H. Lundbeck and Otsuka Pharmaceutical said their existing alliance now also includes development and commercialization of nalmefene (sold under the brand name Selincro in Europe) in Japan. Earlier this year, nalmefene was approved by the EMA as the first treatment for the reduction of alcohol consumption.
Nalmefene is a unique, dual-acting opioid system modulator, and acts on the brain's motivational system, which is dysregulated in patients with alcohol dependence. Nalmefene is thought to reduce the reinforcing effects of alcohol, thereby reducing the urge to drink alcohol.
The harm of alcohol consumption affects individuals, their families, workplaces and society. It is estimated there are approximately 800,000 people in Japan who have been diagnosed with alcohol dependence; an estimated 8.6 million people consume alcohol at harmful drinking levels. In Japan, medical costs associated with alcohol consumption were estimated to be over $40.5 billion per year, of which the direct medical costs are estimated at $10 billion.
Lundbeck will receive an initial payment of $68.8 million upon signing. Lundbeck will finance the development costs and has an option to co-promote the product in Japan. Lundbeck will produce the tablets for the Japanese market and is entitled to sales royalties and sales milestones. If all milestones in the agreement are achieved, the total value of the agreement to Lundbeck would be approximately $137.6 million, plus royalties related to the revenue in Japan.
Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan. It is expected the first phase III study will be initiated during 2014.