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Dainippon Sumitomo Pharma and Takeda Receive Positive CHMP Opinion for Lurasidone - a New Atypical Antipsychotic Medication for

    Dainippon Sumitomo Pharma and Takeda Receive Positive CHMP Opinion for      Lurasidone - a New Atypical Antipsychotic Medication for Adults with                                 Schizophrenia    PR Newswire    OSAKA, Japan, January 24, 2014  OSAKA, Japan, January 24, 2014 /PRNewswire/ --  Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited ("Takeda") (Head Office: Osaka, Japan) today jointly announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a Positive Opinion for lurasidone for the treatment of schizophrenia in adults. Lurasidone is a once-daily oral treatment that is currently available in Switzerland, the United States and Canada having been approved for use by the respective regulatory authorities.  The Positive CHMP Opinion was based on a comprehensive clinical trial program which included placebo and active comparators. Lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia over 6 weeks. ^[ ^1 ^] ^, ^[ ^2 ^] ^, ^[ ^3 ^] ^, ^[ ^4 ^] ^, ^[ ^5 ^] In short and longer term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change. ^[ ^1 ^] ^, ^[ ^2 ^] ^, ^[ ^6 ^] It is important to minimize the adverse effect of treatments on long-term physical health as patients are likely to remain on therapy for many years.  Lurasidone was generally well-tolerated and had low rates of weight increase, as well as lipid and glucose disturbance, in the treatment of patients with schizophrenia. The most frequent adverse reactions seen in short-term clinical studies (incidence ≥ 5% and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, Parkinsonism and dystonia. ^[ ^7 ^]  "As a  practicing  psychiatrist, I am interested in new, effective agents for the treatment of severely ill patients with mental disorders. We need effective, well-tolerated and metabolically neutral  treatment  alternatives. Lurasidone has an interesting profile , which could benefit many patients with schizophrenia " says Philipp Eich MD, Klinik für Psychiatrie und Psychotherapie, Liestal, Switzerland.  Data for lurasidone was presented at last year's European College of Neuropsychopharmacology (ECNP) Congress showing lurasidone to have a favourable metabolic side effect profile ^[ ^8 ^] ^, ^[ ^9 ^] ^, ^[ ^10 ^] ^, ^[ ^11 ^] and to be a well-tolerated, efficacious option for patients with schizophrenia switching medication. ^[ ^11 ^]  About Lurasidone  Lurasidone is an atypical antipsychotic, developed originally by Dainippon Sumitomo Pharma Co., Ltd. ("DSP") with a high affinity for dopamine D [2] , serotonin 5-HT [2A] and serotonin 5-HT [7] receptors where it has antagonistic effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT [1A] receptor and has no appreciable affinity for histamine or muscarinic receptors. Lurasidone was approved for the treatment of schizophrenia by the United States Food and Drug Administration in October 2010, by Health Canada in June 2012, and by the Swiss Agency for Therapeutic Products in August 2013. Lurasidone was launched as LATUDA ^® for the treatment of schizophrenia in adults in the United States in February 2011 and in Canada in September 2012 through DSP's subsidiary Sunovion Pharmaceuticals Inc., and in Switzerland in September 2013 through Takeda. In Japan a Phase III clinical study is underway for the treatment of schizophrenia by DSP. An application has been filed with the Australian Therapeutic Goods Administration for the treatment of patients with schizophrenia, as well as the Taiwan Food and Drug Administration (TFDA) and further development in the Chinese and Southeast Asian markets is planned.  