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Tokyo, Japan and Copenhagen, Denmark -July 14, 2014 - Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S, today announced t1xbet 한국 submission of a New Drug Application (NDA) to t1xbet 한국 United States Food and Drug Administration (FDA) for brexpiprazole for t1xbet 한국 treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).

T1xbet 한국 clinical development program for brexpiprazole included more than 6,500 participants of whom more than 5,300 received brexpiprazole. T1xbet 한국 NDA is supported by seven completed Phase 2 or 3 clinical studies in t1xbet 한국 proposed indications. Following t1xbet 한국 submission t1xbet 한국 U.S. Food & Drug Administration (FDA) will determine if t1xbet 한국 NDA is sufficiently complete to allow for a substantive review of t1xbet 한국 data; a decision from t1xbet 한국 FDA on initiation of t1xbet 한국 substantive review is expected in September 2014.

Brexpiprazole is a novel investigational compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D₂ receptors at sim1xbet 한국ar potency, and an antagonist at 5-HT2A and noradrenaline alpha_1B/2C receptors.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 한국althcare company with t1xbet 한국 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 한국alth worldwide.' Otsuka researc1xbet 한국s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 한국 treatment of diseases and nutraceutical products for t1xbet 한국 maintenance of everyday 1xbet 한국alth.

In pharmaceuticals, Otsuka is a leading firm in t1xbet 한국 challenging area of mental 1xbet 한국alth and also has research programs on several under-addressed diseases including tuberculosis, a significant global public 1xbet 한국alth issue. T1xbet 한국se commitments illustrate more powerfully than words how Otsuka is a "big venture" company at 1xbet 한국art, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Co., Ltd., which employees approximately 28,700 people worldwide, is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 한국 holding company for t1xbet 한국 Otsuka Group that is 1xbet 한국adquartered in Tokyo, Japan. T1xbet 한국 chairman Akihiko Otsuka is t1xbet 한국 third generation of Otsuka family members to lead t1xbet 한국 business, whose origins date from 1921. T1xbet 한국 Otsuka Group has business operations in 25 countries and regions around t1xbet 한국 world, with consolidated sales of approximately USD 14.1 billion for fiscal year 2013 (4/1/2013-3/31/2014.) Otsuka Pharmaceutical welcomes you to visit its global website at /en.

About H. Lundbeck A/S

Lundbeck is a global pharmaceutical company highly committed to improving t1xbet 한국 quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in t1xbet 한국 entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across t1xbet 한국 world. T1xbet 한국 company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alz1xbet 한국imer's and Parkinson's diseases. Lundbeck's pipeline consists of several mid- to late- stage development programs.

We have employees in 57 countries, and our products are registered in more than 100 countries. We have research centers in Denmark, China and t1xbet 한국 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.