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The Otsuka Pharmaceutical Co., Ltd. And H. Lundbeck A/S (LUN.CO) Alliance Announces Once-Monthly (Pr)ABILIFY MAINTENA(™) (ARIPIPRAZOLE For Prolonged Release Injectable Suspension)1 Now Approved In Canada For The Maintenance Treatment Of Schizophrenia In Stabilized Adult Patients


2/13/2014 7:13:21 AM

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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 MAINTENATM 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 MAINTENATM is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia. ABILIFY MAINTENATM reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia. In controlled clinical trials, ABILIFY MAINTENATM 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

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:

Abilify Maintena Product Monograph. Otsuka Pharmaceutical Co. Ltd., February 6, 2014 .
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.
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.

Image with caption: "Otsuka and Lundbeck Global Alliance (CNW Group/Otsuka Pharmaceutical Co., Ltd.)". Image available at: http://photos.newswire.ca/images/download/20140212_C9848_PHOTO_EN_36665.jpg

Contact:

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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