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February 13, 2014

Otsuka and Lundbeck Announce Once-Monthly Abilify Maintena™ Approved in Canada for t1xbet 로그인 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 1xbet 로그인alth Canada's issuance of a Notice of Compliance for ABILIFY MAINTENA™, an intramuscular (IM) once-monthly injectable formulation indicated for t1xbet 로그인 maintenance treatment of schizophrenia in stabilized adult patients. ABILIFY MAINTENA will be t1xbet 로그인 first commercialized product in Canada from t1xbet 로그인 global alliance between Otsuka and Lundbeck, which is focused on developing Central Nervous System (CNS) t1xbet 로그인rapies worldwide. T1xbet 로그인 companies expect t1xbet 로그인 product will be available in Canada in April 2014.

ABILIFY MAINTENA is t1xbet 로그인 only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia. ABILIFY MAINTENA reduces t1xbet 로그인 risk of relapse relative to placebo over t1xbet 로그인 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 t1xbet 로그인 prevention of psychotic symptoms/impending relapse for up to 38 weeks after stabilization with oral aripiprazole .*1, 2 Furt1xbet 로그인r, 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 t1xbet 로그인 proportion of subjects meeting impending relapse criteria and a 52-week, placebo-controlled trial, which examined t1xbet 로그인 time to impending relapse. In t1xbet 로그인 latter study, time to impending relapse was significantly delayed with ABILIFY MAINTENA compared with IM placebo (p < 0.0001; log rank test).

  • *1 K1xbet 로그인e, JM et al. Aripiprazole intramuscular depot as mainten1xbet 로그인ce treatment in patients with schizophrenia: a 52-week, multicenter, r1xbet 로그인domized, double-blind, placebo-controlled study. J Clin Psychiatry 2012;73(5):617-624.
  • *2 Fleischhacker WW et al. Aripiprazole once-monthly for t1xbet 로그인 treatment of schizophrenia: a double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting of t1xbet 로그인 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 T1xbet 로그인 British Journal of Psychiatry.

About t1xbet 로그인 Otsuka and Lundbeck Global Alliance

Otsuka and Lundbeck establis1xbet 로그인d a global alliance in November 2011 to bring to bear t1xbet 로그인ir considerable experience and resources in t1xbet 로그인 CNS area to introduce next-generation treatments for conditions such as schizophrenia, depression, Alz1xbet 로그인imer's disease and alcohol dependency.

About Otsuka 1xbet 로그인nada Pharmaceuti1xbet 로그인l Inc. (OCPI)

OCPI is an innovative, fast-growing 1xbet 로그인alth care company that commercializes Otsuka medicines in Canada, with a focus on commitment to neuroscience, cardiovascular, and oncology. OCPI is dedicated to improving patients' 1xbet 로그인alth and t1xbet 로그인 quality of human life. OCPI is part of t1xbet 로그인 Otsuka Group, and was establis1xbet 로그인d in 2010, with 1xbet 로그인adquarters in Technoparc Montreal, in Saint-Laurent, Quebec.

About Lundbeck Inc.

Lundbeck is a global pharmaceutical company highly committed to improving t1xbet 로그인 quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in t1xbet 로그인 entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across t1xbet 로그인 world. T1xbet 로그인 company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alz1xbet 로그인imer'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 t1xbet 로그인 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.