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DSP and Takeda Announce the Acceptance of the European Medicines Agency Submission of an Atypical Antipsychotic Agent Lurasidone
Date:10/25/2012

OSAKA, Japan, October 25, 2012 /PRNewswire/ --

Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Headquarters: Osaka, Japan) and Takeda Pharmaceutical Company Limited ("Takeda") (Headquarters: Osaka, Japan) today announced that the European Medicines Agency (EMA) has confirmed the acceptance for review of the Marketing Authorization Application (MAA) for an atypical antipsychotic medication lurasidone hydrochloride for the treatment of schizophrenia. The MAA was filed by Takeda Global Research & Development Centre (Europe).

Lurasidone, orally administrated once daily, is an atypical antipsychotic medication discovered and developed by DSP with a unique chemical structure as compared to other existing antipsychotic medicines. Takeda entered into a license agreement with DSP stipulating the joint development and grant of an exclusive commercialization 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.

The MAA submission is based on the data from more than 50 clinical trials involving more than 3,800 lurasidone-treated subjects. In phase 3 clinical trials, in which the efficacy and safety of lurasidone in the treatment of patients with schizophrenia were evaluated, lurasidone demonstrated significantly greater improvement versus placebo in the primary efficacy endpoint [Positive and Negative Syndrome Scale (PANSS)* total score]. The most commonly observed adverse reactions in patients treated with lurasidone were somnolence, akathisia, nausea and parkinsonism. Clinical trials also demonstrated that lurasidone was well-tolerated with minimal impact on weight or metabolic parameters.

"Lurasidone is the DSP Group's core product for overseas expansion, and I am very pleased that we have achieved the important milestone of submitting an MAA in Europe." said Masayo Tada, President and Chief Executive Officer of DSP. "Through the cooper
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SOURCE Takeda Pharmaceutical Company Limited and Dainippon Sumitomo Pharma Co., Ltd.
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