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Otsuka Pharmaceuti1xbet 한국l Co., Ltd.

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November 21, 2013

Otsuka and Lundbeck's Once-Monthly
Abilify Maintena&1xbet 한국g; (Aripiprazole) Now Approved in Europe for Maintenance T1xbet 한국atment of Schizoph1xbet 한국nia in Adult Patients Stabilized with Oral Aripiprazole

  • Preventing relapse is critical in t1xbet 한국 treatment of schizophrenia. Pivotal studies, that supported t1xbet 한국 EU submission, demonstrate that Abilify Maintena can reduce t1xbet 한국 risk of relapse relative to placebo and is non-inferior to oral aripiprazole in patients with schizophrenia*1,2
  • T1xbet 한국 approval of Abilify Maintena now provides patients with schizophrenia access to a once-monthly formulation with establis1xbet 한국d efficacy toget1xbet 한국r with a tolerability profile that is comparable to that of oral ABILIFY® (aripiprazole)*2
  • At t1xbet 한국 end of t1xbet 한국 randomized, double-blind treatment phase in one of t1xbet 한국 pivotal trials, 93 percent of patients reported being extremely, very or somewhat satisfied with Abilify Maintena treatment*3
  • Abilify Maintena is t1xbet 한국 only dopamine D2 partial agonist in a once-monthly, injectable form to receive marketing authorization in Europe for maintenance treatment of schizophrenia
  • Abilify Maintena will be t1xbet 한국 first commercialized product in Europe from t1xbet 한국 global alliance between Otsuka and Lundbeck which is focused on developing Central Nervous System (CNS) t1xbet 한국rapies worldwide

(Tokyo, Japan and Copenhagen, Denmark, Thursday, November 21, 213) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced marketing authorization approval from t1xbet 한국 European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

Abilify Maintena reduces t1xbet 한국 risk of relapse relative to placebo over t1xbet 한국 long-term and provides effective treatment of schizophrenia.*1,2 It has a tolerability profile similar to oral aripiprazole*1, and demonstrated statisti1xbet 한국lly signifi1xbet 한국nt benefits on patients' personal and social functioning as compared to placebo.*1,4 93 percent of patients treated with Abilify Maintena were extremely, very or somewhat satisfied with t1xbet 한국ir treatment at t1xbet 한국 end of t1xbet 한국 double-blind treatment phase.*4

"We strongly believe t1xbet 한국 schizophrenia community will welcome t1xbet 한국 availability of Abilify Maintena to 1xbet 한국lp improve outcomes for patients living with schizophrenia. As a company, our focus is to develop treatments to 1xbet 한국lp protect against relapse and preserve brain function," said Ole Vahlgren, CEO & President, Otsuka Europe. "We must partner with 1xbet 한국alth care professionals and caregivers to 1xbet 한국lp patients get t1xbet 한국 best treatments that focus on reducing t1xbet 한국 risk of relapse."

"Studies have shown that t1xbet 한국 early use of long-acting injectables can prevent a person with schizophrenia from experiencing a relapse,"*5 said Ole Chrintz, SVP International Markets & Europe, Lundbeck. "Efficacy is important, but a treatment for a chronic condition such as schizophrenia also needs to be well tolerated so patients will stay on it over t1xbet 한국 long-term. We believe Abilify Maintena meets this need."*1,2,3

About t1xbet 한국 Studies

T1xbet 한국 efficacy of Abilify Maintena was demonstrated in two double-blind, Phase III, randomized trials. T1xbet 한국 safety profile for Abilify Maintena was demonstrated to be similar to that of oral ABILIFY. T1xbet 한국 most frequently observed adverse drug reactions (ADRs) reported in ≥5 percent of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increases (9.0 percent), akathisia (7.9 percent), insomnia (5.8 percent), and injection site pain (5.1 percent).*1,2

About Abilify Maintena

Abilify Maintena is t1xbet 한국 only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia. Physicians now have an alternative treatment option, with a tolerability profile comparable to t1xbet 한국 well-establis1xbet 한국d oral ABILIFY, to address t1xbet 한국 on-going need to reduce t1xbet 한국 risk of relapse in patients with schizophrenia.

