Otsuka and Lundbeck Receive Positive CHMP Opinion in Europe for Abilify MaintenaTM, a Once-Monthly Injectable for Schizophrenia

  Otsuka and Lundbeck Receive Positive CHMP Opinion in Europe for Abilify
  MaintenaTM, a Once-Monthly Injectable for Schizophrenia

  *If approved by the European Commission, Abilify Maintena^TM would become
    the only dopamine D2 partial agonist in once-monthly, injectable form for
    maintenance treatment of schizophrenia in adult patients stabilized with
    oral aripiprazole.
  *Reducing the risk of relapse is an important consideration inthe
    treatment of patients with schizophrenia. Clinical trials demonstrated
    that Abilify Maintena reduced the risk of relapse in adult patients with
    schizophrenia in comparison with placebo.
  *Approval of this new once-monthly formulation of aripiprazole in Europe
    will provide patients with schizophrenia with an effective and well
    tolerated alternative treatment option.

Business Wire

TOKYO & COPENHAGEN, Denmark -- September 20, 2013

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today
announced a positive opinion from the European Medicines Agency's Committee
for Medicinal Products for Human Use (CHMP) recommending marketing
authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot
formulation indicated for maintenance treatment of schizophrenia in adult
patients stabilized with oral aripiprazole.

The pharmacological properties of aripiprazole are mediated through a
combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors
and antagonism at serotonin 5-HT2A receptors. Abilify Maintena is a
once-monthly injectable form of aripiprazole that has already received
regulatory approval in the U.S. It represents an alternative treatment option
to address the ongoing need to reduce the risk of relapse (relative to
placebo) in patients with schizophrenia.

The benefits with Abilify Maintena are its ability to reduce the proportion of
stabilized patients experiencing relapse in long-term use and its properties
to act as long-acting agent, allowing a monthly administration instead of a
daily oral intake of aripiprazole. Patients are previously stabilized with
oral aripiprazole.

“I am delighted that we now have a positive opinion for Abilify Maintena from
the CHMP and if approved will be able to provide European patients with a
long-term maintenance option for schizophrenia,” said Ole Vahlgren, Chief
Executive Officer & President, Otsuka Europe.

“Abilify Maintena has now been available in the U.S. for some six months with
encouraging feedback from patients and physicians, and we now look forward to
launching this important treatment alternative together with our partner
Otsuka into the psychiatric community in Europe as well,” said Ole Chrintz,
Senior Vice President, International Markets & Europe, Lundbeck. He continued,
“Abilify Maintena represents an important treatment option for patients as
well as their physicians and caregivers seeking an alternative long-term
maintenance treatment for schizophrenia.”

The efficacy of Abilify Maintena was demonstrated in two double-blind,
randomized phase III trials over 38 and 52 weeks.

In the primary pivotal trial analysis of the primary efficacy endpoint, the
proportion of patients experiencing impending relapse by the end of week 26,
demonstrated non-inferiority of Abilify Maintena to oral aripiprazole and
superior to a sub-therapeutic dose of aripiprazole once monthly (Fleischhacker
et al, poster, APA 2013). The key secondary endpoint, time to relapse,
supported the efficacy in maintenance treatment.

In the second pivotal efficacy trial, Abilify Maintena significantly delayed
time to relapse compared with placebo (primary efficacy endpoint).^1 In a key
secondary endpoint, the percentage of subjects experiencing relapse was also
significantly lower with Abilify Maintena compared with placebo at the end of
the study.

The safety profile for Abilify Maintena was comparable to oral Abilify. The
most frequently observed adverse drug reactions (ADRs) reported in ≥ 5 % of
patients in two double-blind controlled clinical trials of Abilify Maintena
were weight increases (9.0%), akathisia (7.9%), insomnia (5.8%), and injection
site pain (5.1%).^1

On 11 November 2011, Otsuka and Lundbeck announced the formation of an
alliance to collaborate on the development and commercialization of up to five
early- and late-stage compounds in development. Abilify Maintena is expected
to be the first commercialized product in the EU from the global alliance
between the two companies focused on developing Central Nervous System (CNS)
therapies worldwide.

