Japanese pharma company Otsuka has licensed an Alzheimer’s disease drug candidate from Lundbeck in a deal that expands an ongoing collaboration between the two companies to include a third drug.
The agreement – which includes $150m in upfront licensing fees and $675m in development, regulatory and commercial milestones – is for Lu AE58054, a selective serotonin 5-HT6 receptor antagonist which is due to start pivotal trials in more than 2,500 patients later this year.
The first phase III study will look at the use of Lu AE58054 in patients with mild-to-moderate Alzheimer’s disease who are also being treated with donepezil, an acetylcholinesterase inhibitor originally developed by Eisai under the Aricept brand name and is now available as a generic in most markets.
5HT6 receptors are found almost exclusively in the central nervous system and are particularly prevalent in areas of the brain involved in learning and memory, including the striatum, hippocampus and cerebral cortex.
Studies have shown that antagonists of the receptor stimulate the release of the neurotransmitters acetylcholine and glutamate at neuronal junctions, which could boost nerve function and complement the mechanism of action of drugs such as donepezil.
Lundbeck announced last year that a phase II study showed Lu AE58054 had met its primary objective as an add-on to donepezil therapy over a 24-week treatment period, and these data will be presented in full at the Alzheimer’s Association International Conference (AAIC) in Boston, US, in July.
Otsuka gains co-development and co-commercialisation rights to Lu AE58054 in the US, Canada, East Asia including Japan, major European countries and Nordic countries, said the two companies in a statement.
The two companies have been collaborating in the area of CNS treatments since 2011, and recently revised the terms of their alliance following the approval of once-monthly schizophrenia treatment Abilify Maintena (aripiprazole) in the US. They are also working on the development of an aripiprazole follow-up called brexipiprazole, which has reached phase III development.
GlaxoSmithKline is also working in the 5ht6 receptor antagonist area and has advanced candidate (SB742457) into phase II trials, while Pfizer also has a compound (PF-05212377; also known as SAM-760) mid-stage clinical development.