Eisai Alzheimer's Disease Pipeline Research to be Presented at Virtual AD/PD™ 2021, Including Lecanemab (BAN2401) Data

WOODCLIFF LAKE, N.J., March 5, 2021 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today the presentation of data and information from the company's robust Alzheimer's disease (AD) pipeline, including lecanemab (BAN2401). Jointly developed by Eisai and Biogen Inc., lecanemab is an investigational humanized monoclonal antibody that binds to neutralize and eliminate soluble, toxic amyloid beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. This data will be among Eisai's many presentations at AD/PD™ 2021 Virtual Conference, the 15^th International Conference on Alzheimer's and Parkinson's Diseases, March 9 - 14, 2021.

"Alzheimer's disease is a progressively debilitating and devastating neurodegenerative disease. The focus on Alzheimer's disease has historically been on alleviating cognitive and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease through the science of biomarkers. We look forward to sharing data and discussing the scientific rationale that the amyloid beta pathway plays a key role in the pathophysiology of Alzheimer's disease," said Harald Hampel, M.D., Ph.D., Vice President, Chief Medical Officer, Neurology Business Group, Eisai Inc., who was recently named one of the world's top five Alzheimer's disease experts by Expertscape based on objective ranking of his contribution and impact on the Alzheimer's field through scientific publications. 

Eisai and Biogen Joint Investigational Assets

Eisai Oral Presentation for Lecanemab:

• Preliminary findings for lecanemab, a humanized lgG1 that selectively binds to Aβ protofibrils, to evaluate the longitudinal amyloid positron emission tomography (PET) findings across the Core, GAP period between end of Core and Open-Label Extension (OLE) baseline and OLE in subjects who participated in the Core and OLE amyloid imaging subgroups. These results will be presented on March 13.

Biogen Oral Presentations for Aducanumab:

• Cerebrospinal Fluid (CSF) Biomarker Concordance with Amyloid PET in EMERGE/ENGAGE, Phase 3 Studies of Aducanumab in Patients with Early Alzheimer's Disease. These results will be presented on March 10.
• Evaluation of Aducanumab Efficacy in Early Alzheimer's Disease. These results will be presented on March 13.
• Evaluation of Aducanumab Safety in Early Alzheimer's Disease. These results will be presented on March 13.

Select Eisai-Only Presentations

• The effects of E2027 on cognitive impairment in a mouse model of AD. Eisai is developing E2027, a selective phosphodiesterase (PDE) 9 inhibitor, as a potential treatment for dementia with Lewy bodies. Inhibiting PDE9 increases cGMP, which is involved in synaptic plasticity and cognitive function, and it is believed to be a target for memory improvement.
• Additional studies using electronic health records from the U.S. Veterans' Affairs (USVA) health care system explore:
• Epidemiology of mild cognitive impairment, AD and AD-related dementia over the past 20 years;
• USVA health care system's capacity and readiness for AD disease-modifying therapies;
• Association of selected long-term medication use on the risk of occurrence of possible AD

Eisai and Sysmex Presentation

• A Fully Automated Plasma Aβ Assay Incorporating APOE4 Status Shows High Performance to Predict Amyloid Positivity Determined by Centiloids of Amyloid PET. These results will be presented on March 12.

Virtual Symposium: The Science Behind the Aβ Pathway in AD

Eisai and Biogen are hosting a symposium focusing on the central role of the Aβ pathway in the pathophysiology of AD. Expert faculty provide a comprehensive overview of the cross-disciplinary evidence supporting the loss of Aβ homeostasis as an early pathophysiological event within the AD biological-clinical continuum. There will also be a short state-of-the-art presentation of the in vivo biomarkers of Aβ. Featured speakers will include:

• Jeffrey Cummings, M.D.
• John Hardy, Ph.D.
• Colin Masters, M.D.
• Philip Scheltens, M.D., Ph.D.

"With Eisai's and Biogen's joint asset, aducanumab, under regulatory review in the U.S., European Union and Japan, the companies' joint asset, lecanemab, in Phase 3 Clarity-AD and AHEAD 3-45 clinical studies and the data presented at this year's ADPD, it is an incredibly exciting time for Eisai's growing Alzheimer's disease franchise," said Ivan Cheung, Chairman, Eisai Inc. and Global President, Neurology Business Group, Eisai Co., Ltd. "Eisai is dedicated to advancing our robust pipeline of novel investigational therapies targeting the disease pathophysiology as well as its clinical symptoms."

The full list of virtual presentations is included below. All presentations will be available to registered participants via the AD/PD™ 2021 virtual platform the start of the meeting and for three months afterward.

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.

[Notes to editors]

1. About Lecanemab (BAN2401)
   Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017.
                      
   Currently, lecanemab is being studied in a pivotal Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase II clinical study (Study 201). In July of 2020, the Phase III 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, was initiated. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium, funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai.
                     
2. About the Joint Development between Eisai and Biogen for Alzheimer's Disease
   Eisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Biogen serves as the lead in the co-development of aducanumab and Eisai serves as the lead in the co-development of lecanemab, anti-amyloid beta (Aβ) protofibril antibodies, and the companies plan to pursue marketing authorizations for aducanumab and lecanemab worldwide. If approved, the companies will also co-promote aducanumab and lecanemab in major markets, such as the United States, the European Union and Japan. Both companies will equally split overall costs, including research and development expenses. Eisai will book all sales for lecanemab following marketing approval and launch, and profits will be equally shared between the companies.
                                    
3. About the Collaboration between Eisai and BioArctic for Alzheimer's Disease
   Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.
                                     
4. About E2027
   Discovered by Eisai, E2027 is a selective phosphodiesterase (PDE) 9 inhibitor. Inhibiting PDE9 reduces the degradation of cyclic GMP (cGMP) which is critical to signal transmission among cells, and helps maintain the concentration of cGMP in the brain. Eisai is currently developing E2027 as a new treatment for dementia with Lewy bodies.
                                 
5. About the Collaboration between Eisai and Sysmex
   Eisai and Sysmex have entered into a comprehensive non-exclusive collaboration agreement aimed at the creation of new diagnostics in the field of dementia in February 2016. Leveraging each other's technologies and knowledge, the two companies aim to discover next-generation diagnostics that will enable early diagnosis, selection of treatment options and the regular monitoring of the effects of treatment for dementia.
                                    
6. About Eisai Inc.
   At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.

Contact:
Eisai Inc.
Libby Holman
201-753-1945
[email protected]        

SOURCE Eisai Inc.