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February 13, 2014

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Otsuka and Lundbeck Announce Once-Monthly Abilify Maintena™ Approved in Canada for the Maintenance Treatment of Schizophrenia in Stabilized Adult Patients

Tokyo, Japan and Montreal, Canada - February 13, 2014 - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced 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 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 is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia. ABILIFY MAINTENA reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia. In controlled clinical trials, ABILIFY MAINTENA was shown to be significantly superior in comparison to non-active treatments (placebo or pseudo-placebo) in the prevention of psychotic symptoms/impending relapse for up to 38 weeks after stabilization with oral aripiprazole .*1, 2 Further, efficacy was found to be comparable to that of oral aripiprazole with a similar tolerability profile. *2 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).

  • *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):617-624.
  • *2 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.

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, Alzheimer's disease and alcohol dependency.

About Otsuka Canada Pharmaceutical Inc. (OCPI)

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 Technoparc Montreal, in Saint-Laurent, Quebec.

About Lundbeck Inc.

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 programmes.

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.


Information in this news release was current as of the original release date.

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