Otsuka Advancing Rapidly in Central Nervous System Disorders; Expanding Existing Collaboration with Lundbeck

  Otsuka Advancing Rapidly in Central Nervous System Disorders; Expanding
  Existing Collaboration with Lundbeck

  *ABILIFY^® became the #1 selling pharmaceutical product in the U.S. in the
    fourth quarter of 2012.
  *ABILIFY MAINTENA^™, a once-monthly injectable form of ABILIFY, will be
    co-promoted by Otsuka and Lundbeck in the U.S. and will start becoming
    available there from March 18^th. The drug was approved for use in
    schizophrenia by the U.S. FDA (Food and Drug Administration) on February
    28^th. ABILIFY MAINTENA will provide a new treatment option for patients
    with schizophrenia and their physicians.
  *Otsuka and Lundbeck are expanding their existing collaboration to include
    promotion of ABILIFY^® swallowable tablets, oral solution,
    orally-disintegrating tablets and the intramuscular rapid injectable in 14
    European countries.

Business Wire

TOKYO & COPENHAGEN, Denmark -- March 7, 2013

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today
outlined co-promotion plans and summarized the overall progress in their
global alliance at a session in Japan with representatives from domestic and
international media organizations.

The companies announced that ABILIFY MAINTENA™ (aripiprazole), an
extended-release (once-monthly) injectable suspension for the treatment of
schizophrenia will start becoming available in the U.S. market on March 18.
ABILFY MAINTENA was approved by the U.S. Food and Drug Administration (FDA) on
February 28 for the treatment of schizophrenia.

ABILIFY MAINTENA and ABILIFY^® contain the molecule aripiprazole, which is a
partial agonist at the D2 dopamine receptor and which offers a unique
mechanism of action for the treatment of schizophrenia. ABILIFY MAINTENA has
been shown in clinical studies to reduce relapses in schizophrenia in
comparison to placebo and will offer the efficacy and safety profile of the
oral formulations of ABILIFY in a once-monthly formulation.

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical
Co., Ltd. emphasized that "the MAINTENA launch will further strengthen the
ABILIFY brand's already-prominent position in the U.S. market and bodes well
for the two companies' ongoing collaborations."

Commenting on the first regulatory approval for the alliance, Ulf Wiinberg,
Chief Executive Officer, Lundbeck said, "ABILIFY MAINTENA represents a
treatment option for patients and their physicians and caregivers seeking an
alternative long-term maintenance treatment for schizophrenia, and we are
pleased to join Otsuka in launching this first product as part of our
extensive global alliance. The launch of ABILIFY MAINTENA also represents
Lundbeck's first entry into the U.S. psychiatry market, expanding our central
nervous system focus strategically in the U.S."

The companies also announced an agreement to expand their existing
collaboration to include promotion of oral ABILIFY ^ in 14 European countries
starting April 1, 2013. Under the agreement, Otsuka and Lundbeck will jointly
promote ABILIFY in Denmark, Finland, Germany, Italy, Spain, Sweden and the
United Kingdom. Lundbeck will promote ABILIFY in Austria, Belgium, Ireland,
Netherlands, Poland, Portugal and Romania.

The agreement provides Lundbeck with the rights to promote all formulations of
ABILIFY that are currently being marketed, sold and distributed by Otsuka in
the European Union including the swallowable tablet, oral solution,
orally-disintegrating tablet and the IM rapid injectable. Lundbeck will
promote ABILIFY Tablets in first position to target physicians.

Summary of Overall Progress in the Global Alliance Between Otsuka and Lundbeck

While some other companies have exited the central nervous system therapy
area, Otsuka and Lundbeck are investing to develop potential future drugs to
help patients, such as brexpiprazole, which is currently in phase III clinical
trials for multiple psychiatric disorders, and three other compounds yet to be
determined. An agreement to work in this under-served therapy area was signed
between the two companies in November, 2011. A successful first 17 months for
the alliance includes the following developments:

  *FDA approval of ABILIFY MAINTENA on February 28, 2013.
  *Marketing Authorization Application (MAA) for ABILIFY MAINTENA submitted
    in Europe in December, 2012.
  *Expansion of the alliance by the signing of an agreement for promotion of
    ABILIFY products in Europe.
  *Phase-III studies initiated with brexpiprazole.
  *Two phase-III studies with ABILIFY MAINTENA initiated.
  *Results from phase-III trials with ABILIFY MAINTENA presented in May, 2012
    at the American Psychiatric Association (APA) 2012 Annual Meeting.

