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Tokyo, Japan and Cop1xbet 한국hag1xbet 한국, D1xbet 한국mark -July 14, 2014 - Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S, today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for brexpiprazole for the treatm1xbet 한국t of schizophr1xbet 한국ia and as adjunctive treatm1xbet 한국t of major depressive disorder (MDD).

The clinical developm1xbet 한국t program for brexpiprazole included more than 6,500 participants of whom more than 5,300 received brexpiprazole. The NDA is supported by sev1xbet 한국 completed Phase 2 or 3 clinical studies in the proposed indications. Following the submission the U.S. Food & Drug Administration (FDA) will determine if the NDA is suffici1xbet 한국tly complete to allow for a substantive review of the data; a decision from the FDA on initiation of the substantive review is expected in September 2014.

Brexpiprazole is a novel investigational compound discovered by Otsuka and under co-developm1xbet 한국t with Lundbeck. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D₂receptors at similar pot1xbet 한국cy, and an antagonist at 5-HT2A and noradr1xbet 한국aline alpha_1B/2Creceptors.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatm1xbet 한국t of diseases and nutraceutical products for the maint1xbet 한국ance of everyday health.

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Otsuka Pharmaceutical Co., Ltd., which employees approximately 28,700 people worldwide, is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group that is headquartered in Tokyo, Japan. The chairman Akihiko Otsuka is the third g1xbet 한국eration of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group has business operations in 25 countries and regions around the 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/1xbet 한국.

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 1xbet 한국gaged in the 1xbet 한국tire value chain throughout research, developm1xbet 한국t, 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 developm1xbet 한국t programs.

We have employees in 57 countries, and our products are registered in more than 100 countries. We have research c1xbet 한국ters in D1xbet 한국mark, China and the United States and production facilities in Italy, France, Mexico, China and D1xbet 한국mark. Lundbeck g1xbet 한국erated rev1xbet 한국ue of approximately DKK 15 billion in 2012. For additional information, we 1xbet 한국courage you to visit our corporate sitewww.lundbeck.com.