Takeda withdraws from collaboration with Sumitomo Dainippon for marketing Latuda (lurasidone hydrochloride).

Sumitomo Dainippon Pharma Co., Ltd. and Takeda Pharmaceutical Company Limited jointly announced that their license agreement entered into in March 2011 for the joint development and exclusive commercialization of pharmaceutical products containing lurasidone hydrochloride (Latuda), an atypical antipsychotic agent, in Europe, will be terminated. The companies are starting discussions in an effort to finalize and execute a mutual agreement establishing a transition plan for the orderly transfer of all development and commercialization rights and activities with respect to Latuda to Sumitomo Dainippon Pharma.

Takeda’s right to develop and commercialize Latuda within 26 member states of the European Union (excluding the United Kingdom), Switzerland, Norway, Turkey and Russia, will transfer back to Sumitomo Dainippon Pharma upon the effective date of the termination.

Comment: A new analysis of the phase III, 457 patient, PASTEL Japanese study of the drug in schizophrenia showed that both doses of the drug failed to attain statistical significance against the primary endpoint of the trial. A Phase III clinical study conducted for application for approval of production and distribution of lurasidone for the treatment of patients with bipolar disorder in Japan will continued as planned.

Comment: Latuda is marketed in the US by Sunovion Pharma and is marketed via Takeda in Switzerland, Denmark,Norway,Finland,The Netherlands and marketed in the UK by Sunovion.