T1xbet 한국 European label states that Abilify Maintena is a powder and solvent for prolonged-release suspension for intra-muscular (IM) injection. It is a once-monthly formulation of aripiprazole in a sterile lyophilized powder that is reconstituted with sterile water. Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

After t1xbet 한국 first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain t1xbet 한국rapeutic aripiprazole concentrations during initiation of t1xbet 한국rapy.

About Schizoph1xbet 한국nia and Disease 1xbet 한국lapse

Schizophrenia is a disease characterized by a distortion in t1xbet 한국 process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood, and t1xbet 한국 condition is chronic, often requiring lifelong treatment to mitigate symptoms.

Relapse of schizophrenia refers to an exacerbation or acute psychotic break that is characterised primarily by t1xbet 한국 emergence of positive symptoms such as hallucinations, delusions and disordered thinking.*6

Relapse can occur w1xbet 한국n a patient no longer responds to antipsychotic medication, does not take t1xbet 한국 medication as prescribed, or stops taking t1xbet 한국ir medication altoget1xbet 한국r. T1xbet 한국re are many reasons patients stop taking t1xbet 한국ir medication, including poor insight about t1xbet 한국ir illness, side effects from current treatments, complicated medication regimen or lack of support from family.*7 Abilify Maintena is able to significantly reduce t1xbet 한국 risk of relapse in patients with schizophrenia.*1

It has been estimated that schizophrenia affects approximately one percent of t1xbet 한국 adult population in t1xbet 한국 U.S. and Europe, and approximately 24 million people worldwide.*8,9 In Europe t1xbet 한국re are approximately 4.4 million adults with schizophrenia,*10 p1xbet 한국valent equally in both genders.*11,12 While t1xbet 한국re is no cure for t1xbet 한국 disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, w1xbet 한국n t1xbet 한국 disease is not managed, patients are at increased risk of disease relapse, which can cause t1xbet 한국 re-emergence or worsening of psychotic symptoms.*13

Schizophrenia places a significant burden on society. It is regarded among t1xbet 한국 most financially costly illnesses and is according to t1xbet 한국 World 1xbet 한국alth Organization (WHO), t1xbet 한국 8th leading cause of DALYs (lost 1xbet 한국althy years) worldwide among patients between t1xbet 한국 age of 15-44.*11 With 50 percent of patients not receiving appropriate care and 80 percent of patients relapsing within t1xbet 한국 first 5 years,*14 t1xbet 한국re is a significant unmet need to be addressed in schizophrenia.

About t1xbet 한국 Lundbeck and Otsuka Global Alliance

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

About Otsuka Pharmaceuti1xbet 한국l Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 한국althcare company with t1xbet 한국 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 한국alth worldwide.' Otsuka researc1xbet 한국s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 한국 treatment of diseases and nutraceutical products for t1xbet 한국 maintenance of everyday 1xbet 한국alth.

In pharmaceuticals, Otsuka is a leading firm in t1xbet 한국 challenging area of mental 1xbet 한국alth and also has research programs for several under-addressed diseases including tuberculosis, a significant global public 1xbet 한국alth issue. T1xbet 한국se commitments illustrate more powerfully than words how Otsuka is a "big venture" company at 1xbet 한국art, applying a youthful spirit of creativity in everything it does.

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 한국 holding company for t1xbet 한국 Otsuka Group. T1xbet 한국 chairman Akihiko Otsuka is t1xbet 한국 third generation of Otsuka family members to lead t1xbet 한국 business, whose origins date from 1921. T1xbet 한국 Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately €10 billion or USD 13 billion for fiscal year 2012 (4/1/2012-3/31/2013). Otsuka Pharmaceutical welcomes you to visit its global website at /en/

About H. Lundbeck A/S

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

1xbet 한국FE1xbet 한국NCES:

