Eisai Launches New “Innovation” Page on Corporate Website
Eisai Co., Ltd. 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.
“Innovation” top page www.eisai.com/innovation/index.html
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.
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Japan – Eisai to Present Research from Oncology Portfolio and Pipeline at ESMO Congress 2023
Eisai Co., Ltd. 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(New Window); 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(New Window); 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(New Window); 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.
For more information, visit www.eisai.com/news/2023/news202364.html.
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Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Japan – Eisai: Notice of Absorption-Type Merger (Simplified Merger/Short-Form Merger) of KAN Research Institute, Inc.
Eisai Co., Ltd. hereby announcesthat the Company has today decided to absorb and merge with KAN Research Institute, Inc., the Company’s wholly owned subsidiary on April 1, 2024. Since the Merger is a simplified absorption-typemerger targeting the Company’s wholly owned subsidiary, certain disclosure items and details have been omitted.
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 isredefining the disease concept through comprehensive analysis of the genomic, pathophysiological and clinical information associated with theroot 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 tocreate 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 drugdiscovery 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 tothe innovative creation as a major base of drug discovery research of the Company.
Summary of the Merger:
(1) Schedule of the Merger
Approval of the Merger Agreement by the Executive – October 4, 2023
Signing of the Merger Agreement – October 4, 2023
Date of the Merger (Effective Date) – April 1, 2024
(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 mergerpursuant 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.
For more information, visit https://www.eisai.com/news/2023/pdf/enews202363pdf.pdf.
Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Eisai: Release of Dementia Disease Awareness Videos for World Alzheimer’s Day, September 21
Eisai Co., Ltd. announced today on World Alzheimer’s Day, that it has released a dementia awareness video, “Life Goes On 2023: Two Memories, One Story”, on its dementia information website “Sodan.e-65” and YouTube, which are intended to deepen the understanding of dementia.
With the rapidly aging population, it is predicted that by 2025, one in five people over the age of 65 in Japan will have dementia,(1) and dementia is now something that is familiar to everyone. Symptoms of dementia vary depending on the individual and the disease type that causes it, but the first step toward relieving anxiety of the patient is for others around them to understand their thoughts and the reason behind their symptoms, and to dispel any misunderstandings or assumptions.
This video was produced based on the concept of “learning helps us to be kind”, with the aim of realizing a society where people with dementia and their families can live with peace of mind, by deepening society’s understanding of the disease.
In fiscal 2022, we released “Life Goes On: No Way It’s Not Here” and “Life Goes On: Timeslip”, which depict daily life from the perspective of a mother diagnosed with dementia and her daughter, and have received inquiries from more than 80 local governments, such as requests to use the videos at events.
Life Goes On 2023: Two Memories, One Story
The two met, grew up, became a couple, and started a family. Time passes, and one day the husband forgets if he had eaten or not. The wife notices this and is bewildered.
A story of a couple and their family accepting life with dementia and moving forward.
This video can be viewed (in Japanese only) at https://e-65.eisai.jp/special/lifegoeson_movie/
Eisai will continue to contribute to realize a Dementia Inclusive Society where no one is left behind through creating social impact by building a dementia ecosystem via collaboration with local governments and other industries.
(1) Ministry of Health, Labour and Welfare, Comprehensive Strategy to Accelerate Dementia Measures (New Orange Plan)
https://www.mhlw.go.jp/file/06-Seisakujouhou-12300000-Roukenkyoku/nop1-2_3.pdf (PDF) (Japanese only)
About World Alzheimer’s Day
In 1994, Alzheimer’s Disease International, in collaboration with the World Health Organization, established September 21 every year as “World Alzheimer’s Day” to raise awareness of dementia. In addition, since 2012, September has been designated as “World Alzheimer’s Month,” and various efforts are being made around the world. In Japan, non-profit organization Alzheimer’s Association Japan has been conducting activities such as creating posters and leaflets to promote understanding of dementia.
About “Life Goes On 2023: Two Memories, One Story”
Out-of-home Advertising Campaign
Over the course of 10 days from September 21 (Thursday) to September 30 (Saturday), a full-page hanging advertisement will be displayed all across one train on the Marunouchi Line of the Tokyo Metro.
Making of the Video
Another “Two Memories, One Story”
– Towards a society where everyone can live a better life –
The entire production staff worked on the filming process with the hope of creating an opportunity to think about “the person” before the disease, and to close the distance between society and dementia.
Production Storyboard
A blueprint of the video, that features the movements and emotions of the characters, how to direct the scene, etc.
Further details of the husband’s dementia symptoms and psychological changes are also described in the movies.
About Dementia Information Site “Sodan.e-65”
In addition to the “Forgetfulness Consultation Navigator,” which allows users to search for medical institutions that provide consultation and treatment for dementia, the dementia information site “Sodan.e-65” provides information for everyone living with dementia, including basic knowledge about dementia, measures to maintain and improve cognitive function, care methods, personal experiences, and the dual-task exercise program “Brepacise” (brain performance + exercise) that stimulates both the body and brain. Please see https://e-65.eisai.jp for details (in Japanese only)
Media Inquiries:
Public Relations Department
Eisai Co., Ltd.
+81-(0)3-3817-5120
Topic: Press release summary
Japan – Eisai: FDA Grants Traditional Approval for LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. and Biogen Inc. 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 heathcare 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.
*Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.2,3.4
For more information, visit: www.eisai.com/news/2023/pdf/enews202349pdf.pdf
Media Contacts:
Eisai Co., Ltd.
Public Relations Department TEL: +81 (0)3-3817-5120
Eisai Inc. (U.S.)
Libby Holman
+ 1-201-753-1945
Libby_Holman@eisai.com
Biogen Inc.
Jack Cox
+ 1 781-464-3260
public.affairs@biogen.com
Eisai Europe, Ltd.
(UK, Europe, Australia, New Zealand and Russia) EMEA Communications Department
+44 (0) 786 601 1272
EMEA-comms@eisai.net
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