Takeda links with Dainippon Sumitomo on two licensing deals; makes European management appointments

Japanese drugmaker Dainippon Sumitomo Pharma (4506: JP) has entered into a licensing accord with Takeda Pharmaceutical (TSE: 4502) for the joint development and exclusive commercialization of the oral formulation of lurasidone, an atypical antipsychotic agent developed originally by DSP, for the treatment of schizophrenia and bipolar disorder.

The deal covers 26 European Union member states (excluding the UK), as well as Switzerland, Norway, Turkey and Russia. Takeda, Japan’s largest drugmaker, will make an upfront payment of 10 billion yen ($123.3 million) and milestones up to around $180 million in the event of a Marketing Authorization Application filing and MAA approval for targeted indications: schizophrenia and bipolar disorder. Upon commercialization, Takeda will pay royalty to DSP based on net sales in the assigned territories, and DSP will supply the product to Takeda. In addition, after the execution of this agreement, future development costs necessary for MAA filing and its approval in the territory will be shared between DSP and Takeda at a certain fixed ratio. Further details of the financial terms were not disclosed.

Lurasidone was approved for the treatment of schizophrenia in adult patients in the USA by the Food and Drug Administration in October 2010. The two companies will aim for the earliest possible MAA filing of lurasidone in the territory with joint development based on the global studies carried out by DSP. In regard to a future MAA filing, consultation is on-going to determine whether additional clinical studies are necessary before the MAA for either of the two targeted indications can be submitted to the European Medicines Agency.