H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co Ltd. (Otsuka) has 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-Aβ vaccine candidate against 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 amyloid 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-commercialisation and co-development agreement under terms to be agreed upon.
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.
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.
These 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 field.
The content of this release will have no influence on the Lundbeck Group’s financial guidance for 2013, which was provided on 6 November.
About Lu AF20513
Lu AF20513 is an active vaccine inducing high affinity polyclonal antibodies that target beta-amyloid (Aβ), 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 Aβ peptides in comparison to mono-clonal antibody treatment strategies.