “Company” or “Eisai”) hereby announces that the Company has today decided to absorb and merge with KAN Research Institute, Inc., the Company’s wholly owned subsidiary (Address: Hyogo Prefecture; “KAN Research Institute”) on April 1, 2024 (the “Merger”). Since the Merger is a simplified absorption-type merger targeting the Company’s wholly owned subsidiary, certain disclosure items and details have been omitted.

1. Purpose of the Merger
In October 2022, the Company group’s research and development (R&D) organization transitioned to the Deep Human Biology Learning (DHBL) drug discovery and development. Under the DHBL drug discovery and development, Eisai views disease as a continuum and is redefining the disease concept through comprehensive analysis of the genomic, pathophysiological and clinical information associated with the root cause of the disease. Thereafter, Eisai will deepen its knowledge of human biology by acquiring data such as biomarker and imaging data, obtained from patients who have taken the Company’s drugs, which will lead to next-generation drug discovery, and thereby aim to create innovative next-generation drug discovery concepts.

KAN Research Institute was established in 1997, as a separate corporation that can independently operate in order to promote drug discovery activities by taking an approach that is different from that of the Company. KAN Research Institute has succeeded in its own technology development concerning the acquisition of antibodies, drug delivery to the brain, generation of genetically modified animal models, etc.

Meanwhile, under the DHBL drug discovery and development, the Company has been promoting the integrated management of facilities and costs, and effective deployment of human resources in Eisai group’s R&D related organizations and, in order to fully utilize the human resources, technology, facilities, etc., of KAN Research Institute, the Company decided to absorb and merge with KAN Research Institute. Through this merger, Eisai will further deepen it’s understanding of human biology, while KAN Research Institute will continue to contribute to the innovative creation as a major base of drug discovery research of the Company.

2. Summary of the Merger
(1) Schedule of the Merger

(Note) The Merger constitutes a simplified merger pursuant to Article 796, Paragraph (2) of the Companies Act on the part of the Company and a short-form merger pursuant to Article 784, Paragraph (1) of the Companies Act on the part of KAN Research Institute. Therefore, the Merger is conducted without obtaining the approval of either company’s general shareholders meeting regarding the Merger Agreement.

(2) Method of the Merger
The Merger is an absorption-type merger with the Company as the surviving company and KAN Research Institute as the absorbed company which dissolves as a result of the Merger.

(3) Details of allocation related to the Merger
Since the Company holds all shares in KAN Research Institute, no consideration will be provided upon the Merger.

(4) Treatment of share options and bonds with share options associated with the Merger
Not applicable.

3. Overview of the companies involved in the Merger (as of March 31, 2023)

(Note) The shareholding ratios are calculated after deducting the treasury shares from the total number of issued shares.

TOKIO MARINE NICHIDO AND EISAI CO-DEVELP INDUSTRY’S FIRST “DEMENTIA CARE SUPPORT INSURANCE”

by codm | Sep 28, 2023 | Newsletter

For Print (PDF)

Tokio Marine & Nichido Fire Insurance Co., Ltd.

Eisai Co., Ltd.

 1.  Background
Tokio Marine Nichido and Eisai concluded a business alliance agreement for the realization of a Dementia Inclusive Society in August 2019, and the two companies have promoted initiatives to achieve this purpose, including the provision since April 2021 of “NouKNOW^®※1”, a digital tool for self-assessment of cognitive function developed by Eisai, as an ancillary service for “Long-term care indemnity (installment payment)”, sold by Tokio Marine Nichido.

Dementia was thought to be difficult to treat, but with the approval of a new drug for Alzheimer’s disease, which accounts for 60% of dementia cases, and the hope of slowing disease progression by starting treatment in the early stages of disease, the preparation for early detection and early treatment is becoming increasingly important.

Amid such circumstances, the two companies co-developed a new insurance product, “Dementia Care Support Insurance” to financially support early detection and early treatment of the disease, with the expertise Tokio Marine Nichido has developed through dealing with insurance products and related services and Eisai’s extensive experience in the field of dementia.

