Eisai: “LEQEMBI” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in China

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (generic name: lecanemab-irmb) has been approved in China as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. Preparations for launch within the second quarter of Eisai’s FY 2024 (July 1 – September 30, 2024) are underway.

LEQEMBI selectively binds to soluble 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. China is the third country to grant marketing approval, following the traditional approval in the U.S. in July 2023 and Japanese approval in September 2023.

LEQEMBI’s approval in China is based on the large global Phase III Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

Eisai estimates that there will be 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to increase with the aging of the population. Eisai will distribute the product in China and will conduct information provision activities through specialized Medical Representatives. Moving forward, Eisai will focus on AD awareness via omnichannel systems and collaborate with specialists to improve the diagnostic environment, including blood-based biomarkers. In addition, by utilizing online health platform for the elderly “Yin Fa Tong”**, which is already being accessed by a certain number of users and helping provide treatments, Eisai is providing a one-stop service that promotes early consultation by referring patients to medical specialists and follow-up after treatment. In addition, Eisai will work to improve access environments including the development of insurance programs for AD in collaboration with insurance companies. Through these efforts, Eisai will accelerate the construction of a simple patient journey in China.

* Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.1,2,3.
** An online business of Jingyi Weixiang (Shanghai) Health Industry Development Limited Company, a joint venture company with JD Health.

For more information, visit https://www.eisai.com/news/2024/news202403.html. 

MEDIA CONTACTS

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

Biogen Inc.
Jack Cox
+ 1-781-464-3260
public.affairs@biogen.com


Topic: Press release summary

Japan – Eisai Listed as a Global 100 Most Sustainable Corporation for the Eighth Time

Eisai Co., Ltd. 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

Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Japan – Eisai: The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI®), which is currently under review by the European Medicines Agency (EMA). The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024.

The SAG is convened at the request of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation by the CHMP, or on other scientific issues relevant to the work of the CHMP.

Eisai expects the European Commission’s decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG.

Eisai serves as the lead of lecanemab 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.

About Lecanemab (generic name, brand name: LEQEMBI®)

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted traditional approval by the U.S. Food and Drug Administration (FDA) on July 6, 2023. LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023, to manufacture and market LEQEMBI as a treatment for slowing progression of MCI and mild dementia due to AD. Furthermore, in China, LEQEMBI was approved by the National Medical Products Administration (NMPA) as a treatment of mild cognitive impairment (MCI) due to AD and mild AD dementia on January 5, 2024.

Eisai has also submitted applications for approval of lecanemab in Canada, Great Britain, Australia, Switzerland, South Korea and Israel in addition to EU. In Israel the application has been designated for priority review, and in Great Britain lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.

Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is still being evaluated in the Clarity AD (Study 301) open-label extension (OLE). A maintenance dosing regimen has been evaluated as part of Study 201.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.

Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the Collaboration between Eisai and Biogen for AD

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

About the Collaboration between Eisai and BioArctic for AD

Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market LEQEMBI for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody LEQEMBI back-up was signed in May 2015.

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

Japan – Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, “tasurgratinib”) for biliary tract cancer with FGFR2 gene fusion. In Japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, (MHLW). Under this system, this application will be subject to priority review.

This application is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 201) in Japan and China conducted by Eisai. Study 201 enrolled patients with unresectable biliary tract cancer with FGFR2 gene fusion previously treated with gemcitabine-based combination chemotherapy. The primary endpoint of this study was objective response rate, and secondary endpoints included safety. Detailed results of the study will be presented at upcoming academic conferences.

The estimated number of patients with biliary tract cancer is approximately 25,000 in Japan1, 2 and the five-year survival rate for the cancer is approximately 25%, which makes it an intractable cancer with the second worst prognosis following pancreatic cancer.1 Drug therapy options are limited in comparison with other cancers, and as such it is a disease with significant unmet medical needs. FGFR2 gene fusion is observed in approximately 14% of intrahepatic cholangiocarcinoma, which account for 15-30% of biliary tract cancers.3 FGFR genetic aberrations such as the gene fusions are known to be deeply involved in the proliferation, survival and migration of cancer cells as well as tumor angiogenesis and drug resistance. As these genetic aberrations in FGFRs have been observed in various other types of cancers including biliary tract cancer, there is growing interest in FGFRs as a promising target for cancer therapy. By selectively inhibiting FGFR1, 2 and 3, and blocking those signals, tasurgratinib has been expected to become a new molecular targeted therapy for cancers with FGFR genetic aberrations.4

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.

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

Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Japan – Eisai and Mizuho Sign Sustainability-Linked Loan Agreement

Eisai Co., Ltd. and Mizuho Bank, Ltd. announced today that the companies have signed a sustainability-linked syndicated loan agreement, which comes into effect today.

Sustainability-linked loans are a type of loan which incentivizes borrowers to achieve sustainability performance targets (“SPTs”) by linking borrowing terms and conditions, such as interest rates, to the achievement of the SPTs, seeking to drive environmental and socially sustainable economic activities and economic growth.

Under the concept of human health care (hhc), Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. through activities such as innovative drug discovery in the fields of dementia, cancer, and global health. Particularly in the domain of dementia, Eisai has developed “LEQEMBI®”, a new drug for Alzheimer’s disease(AD), which obtained approval in the US and Japan this year. By delivering LEQEMBI to people with early AD around the world, Eisai aims not only to improve their health outcomes but also contribute to address social issues regarding AD, including long term nursing care.

Eisai has set social impact targets for LEQEMBI in the U.S. and Japan based on its social value in terms of its effects on health outcomes and on cost reductions in nursing care and other expenses, and has established these as the SPTs of this agreement. With the funds raised through this agreement, Eisai will promote the creation of social impact through the elimination of diseases of poverty (neglected tropical diseases, malaria, tuberculosis, etc.), in addition to the establishment of programs to offer LEQEMBI to low-income populations for free in the U.S. and emerging countries, and the building of dementia ecosystems.

This agreement has undergone a third-party review* by Rating and Investment Information, Inc. (R&I) regarding its compliance with the Sustainability-Linked Loan Principles issued by the Loan Market Association and other organizations, as well as the Green Loan and Sustainability-Linked Loan Guidelines issued by Japan’s Ministry of the Environment.

Mizuho Bank is committed to the Mizuho group’s purpose of “proactively innovate together with our clients for a prosperous and sustainable future”, with the desire to co-create a prosperous future with clients by supporting their endeavors and challenging ourselves. Mizuho’s new medium-term business plan, which began in FY2023, is a three-year journey connecting various initiatives and co-creating value-added solutions in order to support our clients and solve social issues. As part of this, we are seeking out ways to have positive social impacts in areas such as realization of a more inclusive society and improvement in Japan’s global competitiveness.

Mizuho Bank’s role in connecting initiatives and creating social impact and outcomes is to support sustainability transformation from multiple angles by working together to find solutions for the development of clients and society from a medium- to long-term perspective.

Mizuho Bank will continue working together with our clients to achieve sustainability transformation by providing sustainable finance that creates a flow of funds to address environmental and social issues, and by providing solutions that utilize knowledge and functions that go beyond finance.

Overview of Loan Terms

Borrower: Eisai
Method: Syndication
Arranger: Mizuho Bank
Lenders: 39 financial institutions
Loan amount: 50 billion yen
Agreement date: December 6, 2023
Drawdown date: December 13, 2023

* Please refer to the opinion provided by Rating and Investment Information, Inc. (R&I).

Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.