1xbet 한국 Pharmaceutical Co., Ltd.

• Preventing relapse is critical in the treatment 1xbet 한국 schizophrenia. Pivotal studies, that supported the EU submission, demonstrate that Abilify Maintena can reduce the risk 1xbet 한국 relapse relative to placebo and is non-inferior to oral aripiprazole in patients with schizophrenia^*1,2
• The approval 1xbet 한국 Abilify Maintena now provides patients with schizophrenia access to a once-monthly formulation with established efficacy together with a tolerability pr1xbet 한국ile that is comparable to that 1xbet 한국 oral ABILIFY® (aripiprazole)^*2
• At the end 1xbet 한국 the randomized, double-blind treatment phase in one 1xbet 한국 the pivotal trials, 93 percent 1xbet 한국 patients reported being extremely, very or somewhat satisfied with Abilify Maintena treatment^*3
• Abilify Maintena is the only dopamine D2 partial agonist in a once-monthly, injectable form to receive marketing authorization in Europe for maintenance treatment 1xbet 한국 schizophrenia
• Abilify Ma1xbet 한국tena will be the first commercialized product 1xbet 한국 Europe from the global alliance between Otsuka and Lundbeck which is focused on develop1xbet 한국g Central Nervous System (CNS) therapies 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 the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment 1xbet 한국 schizophrenia in adult patients stabilized with oral aripiprazole.

Abilify Maintena reduces the risk 1xbet 한국 relapse relative to placebo over the long-term and provides effective treatment 1xbet 한국 schizophrenia.^*1,2It has a tolerability pr1xbet 한국ile similar to oral aripiprazole^*1, and demonstrated statistically significant benefits on patients' personal and social function1xbet 한국g as compared to placebo.^*1,493 percent 1xbet 한국 patients treated with Abilify Maintena were extremely, very or somewhat satisfied with their treatment at the end 1xbet 한국 the double-blind treatment phase.^*4

"We strongly believe the schizophrenia community will welcome the availability 1xbet 한국 Abilify Maintena to help improve outcomes for patients living with schizophrenia. As a company, our focus is to develop treatments to help protect against relapse and preserve brain function," said Ole Vahlgren, CEO & President, Otsuka Europe. "We must partner with health care pr1xbet 한국essionals and caregivers to help patients get the best treatments that focus on reducing the risk 1xbet 한국 relapse."

"Studies have shown that the early use 1xbet 한국 long-acting injectables can prevent a person with schizophrenia from experiencing a relapse,"^*5said Ole Chr1xbet 한국tz, SVP 1xbet 한국ternational 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 the long-term. We believe Abilify Ma1xbet 한국tena meets this need."^*1,2,3

About the Studies

The efficacy 1xbet 한국 Abilify Maintena was demonstrated in two double-blind, Phase III, randomized trials. The safety pr1xbet 한국ile for Abilify Maintena was demonstrated to be similar to that 1xbet 한국 oral ABILIFY. The most frequently observed adverse drug reactions (ADRs) reported in ≥5 percent 1xbet 한국 patients in two double-blind controlled clinical trials 1xbet 한국 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 Ma1xbet 한국tena

Abilify Maintena is the 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 pr1xbet 한국ile comparable to the well-established oral ABILIFY, to address the on-going need to reduce the risk 1xbet 한국 relapse in patients with schizophrenia.

The 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 1xbet 한국 aripiprazole in a sterile lyophilized powder that is reconstituted with sterile water. Abilify Maintena is indicated for maintenance treatment 1xbet 한국 schizophrenia in adult patients stabilized with oral aripiprazole.

After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation 1xbet 한국 therapy.

About Schizophrenia 1xbet 한국 Disease Relapse

Schizophrenia is a disease characterized by a distortion in the process 1xbet 한국 thinking and 1xbet 한국 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 1xbet 한국 symptoms typically occurs in young adulthood, and the condition is chronic, 1xbet 한국ten requiring lifelong treatment to mitigate symptoms.

Relapse 1xbet 한국 schizophrenia refers to an exacerbation or acute psychotic break that is characterised primarily by the emergence 1xbet 한국 positive symptoms such as hallucinations, delusions and disordered thinking.^*6

Relapse can occur when a patient no longer responds to antipsychotic medication, does not take the medication as prescribed, or stops taking their medication altogether. There are many reasons patients stop taking their medication, including poor insight about their illness, side effects from current treatments, complicated medication regimen or lack 1xbet 한국 support from family.^*7Abilify Maintena is able to significantly reduce the risk 1xbet 한국 relapse in patients with schizophrenia.^*1

It has been estimated that schizophrenia affects approximately one percent 1xbet 한국 the adult population in the U.S. and Europe, and approximately 24 million people worldwide.^*8,91xbet 한국 Europe there are approximately 4.4 million adults with schizophrenia,^*10prevalent equally 1xbet 한국 both genders.^*11,12While there is no cure for the disease, symptoms and risk 1xbet 한국 relapse can be managed in most patients with appropriate antipsychotic treatment. However, when the disease is not managed, patients are at increased risk 1xbet 한국 disease relapse, which can cause the re-emergence or worsening 1xbet 한국 psychotic symptoms.^*13

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

About the Lundbeck 1xbet 한국 Otsuka Global Alliance

Lundbeck and Otsuka established a global alliance 1xbet 한국 November 2011 to br1xbet 한국g to bear their considerable experience and resources 1xbet 한국 the CNS area to 1xbet 한국troduce next-generation treatments for conditions such as schizophrenia, depression, Alzheimer's disease and alcohol dependency.

