Jan 18, 2024 | Business
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.
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Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Jan 12, 2024 | Business
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.
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Dec 20, 2023 | Business
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.
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Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Dec 15, 2023 | Business
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.
Dec 11, 2023 | Business
Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) today announced that the Phase 3 LEAP-001 trial evaluating LENVIMA®, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA®, the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) /MSI-H.　
At the final analysis, KEYTRUDA plus LENVIMA did not improve OS or PFS sufficiently to meet the study’s prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel). The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from this study is ongoing. The companies will work with investigators to share the results with the scientific community.　
“We remain confident in the proven benefit of KEYTRUDA plus LENVIMA for the treatment of appropriate patients with certain types of previously-treated advanced endometrial carcinoma based on results from the KEYNOTE-775/Study 309 trial and will continue to research the KEYTRUDA plus LENVIMA combination in patients with other types of difficult-to-treat cancers,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck & Co., Inc., Rahway, NJ, USA Research Laboratories. “We are disappointed that the LEAP-001 trial did not reach its primary endpoints, as we had hoped to bring another potential treatment option to patients when first diagnosed with certain types of advanced or recurrent endometrial carcinoma.”　
“Results from the LEAP-001 trial underscore the challenges of treating patients with advanced or recurrent endometrial carcinoma in the first-line setting,” said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. “We remain optimistic about clinical development program for LENVIMA plus KEYTRUDA and are proud that the combination has become a standard of care option for patients with certain types of advanced or recurrent endometrial carcinoma whose disease has progressed following prior systemic therapy, and will continue our efforts to contribute to these patients. We are grateful to the patients, their loved ones, and the investigators whose participation is what makes scientific advancement possible.”
LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of certain types of advanced endometrial carcinoma following prior systemic therapy in any setting and advanced renal cell carcinoma (RCC). Lenvatinib is marketed as KISPLYX® for advanced RCC in the EU. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types, including but not limited to hepatocellular carcinoma, RCC, head and neck cancer, gastric cancer and esophageal cancer, across multiple clinical trials.　　
Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.
For more information, visit https://www.eisai.com/news/2023/news202373.html.
Media Contacts:
Eisai Co., Ltd.
Public Relations:
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Investor Relations:
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Merck & Co., Inc., Rahway, NJ, USA
Media Relations
Julie Cunningham: +1-(617) 519-6264
John Infanti: +1-(609) 500-4714
Investor Relations
Peter Dannenbaum: +1-(732) 594-1579
Damini Chokshi: +1-(732) 594-1577
Topic: Press release summary
