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Agreements

Date: 2013-12-11

Type of information: R&D agreement

Compound: Lu AF20513

Company: Lundbeck (Denmark) Otsuka Pharmaceutical (Japan)

Therapeutic area: Neurodegenerative diseases

Type agreement:

R&D
development
commercialisation

Action mechanism:

Lu AF20513 is an anti-beta-amyloid active vaccine. Lu AF20513 is an active vaccine inducing high affinity polyclonal antibodies that target beta-amyloid (Aß), a protein that can exert toxic effects in the brain and is believed to play a central role in the pathology of Alzheimer’s disease. Lu AF20513 is expected to provide an enhanced and heterogeneous immunogenic response towards Aß peptides in comparison to mono-clonal antibody treatment strategies.

Disease: Alzheimer\'s disease

Details:

* On December 11, 2013, Lundbeck and Otsuka Pharmaceutical have announced that they will further expand their collaboration to include the development of Lu AF20513, an investigational vaccine candidate against Alzheimer’s disease. Lu AF20513 is an active anti-Beta amyloid vaccine candidate against Alzheimer’s disease which currently is in preclinical development. 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-commercialisation and co-development agreement under terms to be agreed upon. 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 the clinical 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 adjunctive treatment of Alzheimer’s disease 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 disease. Both projects are currently in clinical phase III.

Financial terms:

Lundbeck will receive from Otsuka an initial payment of € 4 million (approximately DKK 30 million) upon signing and Lundbeck will finance the phase I development costs. Additional specific financial terms of the agreement remain undisclosed.

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