About Schizophrenia

Schizophrenia is a disease characterized by a distortion in the process of
thinking and of emotional responsiveness. It most commonly manifests as
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 the
condition is chronic, often requiring life-long treatment to mitigate
symptoms. It has been estimated that schizophrenia affects approximately 1% of
the adult population in the U.S. and Europe, and approximately 24 million
people worldwide.^1,2

Relapse of schizophrenia can occur when a patient no longer responds to
antipsychotic medication or when patients stop taking their medication. There
are many reasons patients stop taking their medication and they include: poor
insight about their illness, side effects from their current treatment,
complicated medication regimens or lack of support from their family.


ABILIFY MAINTENA for extended-release injectable suspension, an IM depot
formulation of aripiprazole, is a sterile lyophilized powder that, when
reconstituted with sterile water for injection, forms an injectable suspension
that can be administered monthly. ABILIFY MAINTENA is indicated for the
treatment of schizophrenia.

After an initial injection of ABILIFY MAINTENA along with an overlapping
14-day dosing of oral antipsychotic treatment, subsequent injections of
ABILIFY MAINTENA provide uninterrupted medication coverage for 30 days at a
time. Depot formulations of antipsychotic agents provide patients with
concentrations of active drug that remain at a therapeutic range for an
extended period of time.^3,4

The ABILIFY MAINTENA launch will further leverage the success of ABILIFY. As a
result of a significant, multi-year development effort, 14 New Drug
Applications (NDA) and Supplemental New Drug Applications (sNDA) have been
approved in the U.S. market for new uses and formulations supporting ABILIFY
since the product was introduced in 2002. Over this period, ABILIFY has been
used by more than 6 million patients. In 2012, ABILIFY was ranked number one
among antipsychotic drugs in a Harris Poll Physician Pulse survey that
measured five key attributes to gauge U.S. physicians' trust in leading
antipsychotic medications^5. In the fourth quarter of 2012 ABILIFY became the
#1 selling pharmaceutical product in the U.S^6.

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, 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. Otsuka is committed to being a corporation
that creates global value, adhering to the high ethical standards required of
a company involved in human health and life, maintaining a dynamic corporate
culture, and working in harmony with local communities and the natural

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka
Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group
has business operations in 25 countries and regions around the world, with
consolidated sales of approximately USD 14.7 billion for fiscal year 2011
(4/1/2011-3/31/2012.) We welcome you to visit our global websiteat

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 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

1. National Institute of Mental Health (NIMH). Health Topics: Statistics.
Available at Accessed July
19, 2012.
2. World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available
at Accessed
July 16, 2012.
3. Patel MX, David AS. "Why aren't depot antipsychotics prescribed more often
and what can be done about it?" Adv Psychiatr Treat, 2005; 11: 203-213.
4. Kane, JM et al. "Guidelines for depot antipsychotic treatment in
schizophrenia." Eur.Neuropsychopharmacol, 1998; 8(1): 55-66.
5. Harris Poll 2012 Physician Pulse Ranking of U.S. Physician Trust in
6. IMS

Photos/Multimedia Gallery Available:



Otsuka Pharmaceutical Co., Ltd. Contacts
North America
Otsuka America Pharmaceutical, Inc.
Rose Weldon, +1-609-524-6879, +1-215-801-7644 (cell)
Otsuka Pharmaceutical Co., Ltd.
Jeffrey Gilbert, +81-3-6361-7379, +81-80-8728-6039 (cell)
Otsuka Pharmaceutical Europe Ltd.
Alison Ross, +44-(0)-1895-207122, +44-(0)-7768-337128
H. Lundbeck A/S Contacts
Ashleigh Duchene, +1-847-282-1164
Mads Kronborg, +45-36-43-28-51
Press spacebar to pause and continue. Press esc to stop.