Lundbeck has expanded its alliance with Otsuka Pharmaceutical Co to include development and commercialisation of the alcohol dependence drug Selincro in Japan.
Selincro (nalmefene) was approved by the European Medicines Agency earlier this year and the two partners say the first Phase III study for Japan will be initiated during 2014. Under the terms of the agreement, Lundbeck will pocket a 50 million euro fee, finance the development costs and have an option to co-promote in Japan. If all milestones are achieved, the total value of the agreement to the Danish drugmaker, which licensed the drug from Biotie, would be 100 million euros, plus royalties.
It is estimated that there are 800,000 people in Japan who have been diagnosed with alcohol dependence and an estimated 8.6 million consume alcohol at harmful drinking levels. Lundbeck notes that medical costs associated with alcohol consumption were estimated to be over 4 trillion yen (30 billion euros) per year of which the direct medical costs are estimated at 1 trillion yen.
Otsuka president Taro Iwamoto noted that damage to peoples' health from alcohol dependency has become a very important issue in Japan. 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".
His counterpart at Lundbeck, Ulf Wiinberg, said that "there is a clear unmet need for treatment opportunities for the reduction of alcohol consumption also in Japan". He added that "we have now introduced the product in 17 European countries and the feedback so far is encouraging".