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Otsuka Pharmaceutical Co., Ltd. Release: New Once-Monthly Treatment For Schizophrenia, ABILIFY MAINTENA™ (Aripiprazole For Prolonged Release Injectable Suspension), Now Available In Canada


5/5/2014 8:43:26 AM

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MONTREAL
, May 5, 2014 /CNW/ - Canadians living with schizophrenia now have a new option to help treat their disease. Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada Inc. announce today that ABILIFY MAINTENA (aripiprazole for prolonged release injectable suspension), indicated for the maintenance treatment of schizophrenia in stabilized adult patients, is now commercially available for use in Canada. ABILIFY MAINTENATM is the first product in Canada from the global alliance between Otsuka and Lundbeck, which is focused on developing Central Nervous System (CNS) therapies worldwide.

"Schizophrenia has a significant impact on an individual's quality of life, affecting their relationships with loved ones, their ability to function in multiple domains such as school, career and hobbies. Medication is key to effective treatment and staying on it can help reduce relapses to maintain a manageable quality of life," says Dr. Ruth Baruch, Medical Director of Community Service, Toronto East General Hospital. "With a new once-monthly treatment option like ABILIFY MAINTENATM, there is a chance for improved adherence which can help reduce relapses and enable those living with schizophrenia to live a better life, and offer hope for the future."

Schizophrenia is a serious mental illness that interferes with a person's ability to think clearly, manage emotions, make decisions and relate to others.1 Due to the chronic nature of schizophrenia, family caregivers play a vital role in supporting their loved ones that are afflicted with the illness, often taking on extra cost and burden themselves. It is estimated that some 70 per cent of persons with schizophrenia live with their parents.2

Hope for an Improved Quality of Life

The quality of life of family caregivers is closely tied to the health and well-being of their loved one living with schizophrenia. When their loved one is unwell, the family struggles along with them. Knowing that their loved one is safe, physically and mentally well, receiving appropriate treatment and social support is vital.3

"Medication is often key to managing relapses for the families we support. As intermediaries between families caring for loved ones living with schizophrenia and the government, it is critical that we work closely together to ensure that all treatments are accessible to all those who want to try new options," says Chris Summerville, Chief Executive Officer of the Schizophrenia Society of Canada.

Kerry's son was diagnosed with schizophrenia seven years ago. She has been his sole caregiver since his diagnosis, visiting him every day to ensure he is taking his medication, taking him grocery shopping and accompanying him to doctor's appointments. After visits to many different doctors, months of hospitalizations, and trying different treatments with unwelcome side effects, her son was enrolled in a clinical trial for once-monthly ABILIFY MAINTENATM.

"When my son had the chance to try ABILIFY MAINTENATM through a clinical trial in our area, our whole lives changed. I no longer had to babysit my adult son. The once-monthly injections gave me the peace of mind that he had medication to help keep his disease under control. Within a very short time he was back to himself. I was so relieved to not only have a bit of freedom, but also that the threat of a relapse was no longer a reality," says Kerry. "We have tried many different medications but they were never as effective as we would hope, some with horrible side effects. Now with ABILIFY MAINTENATM, he is a thousand per cent better. We were lucky to have found something that helped him, and maybe now it can help others too."

In Canada, schizophrenia affects about 300,000 people,4 or approximately one per cent of our population.5 Schizophrenia affects men and women with equal frequency.6 The illness most often appears in men in their late teens or early twenties, and most often appears in women in their late twenties or early thirties.7

About ABILIFY MAINTENATM

ABILIFY MAINTENATM (aripiprazole for prolonged release injectable suspension) is indicated for the maintenance treatment of schizophrenia in stabilized adult patients. 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.8,9

Efficacy was demonstrated through two pivotal trials: a 38-week double-blind randomized non-inferiority trial to examine the proportion of subjects meeting impending relapse criteria compared to oral aripiprazole, and a 52-week placebo-controlled trial, which examined the time to impending relapse. The latter study was terminated early after demonstrating that time to impending relapse was significantly delayed with ABILIFY MAINTENA compared with placebo injection (p < 0.0001; log rank test) at the pre-planned interim analysis.

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 who 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 than 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.

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

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1 Learn More About Schizophrenia: What Is Schizophrenia? [Internet]. Winnipeg: Schizophrenia Society of Canada; 2011. [cited November 28, 2013]. Available from: http://www.schizophrenia.ca/learn_more_about_schizophrenia.php#5

2 Summerville, C. & Atherley, G. Voice is the expression of opinion, judgment, will, or wish of the people or a number of persons. A Discussion. [Internet]. Winnipeg: Schizophrenia Society of Canada;2012;page 7. [cited 2013 November 2013]. Available from: http://www.schizophrenia.ca/articles.php

3 Martin, N.M. Quality of Life: As Defined By People Living With Schizophrenia And Their Families. [Internet]. Winnipeg: Schizophrenia Society of Canada; 2009;page 26. [cited 2013 November 2013]. Available from:
http://www.schizophrenia.ca/docs/FINALSSCQOLReport.pdf

4 Learn More About Schizophrenia: What Is Schizophrenia? [Internet]. Winnipeg: Schizophrenia Society of Canada; 2011. [cited 2013 November 2013]. Available from: http://www.schizophrenia.ca/learn_more_about_schizophrenia.php#5

5 Hafner H, an der Heiden W. Epidemiology of schizophrenia. Can J Psychiatry. 1997;42:139-51.

6 Learn More About Schizophrenia: What Is Schizophrenia? [Internet]. Winnipeg: Schizophrenia Society of Canada; 2011. [cited November 28, 2013]. Available from: http://www.schizophrenia.ca/learn_more_about_schizophrenia.php#5

7 Learn More About Schizophrenia: What Is Schizophrenia? [Internet]. Winnipeg: Schizophrenia Society of Canada; 2011. [cited November 28, 2013]. Available from: http://www.schizophrenia.ca/learn_more_about_schizophrenia.php#5

8 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.

9 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.



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/20140505_C6549_PHOTO_EN_39942.jpg



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