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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

ation between our two companies, we are aiming for the swiftest approval in order to provide this drug to more patients as soon as possible."

"We are very pleased with the submission of lurasidone in the E.U.," said Yasuchika Hasegawa, president & CEO of Takeda. "We believe the submission will lead to the enhancement of our central nervous system franchise, one of our core therapeutic areas. Once approved, we believe we can contribute to the treatment of patients with schizophrenia."

* A medical scale used for mainly measuring symptom severity of patients with schizophrenia. It consists of 30 items---7 items of positive scale, 7 items of negative scale and 16 items of general psychopathology scale. Each item is rated from 1 (absent) to 7 (extreme).

About lurasidone

Lurasidone is an atypical antipsychotic, developed originally by DSP with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects.  In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors.

Lurasidone (brand name LATUDA®) was approved for the treatment of schizophrenia by the United States Food and Drug Administration on 28 October 2010 and by Health Canada on 13 June 2012.  LATUDA was launched in the United States for the treatment of schizophrenia in adults on February 4, 2011 (US time) and in Canada on September 17, 2011 (Canada Time) through DSP's subsidiary Sunovion Pharmaceuticals Inc.  

In the U.S. and Canada, the recommended starting dose for LATUDA is 40mg/day taken with food (at least 350 calories) with no initial dose titration required.  The maximum recommended dose is 160 mg/day.  The efficacy of lurasidone for the treatment of schizophrenia was established in five, short-term (6-week), placebo-controlled clinical studies in adult patients who met DSM-IV criteria for
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SOURCE Takeda Pharmaceutical Company Limited and Dainippon Sumitomo Pharma Co., Ltd.
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