H. Lundbeck A/S

Valby, 2013-03-07 07:00 CET (GLOBE NEWSWIRE) --
  -- Otsuka and Lundbeck expand their existing collaboration to include
     promotion of Abilify swallowable tablets, oral solution,
     orally-disintegrating tablets and the intramuscular rapid injectable in 14
     European countries.
  -- 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.  The drug was approved for use in schizophrenia by the U.S. FDA (Food
     and Drug Administration) on February 28.  Abilify Maintena will provide a
     new treatment option for patients with schizophrenia and their physicians.
  -- Abilify became the number one selling pharmaceutical product in the U.S. in
     the fourth quarter of 2012.



(Tokyo, Japan and Copenhagen, Denmark) 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 an agreement to expand their existing collaboration to
include promotion of 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-disintegrated tablet and the intramuscular rapid injectable. 

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical
Co., Ltd. emphasized that “the agreement will further strengthen the Abilify
brand in Europe and also position Otsuka and Lundbeck to successfully develop
and launch up to 5 more new products there.” 

The companies also 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. 
Abilify Maintena was approved by the U.S. Food and Drug Administration (FDA) on
February 28 for the treatment of schizophrenia. 

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.” 

Specific financial terms of the agreement remain undisclosed.

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. 



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. 



About Abilify Maintena and Abilify

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
medications5. In the fourth quarter of 2012 Abilify became the number 1 selling
pharmaceutical product in the U.S6. 



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 environment. 

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 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. 

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. 

___________________________________________________



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

2. World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available
at http://www.who.int/mental_health/management/schizophrenia/en/.  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
Anti-Psychotics 

6. IMS



Otsuka Pharmaceutical Co., Ltd. media contacts



North America                                                              
Japan/Asia: 

Rose Weldon                                                               
Jeffrey Gilbert 

Otsuka America Pharmaceutical, Inc.                              Otsuka
Pharmaceutical Co., Ltd. 

rose.weldon@otsuka-us.com                                        
gilbert.jeffrey@otsuka.jp 

+1 609 524 6879,                                                           +81
3 6361 7379, 

+1 215 801 7644 (cell)                                                    +81
80 8728 6039 (cell) 



Europe:
Alison Ross

Otsuka Pharmaceutical Europe Ltd.

+44 (0) 1895 207122

+44 (0) 7768 337128



H. Lundbeck A/S media contacts

U.S.                                                                  Europe:

Ashleigh Duchene                                             Mads Kronborg
Lundbeck                                                          Media
Relations, Lundbeck 

aduc@lundbeck.com                                         mavk@lundbeck.com

+1 847 282 1164                                                +45 36 43 28 51