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Agreements

Date: 2014-05-09

Type of information: Development agreement

Compound: E2609, BAN2401, BIIB037

Company: Biogen Idec (USA - MA) Eisai (Japan)

Therapeutic area: Neurodegenerative diseases

Type agreement:

development
commercialisation

Action mechanism:

E2609, discovered in-house by Eisai, is an investigational next-generation oral candidate for the treatment of AD that is believed to inhibit BACE, a key enzyme in the production of ABeta. By inhibiting BACE, E2609 decreases ABeta proteins in the brain, potentially improving symptoms and slowing disease progression. Currently, E2609 is undergoing preparations to enter Phase II clinical trials.

BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between Eisai and the swedish company BioArctic Neuroscience AB to identify a potential immunotherapy for AD. BAN2401 is believed to selectively bind to, neutralize and eliminate soluble, toxic ABeta aggregates that are thought to contribute to the neurodegenerative process in AD. As such, BAN2401 has the potential to have an immunomodulatory effect that may suppress the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of AD pursuant to an agreement concluded with BioArctic Neuroscience AB in December 2007. Currently, the compound is undergoing Phase II clinical trials.

BIIB037 is an anti-ABeta human monoclonal antibody that is currently under investigation by Biogen Idec as a treatment for AD under a license from the swiss company Neurimmune. It is believed that BIIB037 binds to and eliminates the toxic amyloid plaques that form in the brains of patients with AD, thereby potentially suppressing the progression of the disease. BIIB037 is currently undergoing a Phase Ib clinical trial.

Disease: Alzheimer’s disease

Details:

* On May 9, 2014, Eisai announced that it has exercised its option to jointly develop and commercialize its clinical candidates for Alzheimer’s disease (AD) with Biogen Idec in Japan. The option was included as part of Eisai’s collaboration agreement with Biogen Idec, which was announced in March 2014. Based on the agreement, Eisai and Biogen Idec will co-develop 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 now Japan. The companies will also co-promote the products following marketing approval. Both companies will share overall costs, including research and development expenses incurred in Japan. Eisai will book all sales for E2609 and BAN2401 following marketing approval and launch, and profits will be shared between the companies. Also, in accordance with the execution of this option, Eisai will receive from Biogen Idec an additional one-time payment as well as the right to receive additional development milestone payments.
* On March 5, 2014, Eisai and Biogen Idec have announced that they have entered into a collaboration to develop and commercialize two of Eisai’s clinical candidates for Alzheimer’s disease (AD), E2609 and BAN2401. The agreement also provides Eisai with an option to jointly develop and commercialize two of Biogen Idec’s candidates for AD, the anti-amyloid beta (Aβ)  antibody BIIB037 and an anti-tau monoclonal antibody. The collaboration initially will be centered on the co-development and co-commercialization of Eisai’s two candidates: E2609, a β-site amyloid precursor protein cleaving enzyme (BACE) inhibitor, and BAN2401, an anti-A? antibody. These candidates have the potential to reduce Aβ plaques that form in the brains of patients with AD and to stop the formation of new plaques, potentially improving symptoms and suppressing disease progression.
Eisai will serve as the operational and regulatory lead in the co-development of E2609 and BAN2401 and will pursue marketing authorizations for both compounds worldwide. In major markets, such as the United States and the European Union, Eisai and Biogen Idec will also co-promote the products following marketing approval. Both companies will share overall costs, including research and development expenses, with Eisai booking all sales for E2609 and BAN2401 and with profits to be split between the companies.

Financial terms:

Biogen Idec will provide Eisai with an upfront payment and a fixed amount of development, approval and commercial milestone payments. The agreement also includes options for Eisai to receive an additional one-time payment from Biogen Idec related to joint development and commercialization activities in Japan.

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