Lundbeck, Otsuka Pharmaceutical expand alliance

Companies will develop, commercialize alcohol dependence treatment in Japan

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VALBY, Denmark—H. Lundbeck A/S and Otsuka Pharmaceutical Co. Ltd. have announced a change to their existing alliance, which now covers the development and commercialization of nalmefene, a treatment for the reduction of alcohol consumption, in Japan. Nalmefene, known as Selincro in Europe, gained European Medicines Agency approval earlier this year. The companies first announced a global collaboration focused on mental health therapies in November 2011.
“There is a clear unmet need for treatment opportunities for the reduction of alcohol consumption also in Japan,” said Ulf Wiinberg, president and CEO of Lundbeck, in a press release. “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.”
Per the terms of the agreement, Otsuka will pay Lundbeck 50 million euros (approximately $67.9 million) upon signing, and Lundbeck will be responsible for development costs and will produce the tablets for the Japanese market. For its part, Lundbeck will be entitled to sales royalties and sales milestones, and has an option to co-promote the product in Japan. Should all milestones be achieved, the deal has a potential total value of 100 million euros (approximately $135.9 million) for Lundbeck, plus royalties related to revenue in Japan. The partners will jointly finalize the clinical program for the drug in Japan, with expectations that the first clinical Phase III study will begin in 2014.
“Damage to peoples’ health from alcohol dependency has become a very important issue in Japan,” Dr. Taro Iwamoto, president and representative director of Otsuka Pharmaceutical, commented in a statement. “Therefore, this novel concept for dependency based on as-needed administration of therapy can reshape the treatment for patients who cannot or do not want to completely stop drinking. It is also a great strategic fit with Otsuka’s and Lundbeck’s global prominence in CNS disorders.”
Nalmefene is indicated as an aid for reducing alcohol consumption in patients with alcohol dependence and a high drinking risk level but without physical withdrawal symptoms and no need for immediate detoxification. The therapy, a unique dual-acting opioid system modulating, acts on the brain’s motivational system and is believed to decrease alcohol’s reinforcing effects and the urge to drink.
Current estimates are that some 800,000 people in Japan have been diagnosed with alcohol dependence, with an estimated 8.6 million people drinking at harmful levels. Additionally, only an estimated 3 to 6 percent of those affected are currently receiving some kind of treatment. Medical costs for the country related to drinking are estimated at more than 4 trillion yen (approximately $40.5 billion) each year, of which direct medical costs are believed to be roughly 1 trillion yen (approximately $10.1 billion).

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