DSPE Regulatory Update: Acceptance of the European Medicines Agency Submission for an Atypical Antipsychotic Agent Lurasidone

DSPE Regulatory Update: Acceptance of the European Medicines Agency Submission for an Atypical Antipsychotic Agent Lurasidone PR Newswire LONDON, October 25, 2012 LONDON, October 25, 2012 /PRNewswire/ -- Dainippon Sumitomo Pharma Europe Ltd ("DSPE") (Headquarters: London, UK) today announced that the European Medicines Agency (EMA) has confirmed that the Marketing Authorisation Application (MAA) for lurasidone hydrochloride, an atypical antipsychotic investigational medicine for the treatment of schizophrenia, is valid. The MAA was filed by Takeda Global Research & Development Centre (Europe). Dainippon Sumitomo Pharma Co., Ltd ("DSP") discovered and developed lurasidone. Takeda entered into a license agreement with DSP stipulating the joint development and granting of an exclusive commercialisation right of the product to Takeda in 26 member states of the European Union (excluding the United Kingdom), and Switzerland, Norway, Turkey and Russia in March 2011. DSPE will be undertaking the commercialisation of lurasidone in the UK. The MAA submission is based on data from more than 50 clinical trials involving more than 3,800 subjects. Phase 3 clinical trials, demonstrated significantly greater improvement in the primary efficacy endpoint [Positive and Negative Syndrome Scale (PANSS)]* total score in patients with schizophrenia treated with lurasidone administered once daily versus placebo.