Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has expanded its existing alliance with Otsuka Pharmaceutical Co. Ltd. (Otsuka) to include development and commercialization of nalmefene (sold under the brand name Selincro in Europe) in Japan.
Earlier this year, nalmefene was approved by the European Medicines Agency as the first treatment for the reduction of alcohol consumption. Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan, and it is expected that the first clinical Phase 3 study will be initiated during 2014.
Biotie has licensed global rights to nalmefene to Lundbeck. In September 2012, in connection with Lundbeck making a EUR 10 million equity investment in Biotie, the worldwide license agreement regarding nalmefene was amended whereby the royalties on the sales on markets outside the European Union, the European Free Trade Area and the United States were decreased in order to support the possible launching of the product for these markets, and Biotie is to receive an additional sales milestone payment in the amount of EUR 5 million in Japan. Today’s announcement will have no immediate financial impact on Biotie.
Timo Veromaa, president and chief executive officer of Biotie commented: “We are delighted that Lundbeck together with Otsuka are committed to launching nalmefene in Japan. Alcohol dependence is a worldwide problem and nalmefene with its as-needed administration of therapy can reshape the treatment for patients who cannot or do not want to completely stop drinking.”
Date: October 31, 2013
Filed Under: Drug Discovery