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 lifelong treatment to mitigate symptoms.

It has been estimated that schizophrenia affects approximately 1 percent of
the adult population in the U.S. and Europe, and approximately 24 million
people worldwide.^2,3 In the U.S., there are approximately 2.4 million adults
with schizophrenia, prevalent equally in both genders.^4,5 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.^6

Schizophrenia places a significant burden on society and is according to the
World Health Organization (WHO), the 8th leading cause of DALYs (lost healthy
years) worldwide between the age of 15-44^7 and is also regarded among the
most financially costly illnesses. With 50 percent of patients not receiving
appropriate care and 80 percent of patients relapsing within the first 5
years,^8 there is a significant unmet need to be addressed in schizophrenia.

Relapse of schizophrenia can occur when a patient no longer responds to
antipsychotic medication or stops taking their medication. There are many
reasons patients stop taking their medication, including poor patient insight
about their illness, side effects from his or her current treatment,
complicated medication regimens or lack of support from family.^9

About Abilify Maintena (aripiprazole)

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
maintenance treatment of schizophrenia in adult patients stabilized with oral
aripiprazole.

After an initial injection of Abilify Maintena along with a transitional
14-day dosing of oral aripiprazole treatment, subsequent injections of Abilify
Maintena provide uninterrupted medication coverage for 30 days at a time.

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 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 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 has business operations in 25 countries and
regions around the world, with consolidated sales of approximately USD13
billion or €10 billion for fiscal year 2012 (4/1/2012-3/31/2013.) Otsuka
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 programs.

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.

REFERENCES:

1. Kane, JM et al. “Aripiprazole Intramuscular Depot as Maintenance Treatment
in Patients With Schizophrenia: A 52-Week, Multicenter, Randomized,
Double-Blind, Placebo-Controlled Study.” J Clin Psychiatry 2012;73(5):617-62

2. National Institute of Mental Health (NIMH). Health Topics: Statistics.
Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed July
19, 2012

3. World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available
at: http://www.who.int/mental_health/management/schizophrenia/en/. Accessed
July 16. 2012.

4. Topics-Statistics: Schizophrenia. 2010. Available at
http://wwwapps.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america.shtml#RegierServiceSystem.
Accessed July 18, 2012.

5. Regier, Darrel et al. The de Facto US Mental and Addictive Disorder Service
System. Arch Gen Psychiatry. 1993; 50: 85-94

6. World Health Organisation (2001) The World Health Report, page 27, accessed
at http://www.who.int/whr/2001/en/whr01_en.pdf

7. World Health Organisation (2013) ‘Schizophrenia’, accessed at
http://www.who.int/mental_health/management/schizophrenia/en/.

8. Robinson D, et al. Arch Gen Psychiatry. 1999;56(3):241-247

9. Baloush-Kleinman V et al. Schizophr Res (2011), Beck EM et al. Schizophr
Res 2011, Birnbaum M, Sharif Z. Patient Prefer Adherence 2008, Misdrahi D et
al. Nord J Psychiatry 2012

Contact:

Otsuka Pharmaceutical Co., Ltd. Contacts
Media:
EUROPE
Otsuka Pharmaceutical Europe Ltd.
Alison Ross, +44 7768 337128
aross@otsuka-europe.com
or
JAPAN/ASIA
Otsuka Pharmaceutical Co., Ltd.
Jeffrey Gilbert, +81 3 6361 7379, +81 80 8728 6039 (cell)
gilbert.jeffrey@otsuka.co.jp
or
NORTH AMERICA
Otsuka America Pharmaceutical, Inc.
Rose Weldon, +1-609-524-6879, +1-215-801-7644 (cell)
rose.weldon@otsuka-us.com
or
H. Lundbeck A/S Contacts
Media:
U.S.
Lundbeck
Ashleigh Duchene, +1-847-282-1164
aduc@lundbeck.com
or
EUROPE
Lundbeck
Mads Kronborg, +45 36 43 28 51
mavk@lundbeck.com
or
Investors:
Lundbeck
Palle Holm Olesen, +45 36 43 24 26
Chief Specialist, Investor Relations
palo@lundbeck.com
 
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