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Otsuka named as Lundbeck’s partner in Japan on Nalmefene

Danish Lundbeck and Japanese Otsuka Pharmaceutical have announced that the companies’ existing alliance now also includes the development and commercialization of Nalmefene in Japan.

Under the terms of the agreement, Lundbeck will receive an initial payment of EUR 50 million from Otsuka upon signing. Lundbeck will finance the development costs and has an option to co-promote the product in Japan. Furthermore, Lundbeck will produce the tablets for the Japanese market and is entitled to sales royalties and sales milstones. If all milestones in the agreement are achieved, the total value of the agreement to Lundbeck would be approximately EUR 100 million (approximately DKK 745 million), plus royalties related to the revenue in Japan.

Nalmefene is a dual-acting opioid system modulator and acts on the brain’s motivational system which is dysregulated in patients with alcohol dependence. According to Lundbeck, Nalmefene is thought to reduce the reinforcing effects of alcohol, and thereby reduces the urge to drink alcohol.

Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan. It is expected that the first clinical phase III study will be initiated during 2014.

“There is a clear unmet need for treatment opportunities for the reduction of alcohol consumption also in Japan. We have now introduced the product in 17 European countries and the feedback so far is encouraging. Together with our partner we look forward to bringing this treatment to Japan as well,” said Ulf Wiinberg, President and CEO of Lundbeck.

In November 2011 Lundbeck and Otsuka established a global collaboration to bring to patients therapies for better mental health. This collaboration is now strengthened with the inclusion of nalmefene in Japan.