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January 24, 2014

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Otsuka and Lundbeck to present new data on brexpiprazole in major depressive disorder (MDD) at European Psychiatry Association 2014 Congress

(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.

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.

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.

About H. Lundbeck A/S

Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in the entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline consists of several mid- to late-stage development programmes.

Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in Denmark. We have research in 57 countries and our products are registered in more than 100 countries. We have research centers in Denmark, China and the United States and production facilities in Italy, France, Mexico, China and Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012. For additional information, we encourage you to visit our corporate site www.lundbeck.com.


Information in this news release was current as of the original release date.

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