The Otsuka and Lundbeck Alliance Announces Once-Monthly (Pr)ABILIFY MAINTENA(TM) (ARIPIPRAZOLE for prolonged release injectable

The Otsuka and Lundbeck Alliance Announces Once-Monthly (Pr)ABILIFY 
MAINTENA(TM) (ARIPIPRAZOLE for prolonged release injectable suspension)1 Now 
Approved in Canada for the Maintenance Treatment of Schizophrenia in 
Stabilized Adult Patients 
TOKYO and MONTREAL, Feb. 12, 2014 /CNW/ - Otsuka Pharmaceutical Co., Ltd. 
(Otsuka) and H. Lundbeck A/S (Lundbeck) announce Health Canada's issuance of a 
Notice of Compliance for ABILIFY MAINTENA™, an intramuscular (IM) 
once-monthly injectable formulation indicated for the maintenance treatment of 
schizophrenia in stabilized adult patients.  ABILIFY MAINTENA(TM) will be the 
first commercialized product in Canada from the global alliance between Otsuka 
and Lundbeck, which is focused on developing Central Nervous System (CNS) 
therapies worldwide. The companies expect the product will be available in 
Canada in April 2014. 
ABILIFY MAINTENA(TM) is the only dopamine D2 partial agonist in once-monthly, 
injectable form to receive marketing authorization for maintenance treatment 
in schizophrenia. ABILIFY MAINTENA(TM) reduces the risk of relapse relative to 
placebo over the long-term and provides effective treatment of schizophrenia. 
In controlled clinical trials, ABILIFY MAINTENA(TM) was found to prevent 
relapse for up to 38 weeks after stabilization with oral aripiprazole and has 
a tolerability profile similar to oral aripiprazole.(2,3) 
Efficacy was demonstrated through two pivotal trials: a 38 week active 
controlled trial to examine the proportion of subjects meeting impending 
relapse criteria and a 52 week placebo controlled trial, which examined the 
time to impending relapse. In the latter study, time to impending relapse was 
significantly delayed with ABILIFY MAINTENA™ compared with IM placebo (p < 
0.0001; log rank test). 
About the Otsuka and Lundbeck Global Alliance
Otsuka and Lundbeck established a global alliance in November 2011 to bring to 
bear their considerable experience and resources in the CNS area to introduce 
next-generation treatments for conditions such as schizophrenia, depression, 
and Alzheimer's disease. 
About Otsuka 
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 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/. 
Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing health 
care company that commercializes Otsuka medicines in Canada, with a focus on 
commitment to neuroscience, cardiovascular, and oncology. OCPI is dedicated to 
improving patients' health and the quality of human life. OCPI is part of the 
Otsuka Group, and was established in 2010, with headquarters in Saint-Laurent, 
Quebec. 
About Lundbeck 
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company 
specialized in brain diseases. For more than 50 years, Lundbeck has been at 
the forefront of research within neuroscience. Lundbeck's development and 
distribution of pioneering treatments continues to make a difference to people 
living with brain diseases. The key areas of focus are alcohol dependence, 
Alzheimer's disease, depression/anxiety, epilepsy, Huntington's disease, 
Parkinson's disease, schizophrenia and stroke. 
Lundbeck has approximately 6,000 employees in 57 countries are engaged in the 
entire value chain throughout research, development, production, marketing and 
sales, and are committed to improving the quality of life of people living 
with brain diseases. The Lundbeck pipeline consists of several late-stage 
development programs and products are available in more 100 countries. 
Lundbeck has research centres in China, Denmark and the United States, and 
production facilities in China, Denmark, France, Italy and Mexico. Lundbeck 
generated revenue of approximately DKK 15 billion in 2013 (EUR 2.0 billion; 
USD 2.7 billion). 
A division of Denmark-based H. Lundbeck A/S, Lundbeck Canada Inc. has been a 
trusted source of innovative new treatments for Canadians since 1995 with 
headquarters in Montreal.  Originally focused on providing products for the 
treatment of diseases such as depression, anxiety, Alzheimer's disease and 
schizophrenia, Lundbeck Canada now offers new cancer therapies for the 
treatment of chronic lymphocytic leukemia and non-Hodgkin lymphoma.  A 
patient-focused partner in Canadian health care, Lundbeck Canada's mission is 
to improve the quality of life for people living with brain diseases and 
cancer. 
Abilify Maintena is a trademark of Otsuka Pharmaceutical Co., Ltd., used under 
licence by Otsuka Canada Pharmaceutical Inc. 
REFERENCES: 


      1. Abilify Maintena Product Monograph. Otsuka Pharmaceutical Co.
         Ltd., February 6, 2014.
      2. 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):617-624.
      3. Fleischhacker WW et al.  Aripiprazole once-monthly for the
         treatment of schizophrenia: a double-blind, randomized,
         non-inferiority study vs. oral aripiprazole. Annual Meeting of the
         American Psychiatric Association, 18-22 May, 2013 (poster);
         Fleischhacker et al. Aripiprazole once-monthly for treatment of
         schizophrenia: a double-blind, randomised, non-inferiority study.
         Submitted to The British Journal of Psychiatry.

© 2014  Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada Inc. All Rights 
Reserved.



SOURCE  Otsuka Pharmaceutical Co., Ltd. 
Media enquiries: 
Daphne Weatherby Weber Shandwick dweatherby@webershandwick.com (514) 
294-6279 
Dan McCarthy Lundbeck Canada DMY@lundbeck.com (514) 844-8515 
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CO: H. Lundbeck A/S
ST: Quebec
NI: MTC HEA VNT  
-0- Feb/13/2014 01:25 GMT
 
 
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