OTSUKA HOLDINGS CO., LTD. 
By
Company name Otsuka Holdings Co., Ltd. Representative Tatsuo Higuchi
President and Representative Director, CEO Code number 4578 First Section , Tokyo Stock Exchange Inquiries Takuma Kimura
Director, Investors Relations Department
January 24, 2014
Otsuka Pharmaceutical Co., Ltd., a subsidiary company of Otsuka Holdings Co., Ltd., and H. Lundbeck A/S today announced that the first phase III data on their investigational compound brexpiprazole will be presented in an upcoming poster session at the 22nd European Psychiatry Association Congress (EPA) on March 2, 2014.
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(Tokyo, Japan and Copenhagen, Denmark, Friday, January 24, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the first phase III data on their investigational compound brexpiprazole will be presented in an upcoming poster session at the 22nd European Psychiatry Association Congress (EPA) on March 2, 2014.
Data will be presented from a completed phase III, randomized, placebo-controlled study investigating the effect of brexpiprazole as adjunctive therapy to antidepressant therapy in patients with major depressive disorder (MDD). Overall, brexpiprazole demonstrated efficacy and was well tolerated as an adjunctive treatment for MDD patients with an inadequate response to antidepressant treatment.
At the EPA congress, highlighted data on brexpiprazole as adjunctive therapy to anti-depressant therapy in
MDD will include:
• Statistically significant improvements in mean MADRS total score for patients receiving adjunctive brexpiprazole compared with placebo. MADRS (Montgomery-Åsberg Depression Rating Scale) is a commonly used scale to assess the range of symptoms in patients with major depression
• A statistically significant advantage over placebo on all secondary endpoints
• Most common adverse events reported in the patients receiving adjunctive brexpiprazole were weight gain and akathisia (inner restlessness)
• Over 90% of patients completed the randomized phase of the trial
Additional information provided in the poster presentation at the EPA congress will be publicly disclosed at that time.
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Otsuka and Lundbeck are running an extensive development program for brexpiprazole. Three additional studies in depression and schizophrenia will conclude in the first half of 2014. Phase III clinical trials are also underway in patients with agitation associated with dementia of the Alzheimer's type, and adult patients with post-traumatic stress disorder.
About brexpiprazole (OPC-34712)Brexpiprazole is a novel investigational psychotherapeutic compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a so-called serotonin dopamine activity modulator (SDAM) acting as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at
5-HT2A and noradrenaline alpha1B receptors. It is hypothesized to provide improved efficacy and tolerability
over established adjunctive treatments for MDD.
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