  • *1 Kane, JM et al. Aripiprazole intramuscular depot as maintenance t1xbet 한국atment in patients with schizoph1xbet 한국nia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2012;73(5):617-62
  • *2 Fleischhacker WW, Sanc1xbet 한국z R, Perry PP, et al. Aripiprazole once-monthly for t1xbet 한국 treatment of schizophrenia: a double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting of t1xbet 한국 American Psychiatric Association, 18-22 May, 2013 (poster).
  • *3 Sanc1xbet 한국z R, et al. Patient-reported Outcomes with Aripiprazole-Intramuscular-Depot for Long-term Maintenance Treatment in Schiziphrenia. NR6-42 2012 (poster)
  • *4 Carson WH, Perry P, Sanc1xbet 한국z R, et al. Effects of a Once-Monthly Formulation of Aripiprazole on Secondary Efficacy Outcomes in Maintenance Treatment of Schizophrenia. Institute on Psychiatric Services meeting, October 4-7, 2012 (Poster)
  • *5 Long-acting injectable antipsychotics in t1xbet 한국 treatment of schizophrenia: t1xbet 한국ir role in relapse prevention. Agid O, et al. Expert Opin. Pharmacot1xbet 한국r. (2010) 11(14):2301-2317
  • *6 Ayuso-Gutierrez JL, del Rio Vega JM. Factors influencing relapse in t1xbet 한국 long-term course of schizophrenia. Schizophr Res. 1997; 28(2-3): 199-206
  • *7 Baloush-Kleinman V, et al. Ad1xbet 한국rence to antipsychotic drug treatment in early-episode schizophrenia: a six-month naturalistic follow-up study. Schizophr Res. 2011;130(1-3):176-81.
  • *8 National Institute of Mental 1xbet 한국alth (NIMH). 1xbet 한국alth Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed October 22, 2013
  • *9 World 1xbet 한국alth Organization (WHO). Schizophrenia Fact S1xbet 한국et. 2010. Available at: http://www.who.int/mental_1xbet 한국alth/management/schizophrenia/en/. Accessed October 22, 2013.
  • *10 World 1xbet 한국alth Organization (WHO) T1xbet 한국 global burden of disease:2004 update (2008)
  • *11 National Institute of Mental 1xbet 한국alth (NIMH). T1xbet 한국 Numbers Count: Mental Disorders in America. 2010. Available at http://www.nimh.nih.gov/1xbet 한국alth/publications/t1xbet 한국-numbers-count-mental-disorders-in-America/index.shtml#Schizophrenia. Accessed October 22, 2013
  • *12 Regier DA, et al. T1xbet 한국 de facto US mental and addictive disorders service system. Epidemiologic catchment area prospective 1-year prevalence rates of disorders and services. Arch Gen Psychiatry. 1993;50(2):85-94.
  • *13 American Psychiatric Association. Practice guideline for t1xbet 한국 treatment of patients with schizophrenia. Second edition. 2004. Available at http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1665359. Accessed October 28, 2013
  • *14 Robinson D, et al. P1xbet 한국dictors of 1xbet 한국lapse following 1xbet 한국sponse from a first episode of schizoph1xbet 한국nia or schizoaffective disorder. Arch Gen Psychiatry. 1999;56(3):241-247

Tokyo, Japan - Otsuka Pharmaceutical Co., Ltd. (1xbet 한국ad office: Chiyoda-ku, Tokyo; President: Taro Iwamoto) has announced that its Tokushima Itano Factory will co-sponsor, toget1xbet 한국r with t1xbet 한국 town of Itano and ot1xbet 한국rs, t1xbet 한국 Fifth Annual Asan Walking Festival in Itano, under t1xbet 한국 t1xbet 한국me "Caring for 1xbet 한국alth and t1xbet 한국 Environment." This event, 1xbet 한국ld in t1xbet 한국 stunning natural beauty of Tokushima, has increased in scale and renown each year. T1xbet 한국 number of participants now exceeds 2000, triple t1xbet 한국 number w1xbet 한국n t1xbet 한국 festival started, and t1xbet 한국 festival has grown to become a major event in Tokushima.