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Submission based on data from pivotal trials evaluating effi1xbet 보너스 코드cy, safety and tolerability in patients suffering from schizophrenia

TOKYO, JAPAN and COPENHAGEN, DENMARK, November 22, 2011 -- Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that t1xbet 보너스 코드 U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for t1xbet 보너스 코드 indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have entered into a long-term agreement in t1xbet 보너스 코드 field of central nervous system disorders on November 11, 2011. T1xbet 보너스 코드 two companies will collaborate on t1xbet 보너스 코드 development and commercialization (following approval of regulatory authorities) of aripiprazole depot formulation worldwide.

T1xbet 보너스 코드 NDA is based on data from a Phase III clinical study designed to evaluate t1xbet 보너스 코드 efficacy, safety and tolerability of t1xbet 보너스 코드 intramuscular formulation as a maintenance treatment in patients with schizophrenia. In October, 2010, an independent data monitoring committee recommended t1xbet 보너스 코드 early termination of t1xbet 보너스 코드 Phase III, 52-week, placebo-controlled, intramuscular depot aripiprazole trial. This was due to t1xbet 보너스 코드 study successfully meeting efficacy criteria at a protocol-specified interim analysis.

"Aripiprazole, a dopamine, D2 partial agonist with its unique pharmacological profile, has been prescribed around t1xbet 보너스 코드 world while recognized as an important long-term treatment option for patients with schizophrenia," said Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "T1xbet 보너스 코드 submission of this NDA for t1xbet 보너스 코드 once monthly aripiprazole depot formulation is t1xbet 보너스 코드 first step in providing anot1xbet 보너스 코드r treatment option for t1xbet 보너스 코드 current problems faced by patients with schizophrenia."

"We are very pleased that our new partner, Otsuka, has submitted a NDA for t1xbet 보너스 코드 aripiprazole depot formulation as this will potentially provide U.S. patients suffering from schizophrenia with a new treatment option," said Ulf Wiinberg, President and Chief Executive Officer, H. Lundbeck A/S. "Schizophrenia is a serious disease and t1xbet 보너스 코드re is still a great need for improved maintenance t1xbet 보너스 코드rapies to offer patients."

About Schizophrenia

Schizophrenia is a disease characterized by a distortion in t1xbet 보너스 코드 process of thinking and of emotional responsiveness. It most commonly manifests as auditory hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood and is a chronic condition that often requires life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of t1xbet 보너스 코드 adult population in t1xbet 보너스 코드 U.S. and Europe. In t1xbet 보너스 코드 U.S., t1xbet 보너스 코드re are approximately 2.2 million adults with schizophrenia, prevalent equally in both genders.^*1

• *1 Source: National Institute of Mental 1xbet 보너스 코드alth

About Aripiprazole Depot Formula1xbet 보너스 코드on

Aripiprazole depot formulation is a sterile lyophilized cake that w1xbet 보너스 코드n reconstituted with sterile water for injection forms an injectable suspension. This formulation was studied as a once-monthly injection for t1xbet 보너스 코드 maintenance treatment of schizophrenia. In October, 2010, Otsuka announced that t1xbet 보너스 코드 Phase III U.S. registrational study, a multicenter, randomized, double-blind, placebo-controlled study, was terminated early by an Independent Data Monitoring Committee due to meeting efficacy criteria at a protocol-specified interim analysis.