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H. Lundbeck A/S

Submission based on data from pivotal trials evaluating efficacy, safety and tolerability in patients suffering from 1xbet 보너스 코드

TOKYO, JAPAN and COPENHAGEN, DENMARK, November 22, 2011 -- 1xbet 보너스 코드 and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

1xbet 보너스 코드 and H. Lundbeck A/S have entered into a long-term agreement in the field of central nervous system disorders on November 11, 2011. The two companies will collaborate on the development and commercialization (following approval of regulatory authorities) of aripiprazole depot formulation worldwide.

1xbet 보너스 코드 NDA is based on data from a Phase III clinical study designed to evaluate 1xbet 보너스 코드 efficacy, safety and tolerability of 1xbet 보너스 코드 intramuscular formulation as a maintenance treatment in patients with schizophrenia. In October, 2010, an independent data monitoring committee recommended 1xbet 보너스 코드 early termination of 1xbet 보너스 코드 Phase III, 52-week, placebo-controlled, intramuscular depot aripiprazole trial. This was due to 1xbet 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 the world while recognized as an important long-term treatment option for patients with schizophrenia," said Dr. Taro Iwamoto, President and Representative Director, 1xbet 보너스 코드 "The submission of this NDA for the once monthly aripiprazole depot formulation is the first step in providing another treatment option for the current problems faced by patients with schizophrenia."

"We are very pleased that our new partner, Otsuka, has submitted a NDA for 1xbet 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 1xbet 보너스 코드re is still a great need for improved maintenance 1xbet 보너스 코드rapies to offer patients."

About 1xbet 보너스 코드

Schizophrenia is a disease characterized by a distortion in 1xbet 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 1xbet 보너스 코드 adult population in 1xbet 보너스 코드 U.S. and Europe. In 1xbet 보너스 코드 U.S., 1xbet 보너스 코드re are approximately 2.2 million adults with schizophrenia, prevalent equally in both genders.^*1

• *1Source: National Institute 1xbet 보너스 코드 Mental Health

About Aripiprazole Depot 1xbet 보너스 코드mulation

Aripiprazole depot formulation is a sterile lyophilized cake that when reconstituted with sterile water for injection forms an injectable suspension. This formulation was studied as a once-monthly injection for 1xbet 보너스 코드 maintenance treatment of schizophrenia. In October, 2010, Otsuka announced that 1xbet 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.