H. Lundbeck and Otsuka Pharmaceutical entered a license and development agreement for Lu AE58054, a selective 5HT6 receptor antagonist currently in development for the treatment of Alzheimer's disease. Lundbeck will receive an initial payment of $150 million from Otsuka upon signing and is also entitled to up to $675 million in regulatory and sales milestones. Both companies will share the sales, development, and commercialization costs.
Under the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in the U.S., Canada, East Asia including Japan, major European countries, and Nordic countries.
The clinical program with Lu AE58054 is planned to be begin later this year. The global program will consist of several studies and include more than 2,500 patients. The first Phase III study will enroll patients with mild-to-moderate Alzheimer's disease. Lu AE58054 will be tested as adjunct treatment to donepezil.
In May 2012, Lu AE58054 met its primary endpoint in a fixed-dose, randomized, placebo-controlled, 24-week clinical study in 278 patients, according to the company. The study was conducted in patients with moderate Alzheimer's disease. Lu AE58054 was administered as an add-on to donepezil, a commonly used acetylcholinesterase inhibitor.