Otsuka, Lundbeck to develop investigational vaccine candidate for Alzheimer's disease

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H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that they will further expand their collaboration to include the development of Lu AF20513, an investigational vaccine candidate for Alzheimer's disease.

Lu AF20513 is an anti-Aβ active vaccine candidate for Alzheimer's disease which currently is in preclinical development. It is designed towards an optimal immunogenic response in the elderly, based on the hypothesis that cognitive function would be preserved through the early inhibition of amlyoid beta depositions.

The agreement covers the development of Lu AF20513 through clinical phase I. Following completion of the clinical phase I study the parties have an option to enter into a co-commercialization and co-development agreement under terms to be agreed upon.

Lundbeck will receive from Otsuka an initial payment of EUR 4 million (approximately USD 5.4 million) upon signing and Lundbeck will finance the phase I development costs. Additional specific financial terms of the agreement remain undisclosed.

It is expected that the phase I study will be initiated during 2014.

In addition to the vaccine candidate Lu AF20513, the two companies are pursuing development of two other potential treatments for different symptoms that can occur in patients with Alzheimer's disease -- Lu AE58054, a 5HT6 receptor antagonist for the treatment of cognitive impairment associated with Alzheimer's and brexpiprazole, an investigational agent with high affinity to multiple serotonin, dopamine and norepinephrine receptors for the treatment of agitation in patients with Alzheimer's. Both projects are currently in phase III clinical trials.

These research programs illustrate the depth and breadth of experience and resources the two firms can draw on in neuroscience research and development. The two companies' collective revenues in the central nervous system (CNS) area rank the alliance number one in this fieldiii.

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