|[July 14, 2014]
Otsuka and Lundbeck Submit New Drug Application in the US for Brexpiprazole for the Treatment of Schizophrenia and as Adjunctive Therapy for the Treatment of Major Depressive Disorder
TOKYO & COPENHAGEN, Denmark --(Business Wire)--
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 treatment of
schizophrenia and as adjunctive treatment of major depressive disorder
The clinical development program for brexpiprazole included more than
6,500 participants of whom more than 5,300 received brexpiprazole. The
NDA is supported by seven 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 sufficiently 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-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
similar potency, and an antagonist at 5-HT2A and
noradrenaline alpha1B/2C receptors.
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the
corporate philosophy: 'Otsuka-people creating new products for better
health worldwide.' Otuka researches, develops, manufactures and markets
innovative and original products, with a focus on pharmaceutical
products for the treatment of diseases and nutraceutical products for
the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leading firm in the challenging area of
mental health and also has research programs on several under-addressed
diseases including tuberculosis, a significant global public health
issue. These commitments illustrate more powerfully than words how
Otsuka is a "big venture" company at heart, applying a youthful spirit
of creativity in everything it does.
Otsuka Pharmaceutical Co., Ltd., which employs 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 generation 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 https://www.otsuka.co.jp/en.
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 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
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.
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