Lundbeck to earn up to US $825m for its Alzheimer’s drug

Hannah Blake

pharmaphorum

Danish pharma company Lundbeck has announced a license and development agreement with Otsuka Pharmaceutical Co., Ltd. The agreement could earn Lundbeck up to US $825 million for its Alzheimer’s disease drug, Lu AE58054.

Lu AE58054 is a selective 5HT6 receptor antagonist that recently met its primary endpoint in phase 2 clinical trials of 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 inhibitor.

Under terms of this agreement, Lundbeck will grant Otsuka co-development and co-commercialisation rights to Lu AE58054 in the US, Canada, East Asia, major European countries and also Nordic countries. Lundbeck is to receive an initial payment of $150 million from Otsuka and is then entitled up to $675 million in regulatory and sales milestones.

"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."

Ulf Wiinberg, President &amp, Chief Executive Officer of Lundbeck.

A global phase 3 clinical trial program evaluating Lu AE58054 and including over 2500 patients with mild-to-moderate Alzheimer's disease is planned to be launched later in 2013.