^※1 A tool for checking brain reaction speed, attention, visual learning and memory through four types of simple tests with images of playing cards on a PC, tablet, or smartphone. (Not a medical device)

2.  Overview of (Industry’s First^※2) “Dementia Care Support Insurance”

(1)   Details of Coverage/Service
The new treatment is indicated for patients with mild cognitive impairment and mild cognitive impairment due to Alzheimer’s disease, but determination of eligibility requires medical tests, including a PET scan, to confirm amyloid-β pathology. Since these tests and treatments require a certain level of out-of-pocket expenses, the following coverage will be provided for financial support.

①  Lump-sum benefit for mild cognitive impairment (Support for early detection)
In the event of the first diagnosis of mild cognitive impairment (including dementia), a lump sum benefit for the purpose of covering costs for amyloid PET tests, etc. is provided.
②  Lump-sum benefit for mild cognitive impairment due to Alzheimer’s disease (Support for early stage treatment)
In the event of the first diagnosis of mild cognitive impairment due to Alzheimer’s disease (including dementia due to Alzheimer’s), a lump-sum benefit for the purpose of covering medical costs for treatment with the new drug is provided.

Additionally, the policy provides the opportunity to use “NouKNOW” as an ancillary service, ensuring the support of early detection and early treatment by identifying cognitive decline.

^※2 The first coverage in the non-life insurance industry focusing on mild cognitive impairment due to Alzheimer’s disease and dementia due to Alzheimer’s disease (according to a survey conducted by Tokio Marine Nichido)
^※3 May vary depending on terms of contract

(2)   Process Upon Signing The Policy
Potential policy holders need to complete a “NouKNOW” test to purchase the policy, along with completing a Statement of Health form.

(3)   Insurance Premium
Monthly 1,370 yen (in the case of a male aged 50 to 54 years receiving a 300,000 yen lump-sum benefit for mild cognitive impairment, and 1 million yen for mild cognitive impairment due to Alzheimer’s disease). *May vary depending on terms of contract

(4)   Type of Policy
A group insurance in which a large-scale entity, such as a company, purchases the policy and its members voluntarily purchase the coverage through the entity.

3.  Future Perspectives
Tokio Marine Nichido and Eisai will further promote efforts to resolve various social challenges by expanding our network through collaboration with various companies and organizations, to realize a Dementia Inclusive Society.

Media Contacts:

EISAI LAUNCHES NEW “INNOVATION” PAGE ON CORPORATE WEBSITE

by codm | Sep 28, 2023 | Newsletter

For Print (PDF)

Eisai Co., Ltd. (Head office: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has launched a new “Innovation” page on its corporate website. The “Innovation” page is comprised of four sections: “Research & Development (R&D),” “Ecosystem,” “Open Innovation,” and “Corporate Venture Capital,” which are the core of Eisai’s innovation creation. Each part introduces information such as Eisai’s strengths, originality, and the status of specific initiatives.

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 our human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities.

On the newly established “Innovation” page, Eisai has enhanced information on policies, characteristics, and examples of initiatives for innovation creation aimed at realizing it’s corporate concept. The “R&D” section contains new contents, such as an overview of the Deep Human Biology Learning (DHBL) drug discovery and development system, which was established last year, track records of Eisai’s long-term commitment to dementia, oncology and tropical diseases, and the current status of digital technology application in R&D settings. In addition, the “Ecosystem” section explains Eisai’s policy of evolving into an hhceco (hhc concept + ecosystem) company to empower people to “realize their fullest lives” how they would like, from the time that they are in good health up to their final moments, and the dementia hhceco model on which Eisai is focusing. Moreover, the “Open Innovation” and “Corporate Venture Capital” sections introduce their respective business policies and achievements, and an inquiry page for new partnering opportunities has been established.

Eisai will continue to disclose information in a proactive and easy-to-understand manner through our corporate website and communicate with all of our stakeholders to help them understand our corporate concept and business activities.

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