Lundbeck, Otsuka reach agreement to develop and commercialize Lu AE58054

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced a license and development agreement for Lu AE58054, a selective 5HT₆ receptor antagonist currently in development for the treatment of Alzheimer's disease. Under the terms of 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.

“There is a serious, global, unmet medical need regarding treatments for Alzheimer's disease in aging populations. Together, Otsuka and Lundbeck with their development capabilities, commercial experience and geographical reach will provide a solid foundation in the development of Lu AE58054.”

Under the terms of the agreement, Lundbeck will receive from Otsuka an initial payment of USD 150 million (approximately DKK 855 million) upon signing. Both companies will share the sales, development, and commercialization costs based on the agreement. Lundbeck is also entitled to up to USD 675 million (approximately DKK 3.9 billion) in regulatory and sales milestones. Additional specific financial terms of the agreement remain undisclosed.

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd., noted with respect to Lu AE58054 "The global collaboration between Otsuka and Lundbeck continues to grow stronger with the addition of Lu AE58054. 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."

Ulf Wiinberg, President & Chief Executive Officer of Lundbeck commented "There is a serious, global, unmet medical need regarding treatments for Alzheimer's disease in aging populations. Together, Otsuka and Lundbeck with their development capabilities, commercial experience and geographical reach will provide a solid foundation in the development of Lu AE58054."

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 towards the end of 2013.

In May 2012, it was announced that Lu AE58054 had met its primary endpoint in a fixed dose, randomized, placebo-controlled, 24-week clinical study in 278 patients. The study was conducted in patients suffering from moderate Alzheimer's disease, with Lu AE58054 administered as an add-on to donepezil, a commonly used acetylcholinesterase inhibitorⁱ. The clinical data from the phase II study is planned to be presented at the annual Alzheimer's Association International Conference (AAIC) in Boston on 13-18 July 2013.