Global pharmaceutical company H. Lundbeck and global healthcare company Otsuka Pharmaceutical have formed 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 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. In return, Lundbeck will receive an initial payment of $150 million upon signing. Both companies will share the sales, development, and commercialization costs based on the agreement. Lundbeck is also entitled to up to $675 million in regulatory and sales milestones. Additional specific financial terms of the agreement remain undisclosed.

“The global collaboration between Otsuka and Lundbeck continues to grow stronger with the addition of Lu AE58054,” said Taro Iwamoto, president and representative director of Otsuka Pharmaceutical. “Not only does the product further enhance the synergy between the companies as we work together to bring to the market solutions for better health, Lu AE58054 is a potentially promising development in a very difficult disease area.”

The pivotal clinical program with Lu AE58054 is planned to be initiated later in 2013. 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. Subsequent studies are expected to be initiated toward the end of 2013.

In May 2012, Lu AE58054 met its primary endpoint in a fixed dose, randomized, placebo-controlled, 24-week clinical study in 278 patients. The study was conducted in patients with moderate Alzheimer's disease, with Lu AE58054 administered as an add-on to donepezil, a commonly used acetylcholinesterase inhibitori.