Eisai has announced a positive progression for its Alzheimer's drug, E2609, which can be advanced to Phase III clinical studies following confirmation from the US Food and Drug Administration (FDA) that there was sufficient data to support the drug's clinical-trial progression. E2609 is an investigational oral beta-secretase cleaving enzyme (BACE) inhibitor that was discovered by Eisai and is being jointly developed by Eisai and Biogen for early Alzheimer’s disease. Following this discussion with the FDA on the Phase III clinical-study designs, Eisai and Biogen intend to have similar discussions with the regulatory authorities in Japan and the European Union (EU) and to conduct the study as a global, multicenter study.

Based on their agreement, Eisai and Biogen are co-developing E2609, and BAN2401, an anti-Aβ protofibril antibody, in major markets, such as the US, the EU, and Japan. Upon regulatory approval, the companies will co-promote the products. 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.

Eisai has received from Biogen an additional one-time payment as well as the right to receive additional development milestone payments. 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.

Source: Eisai