Otsuka and Lundbeck Initiate the Regulatory Process for Aripiprazole (Once-Monthly) Depot Formulation in Europe

  Otsuka and Lundbeck Initiate the Regulatory Process for Aripiprazole
  (Once-Monthly) Depot Formulation in Europe

  *Aripiprazole depot formulation is the first partial dopamine agonist in
    development for maintenance treatment of schizophrenia as extended-release
    injectable suspension
  *New data presented at the 51^st Annual Meeting of the American College of
    Neuropsychopharmacology (ACNP) support efficacy of aripiprazole depot
    formulation, thus further supporting the data package for the European

  *It is estimated that schizophrenia affects approximately 1% of the adult
    population in Europe and the U.S., and approximately 24 million people

Business Wire

TOKYO & COPENHAGEN, Denmark -- December 21, 2012

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today
announced the European Medicines Agency's (EMA) acceptance of the submission
of a marketing authorisation application (MAA) for the approval of
aripiprazole depot formulation. The application of aripiprazole depot
formulation is for the maintenance treatment of adult patients with

"Our efforts to bring the aripiprazole depot formulation to market demonstrate
our long-term commitment to discover, develop and champion treatments for the
most challenging psychiatric diseases," said William H. Carson, M.D.,
President and CEO, Otsuka Pharmaceutical Development & Commercialization, Inc.
"If approved, more patients with schizophrenia will have access to the
efficacy and safety profile of aripiprazole in a once-monthly formulation."

"Long-acting therapies are moving to the forefront of treatment for
psychiatric disorders, and I am very excited that we now also have submitted
this product in Europe," says Executive Vice President Anders Gersel Pedersen,
Head of Research & Development at Lundbeck, and continues: "If approved,
aripiprazole depot formulation will offer the clinical properties of oral
aripiprazole, including its safety and efficacy profile, in a form that is
suited to patients who may have difficulties consistently taking their

Aripiprazole depot formulation is the first dopamine D[2 ]partial agonist
submitted in Europe as a once-monthly injection. If approved, it will be a new
treatment option to address the need for relapse prevention in patients with
schizophrenia, a chronic and debilitating disease.

Results from the first clinical trial of aripiprazole depot formulation were
presented in four poster presentations at the 2012 American Psychiatric
Association (APA) Annual Meeting in May 2012 and have subsequently been
published in the Journal of Clinical Psychiatry (Kane et al J Clin Psych,
2012). In December 2012, data from the second pivotal trial were presented at
the 51^st Annual Meeting at the American College of Neuropsychopharmacology
(ACNP) in Hollywood, Florida.

On 11 November 2011, Otsuka and Lundbeck announced an alliance to collaborate
on the development and commercialisation of up to five early and late stage
compounds in development. The two companies will co-commercialise aripiprazole
depot formulation in the U.S. and will collaborate on the development and
commercialisation of aripiprazole depot formulation in other markets
worldwide. Aripiprazole depot formulation remains under review by the U.S.
Food and Drug Administration (FDA).

About schizophrenia and disease relapse

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. In the U.S., there are approximately 2.4 million adults
with schizophrenia, prevalent equally in both genders^3,4. While there is no
cure for the disease, symptoms and risk of relapse can be managed in most
patients with appropriate antipsychotic treatment. However, when the disease
is not managed, patients are at increased risk of disease relapse, which can
cause the re-emergence or worsening of psychotic symptoms.

Relapses can occur during the natural course of schizophrenia^5, but the major
driver of recurrent episodes is medication non-adherence^6,7, which may be as
high as 50%. 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.

Recurrent relapses can result in function decline that may never return to
pre-morbid levels^6,8,9. The goals of long-term therapy in schizophrenia are
therefor to prevent relapse, and to reduce the severity of side effects and
residual symptoms^10,11.

About aripiprazole depot formulation

Aripiprazole depot formulation for extended-release injectable suspension, an
intramuscular (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.

After an initial injection of aripiprazole depot formulation along with an
overlapping 14-day dosing of oral antipsychotic treatment, subsequent
injections of aripiprazole depot formulation provide uninterrupted medication
coverage for a month. Depot formulations of antipsychotic agents provide
patients with stable concentrations of active drug that remain at a
therapeutic range for an extended period of time and also allow psychiatrists
to know when a patient does not return for a scheduled injection^12,13.

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 consumer 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 24 countries and regions around the world, with
consolidated sales of approximately EUR 10.5 billion (JPY 1.15 trillion or USD
14.0 billion) for fiscal year 2011. For more information, visit

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is an international pharmaceutical
company highly committed to improving the quality of life for people suffering
from brain disorders. For this purpose, Lundbeck is engaged in the research,
development, production, marketing and sale of pharmaceuticals across the
world. The company's products are targeted at disorders such as depression and
anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and
Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today
Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with brain disorders. In
2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.1
billion or USD 3.0 billion). For more information, please visit

^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 Regier, Darrel et al. The de Facto US Mental and Addictive Disorder Service
System. Arch Gen Psychiatry. 1993; 50: 85-94.
^4 Topics-Statistics: Schizophrenia. 2010. Available at
Accessed July 18, 2012.
^5 Wiersma D, Wanderling J, Dragomirecka E, et al. Social disability in
schizophrenia: its development and prediction over 15 years in incidence
cohorts in six European centres. Psychol Med 2000; 30 (5): 1155–1167
^6 Ascher-Svanum H, Zhu B, Faries D, et al. A prospective study of risk
factors for nonadherence with antipsychotic medication in the treatment of
schizophrenia. J Clin Psychiatry 2006; 67 (7): 1114–1123
^7 Robinson D, Woerner MG, Alvir JM, et al. Predictors of relapse following
response from a first episode of schizophrenia or schizoaffective disorder.
Arch Gen Psychiatry 1999; 56 (3): 241–247
^8 Ayuso-Gutiérrez JL, del Río Vega. Factors influencing relapse in the
long-term course of schizophrenia. Schizophr Res 1997; 28: 199–206.
^9 Lieberman JA, Perkins D, Belger A, et al. The early stages of
schizophrenia: speculations on pathogenesis, pathophysiology, and therapeutic
approaches. Biol Psychiatry 2001; 50 (11): 884–897.
^10 Lehman AF, Lieberman JA, Dixon LB, et al; for the Work Group on
Schizophrenia. Practice guideline for the treatment of patients with
schizophrenia. 2^nd Edition. Arlington, VA: American Psychiatric Association;
2004. © American Psychiatric Association, 2010. Accessed at
May 2012.
^11 Falkai P, Wobrock T, Lieberman J, et al. World Federation of Societies of
Biological Psychiatry (WFSBP) guidelines for biological treatment of
schizophrenia, Part 2: Long-term treatment of schizophrenia. World J Biol
Psychiatry 2006; 7 (1): 5–40
^12 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.
^13 Kane, JM et al. "Guidelines for depot antipsychotic treatment in
schizophrenia." Eur Neuropsychopharmacol, 1998; 8(1): 55-66.

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