About schizophrenia  Schizophrenia is a severe chronic mental condition which can affect both men and women. Patients with schizophrenia have a life span that is decreased by approximately 10-22.5 years compared with the general population. ^[1][ ^2 ^] , ^[ ^13 ^] , ^[ ^14 ^] , ^[ ^15 ^]  Antipsychotic pharmacotherapy is the cornerstone of treatment for patients with schizophrenia, with agents generally classed as typical or atypical. Atypical agents are broadly considered to have tolerability benefits over typical agents. ^[ ^16 ^] Switching antipsychotic medication is common in the treatment of patients with schizophrenia either due to residual or emergent symptoms, adverse events or tolerability issues. ^[ ^17 ^] ^, ^[ ^18 ^]  Direct and indirect costs associated with caring for patients with schizophrenia are considerable and can include utilization of other health services, pharmacotherapy, community care, supportive therapy, informal care and private expenditures, and patient and caregiver lost productivity. ^[ ^19 ^] ^, ^[ ^20 ^] Hospitalization associated with patient relapse can significantly increase costs associated with disease management in schizophrenia. ^[ ^21 ^]  About Dainippon Sumitomo Pharma Co., Ltd.  Dainippon Sumitomo Pharma Co., Ltd., defines its corporate mission as "to broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives for people worldwide". By pouring all our efforts into the research and development of new drugs, we aim to provide innovative and effective pharmaceutical solutions to people not only in Japan but also around the world in order to realize our corporate mission. Additional information about DSP is available through its corporate website, .  About Takeda Pharmaceutical Company Limited  Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, .  References  1.Meltzer H et al. Am J Psychiatry 2011;168:957-67 2.Loebel A et al. Schizophr Res 2013;145(1-3):101-9 3.Nakamura M et al. J Clin Psychiatry 2009;70:829-36 4.Ogasa M et al. Psychopharmacol [Berl] 2013;225(3):519-30 5.Nasrallah H et al. J Psychiatric Research 2013;47(5):670-7 6.Citrome L et al. Int Clin Psychopharmacol 2012;27:165-76 7.Company Core Data Sheet (Table 4). 8.Murthy et al. Lurasidone for the treatment of schizophrenia: pooled     analysis of short-term, placebo-controlled trials (Abstract presented at     ECNP, 8 October 2013) 9.Lieberman J.A. et al. Lurasidone in the treatment of early-stage     schizophrenia: a post-hoc analysis of three pooled acute treatment studies     (Abstract presented at ECNP, 8 October 2013) 10.Pikalov A et al. Eur Neuropsychopharmacol 2012;22(Suppl 2):S340 11.McEvoy al. Switching to lurasidone in patients with schizophrenia:     tolerability and effectiveness at 6 weeks and 6 months (Abstract presented     at ECNP, 8 October 2013) 12.Healy D et al. Mortality in schizophrenia and related psychoses: data from     two cohorts, 1875-1924 and 1994-2010. BMJ Open 2012;2:e001810 13.Chang C-K et al. Life Expectancy at Birth for People with Serious Mental     Illness and Other Major Disorders from a Secondary Mental Health Care Case     Register in London. PLoS One 2011;6:e19590 14.Laursen TM. Life expectancy among persons with schizophrenia or bipolar     affective disorder. Schizophr Res 2011;131:101-4 15.Tiihonen J et al . 11 year-follow up of mortality in patients with     schizophrenia: a population-based cohort study (FINN11 study). Lancet     2009;374:620-7 16.Lewis DA and Lieberman JA. Neuron 2000;28:325-34 17.Faries DE et al. Clinical and economic ramifications of switching     antipsychotics in the treatment of schizophrenia . BMC Psych 2009;9:54 18.Tsutsumi C et al. The evolution of antipsychotic switch and polypharmacy     in natural practice - A longitudinal perspective. Schizophr Res     2011;130:40-6 19.Salize HJ et al. Cost of schizophrenia in six European countries.     Schizophr Res 2009;111(1-3):70-7 20.Mangalore R and Knapp R. Cost of schizophrenia in England. J Ment Health     Policy Econ 2007;10(1):23-41 21.Zeidler J et al. The costs of schizophrenia and predictors of     hospitalisation from the statutory health insurance perspective. Health     Econ Rev 2012;2(1):9  Contact: Media Contacts Sunovion Europe Media Contacts Stephanie Snow +44 7747 636 838 Emily Ko +44 7513 037066 Takeda Media Contacts Elissa Johnsen Takeda Pharmaceuticals International GmbH +1 224 554 3185 Red Door Communications +44 7787 643964 Media Contacts in Japan: Dainippon Sumitomo Pharma Co., Ltd. Corporate Communications Dept. Phone: +81-6-6203-1407 (Osaka), +81-3-5159-3300 (Tokyo) Takeda Pharmaceutical Company Limited Corporate Communications Dept. (PR/IR) Phone: +81-3-3278-2037