Otsuka and Lundbeck to Present New Data on Brexpiprazole in Major Depressive Disorder (MDD) at European Psychiatry Association

  Otsuka and Lundbeck to Present New Data on Brexpiprazole in Major Depressive
  Disorder (MDD) at European Psychiatry Association 2014 Congress

Business Wire

TOKYO & COPENHAGEN, Denmark -- January 24, 2014

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today
announced that the first phase III data on their investigational compound
brexpiprazole will be presented in an upcoming poster session at the 22^nd
European Psychiatry Association Congress (EPA) on March 2, 2014.

Data will be presented from a completed phase III, randomized,
placebo-controlled study investigating the effect of brexpiprazole as
adjunctive therapy to antidepressant therapy in patients with major depressive
disorder (MDD). Overall, brexpiprazole demonstrated efficacy and was well
tolerated as an adjunctive treatment for MDD patients with an inadequate
response to antidepressant treatment.

At the EPA congress, highlighted data on brexpiprazole as adjunctive therapy
to anti-depressant therapy in MDD will include:

  *Statistically significant improvements in mean MADRS total score for
    patients receiving adjunctive brexpiprazole compared with placebo. MADRS
    (Montgomery–Åsberg Depression Rating Scale) is a commonly used scale to
    assess the range of symptoms in patients with major depression
  *A statistically significant advantage over placebo on all secondary
    endpoints
  *Most common adverse events reported in the patients receiving adjunctive
    brexpiprazole were weight gain and akathisia (inner restlessness)
  *Over 90% of patients completed the randomized phase of the trial

Additional information provided in the poster presentation at the EPA congress
will be publicly disclosed at that time.

Otsuka and Lundbeck are running an extensive development program for
brexpiprazole. Three additional studies in depression and schizophrenia will
conclude in the first half of 2014. Phase III clinical trials are also
underway in patients with agitation associated with dementia of the
Alzheimer’s type.

About brexpiprazole (OPC-34712)
Brexpiprazole is a novel investigational psychotherapeutic compound discovered
by Otsuka and under co-development with Lundbeck. Brexpiprazole is a so-called
serotonin dopamine activity modulator (SDAM) acting as a partial agonist at
5-HT[1A] and dopamine D[2] receptors at similar potency, and an antagonist at
5-HT[2A] and noradrenaline alpha[1B] receptors. It is hypothesized to provide
improved efficacy and tolerability over established adjunctive treatments for
MDD.

About 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.' Otsuka 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 for 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 is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding
company for the Otsuka Group. The chairman Akihiko Otsuka is the third
generation of Otsuka family members to lead the business, whose origins date
from 1921. The Otsuka Group employs approximately 42,000 people globally and
its products are available in more than 80 countries worldwide. Consolidated
sales were approximately €10 billion or USD 13 billion for fiscal year 2012
(4/1/2012-3/31/2013). Otsuka Pharmaceutical welcomes you to visit its global
website at https://www.otsuka.co.jp/en/

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 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 programmes.

Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in
Denmark. We have research 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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Contact:

H. Lundbeck A/S Contacts
Investors:
Palle Holm Olesen, +45 36 43 24 26
Chief Specialist, Head of Investor Relations
palo@lundbeck.com
Media:
Mads Kronborg, +45 36 43 30 30
Media Relations Manager
mavk@lundbeck.com
or
Otsuka Contacts
Investors
Otsuka Holdings Co., Ltd.
Takuma Kimura, +81 3 6361 7411
Kimurata@Otsuka.jp
Media:
Otsuka Pharmaceutical Co, Ltd.
Jeffrey Gilbert, +81 3 6361 7379 / +81 80 8728 6039
gilbert.jeffrey@otsuka.co.jp
 
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