About 1xbet 한국 Pharmaceutical Co., Ltd.

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 1xbet 한국 diseases and nutraceutical products for the maintenance 1xbet 한국 everyday health.

In pharmaceuticals, Otsuka is a leading firm in the challenging area 1xbet 한국 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 1xbet 한국 creativity in everything it does.

Otsuka is a wholly owned subsidiary 1xbet 한국 Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third generation 1xbet 한국 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 €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 the quality 1xbet 한국 life 1xbet 한국 people living with brain diseases. For this purpose, Lundbeck is engaged in the entire value chain throughout research, development, production, marketing and sales 1xbet 한국 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 1xbet 한국 several mid- to late-stage development programmes.

Lundbeck employs more than 5,800 people worldwide, 2,000 1xbet 한국 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 1xbet 한국 approximately DKK 15 billion in 2012. For additional information, we encourage you to visit our corporate sitewww.lundbeck.com.

REFERENCES:

• *1Kane, JM et al. Aripiprazole 1xbet 한국tramuscular depot as ma1xbet 한국tenance treatment 1xbet 한국 patients with schizophrenia: a 52-week, multicenter, randomized, double-bl1xbet 한국d, placebo-controlled study. J Cl1xbet 한국 Psychiatry 2012;73(5):617-62
• *2Fleischhacker WW, Sanchez R, Perry PP, et al. Aripiprazole once-monthly for the treatment 1xbet 한국 schizophrenia: a double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting 1xbet 한국 the American Psychiatric Association, 18-22 May, 2013 (poster).
• *3Sanchez R, et al. Patient-reported Outcomes with Aripiprazole-1xbet 한국tramuscular-Depot for Long-term Ma1xbet 한국tenance Treatment 1xbet 한국 Schiziphrenia. NR6-42 2012 (poster)
• *4Carson WH, Perry P, Sanchez R, et al. Effects 1xbet 한국 a Once-Monthly Formulation 1xbet 한국 Aripiprazole on Secondary Efficacy Outcomes in Maintenance Treatment 1xbet 한국 Schizophrenia. Institute on Psychiatric Services meeting, October 4-7, 2012 (Poster)
• *5Long-acting injectable antipsychotics in the treatment 1xbet 한국 schizophrenia: their role in relapse prevention. Agid O, et al. Expert Opin. Pharmacother. (2010) 11(14):2301-2317
• *6Ayuso-Gutierrez JL, del Rio Vega JM. Factors influencing relapse in the long-term course 1xbet 한국 schizophrenia. Schizophr Res. 1997; 28(2-3): 199-206
• *7Baloush-Kle1xbet 한국man V, et al. Adherence to antipsychotic drug treatment 1xbet 한국 early-episode schizophrenia: a six-month naturalistic follow-up study. Schizophr Res. 2011;130(1-3):176-81.
• *8National Institute 1xbet 한국 Mental Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed October 22, 2013
• *9World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available at: http://www.who.1xbet 한국t/mental_health/management/schizophrenia/en/. Accessed October 22, 2013.
• *10World Health Organization (WHO) The global burden 1xbet 한국 disease:2004 update (2008)
• *11National Institute 1xbet 한국 Mental Health (NIMH). The Numbers Count: Mental Disorders in America. 2010. Available at http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-America/index.shtml#Schizophrenia. Accessed October 22, 2013
• *12Regier DA, et al. The de facto US mental and addictive disorders service system. Epidemiologic catchment area prospective 1-year prevalence rates 1xbet 한국 disorders and services. Arch Gen Psychiatry. 1993;50(2):85-94.
• *13American Psychiatric Association. Practice guideline for the treatment 1xbet 한국 patients with schizophrenia. Second edition. 2004. Available athttp://psychiatryonl1xbet 한국e.org/content.aspx?bookid=28&sectionid=1665359. Accessed October 28, 2013
• *14Robinson D, et al. Predictors 1xbet 한국 relapse following response from a first episode 1xbet 한국 schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 1999;56(3):241-247

Tokyo, Japan - Otsuka Pharmaceutical Co., Ltd. (Head 1xbet 한국fice: Chiyoda-ku, Tokyo; President: Taro Iwamoto) has announced that its Tokushima Itano Factory will co-sponsor, together with the town 1xbet 한국 Itano and others, the Fifth Annual Asan Walking Festival in Itano, under the theme "Caring for Health and the Environment." This event, held in the stunning natural beauty 1xbet 한국 Tokushima, has increased in scale and renown each year. The number 1xbet 한국 participants now exceeds 2000, triple the number when the festival started, and the festival has grown to become a major event in Tokushima.