FDA Grants Fast Track Designation for Development of E2609, Eisai's BACE Inhibitor for Early Alzheimer's Disease

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Nov 17, 2016, 09:05 ET

WOODCLIFF LAKE, N.J., Nov. 17, 2016 /PRNewswire/ -- Eisai Inc. announced today that it has received U.S. Food and Drug Administration (FDA) Fast Track designation for the development of E2609, a Beta-secretase Cleaving Enzyme (BACE) inhibitor currently being evaluated in Phase 3 clinical trials for early Alzheimer's disease. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen as a potential Alzheimer's disease (AD) modifying treatment.

The FDA's Fast Track program is intended to facilitate the development and review of new therapies to treat serious conditions and tackle key unmet medical needs by allowing for frequent interactions with FDA. It may also enable priority review by FDA if supported by clinical data at the time of NDA submission.

"We are excited that the FDA has granted Fast Track designation to E2609," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "We look forward to working closely with the FDA to expedite this clinical program and hope to offer an important treatment option for patients who suffer from early Alzheimer's disease."

Discovered in-house by Eisai, E2609 is an investigational next-generation oral candidate for the treatment of AD that inhibits BACE, a key enzyme in the production of amyloid beta (Aβ) peptides. By inhibiting BACE, E2609 may decrease the formation of toxic Aβ peptide aggregates and amyloid plaques in the brain, thereby potentially slowing disease progression. The first Phase 3 study for E2609 in the clinical trial program called MISSIONAD began in October 2016 and will enroll 1,330 patients with biomarkers confirmed for early Alzheimer's disease.

This release discusses an investigational agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that this investigational agent will successfully complete clinical development or gain FDA approval.

About the Collaboration Agreement between Eisai and Biogen
Based on a collaboration agreement, Eisai and Biogen will co-develop and, if approved, co-promote Eisai's investigational next generation AD treatment candidates E2609, a BACE inhibitor, and BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, in major markets, such as the United States, the European Union and Japan. Both companies will share overall costs, including research and development expenses. Eisai will book all sales for E2609 and BAN2401 following marketing approval and launch, and profits will be shared between the companies. Also, Eisai has received from Biogen an additional one-time payment as well as the right to receive additional development milestone payments. Under the same agreement, Eisai also holds options to jointly develop and commercialize two of Biogen's candidates for Alzheimer's disease, the anti- Aβ antibody aducanumab and an anti-tau antibody.

About Eisai Inc.
As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we are a fully integrated pharmaceutical business with discovery, clinical, and marketing capabilities. Our key areas of focus include oncology and neurology (dementia-related diseases and neurodegenerative diseases). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based pharmaceutical company that discovers, develops and markets products worldwide. Guided by its corporate mission of "giving first thought to patients and their families, and to increasing the benefits that health care provides," all Eisai employees aspire to meet the various needs of global health care as representatives of a "human health care (hhc) company" that is capable of making a meaningful contribution under any healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com/.