Microsoft word - lurmt001z13 - ecnp press release final.doc

This press release does not necessarily reflect the opinions of ECNP

FOR MEDICAL MEDIA

Five Scientific Posters Supporting the Efficacy and Tolerability of Once-Daily Lurasidone – A New
Atypical Antipsychotic treatment for Adults with Schizophrenia
Barcelona, 9 October, 2013 – On the occasion of the 26th European College of Neuropsychopharmacology
Congress (ECNP), with educational financial support provided by Takeda and Sunovion Pharmaceuticals
Europe, new data was presented showing both short and long-term efficacy for lurasidone, an atypical
antipsychotic treatment for schizophrenia. These data also showed lurasidone to have early separation from
placebo, a rapid onset of action1, a favourable side effect profile1,2,3,4 and to be a well-tolerated, efficacious
option for patients with schizophrenia switching medication.4 Lurasidone has been approved in US, Canada
and Switzerland and is currently under regulatory review in Europe.
The data included a post–hoc analysis of double-blind controlled studies showing how insight (awareness of
illness), when measured by PANSS score, was significantly improved for clinically unstable patients given
once-daily lurasidone 80 mg, lurasidone 160 mg and active control quetiapine XR 600 mg, compared to
placebo, after 6 weeks5. At week 32, insight was significantly greater for those treated with lurasidone
compared with quetiapine XR. Increased insight was shown to predict improvements in specific cognitive
measures.
Two post-hoc pooled analyses of a number of short-term trials demonstrated that lurasidone is an efficacious
treatment with a favourable safety profile. One analysis demonstrated that lurasidone has early separation
from placebo by Week 1 and that the 160 mg dosage may provide significant additional efficacy benefit.1
Side-effects were minimal regarding weight-gain, metabolic parameters and prolactin. The second analysis
looked at patients with early-stage schizophrenia, as evidence suggests that they may be particularly
sensitive to antipsychotics in general.2 In both analyses, those treated with lurasidone experienced
significantly greater improvement at Week 6 compared with placebo on PANSS total and subscale scores
(positive and negative) and CGI-Severity score.
"As a dedicated psychiatrist, I am interested in new, effective agents for the treatment of severely ill patients with mental disorders. This is particularly true for patients who are not suitable for or who have not responded to currently approved therapeutics. We need effective, well-tolerated and metabolically neutral alternatives, which can also be used in young patients. Lurasidone has an interesting profile of action." says Dr Philipp Eich, Stv Chefarzt, Kantonale Psychiatrische Klinik Liestal, Switzerland. A further presentation of the results of two randomized controlled long-term (12-month) trials provided a head-to-head comparison of the safety and effectiveness of lurasidone and quetiapine XR (D1050234), and lurasidone and risperidone (D1050237).3 Lurasidone’s side-effect profile was favourable compared to quetiapine XR. The safety profile showed, in part, clinically significant weight gain (defined as ≥7% weight gain from baseline) in 7.0% and 14.0% of patients treated with lurasidone vs risperidone, and in 11.5% and 15.2% of patients treated with lurasidone vs quetiapine, respectively. Date of preparation: October 2013 Job number: EUCAN/LUR/2013-10013 - LUR/MT/001z/13 This press release does not necessarily reflect the opinions of ECNP
Median changes in prolactin from baseline at month 12 were 0.0/+0.95 ng/ml (for lurasidone, male/female)
and +7.5/+24.6 ng/ml (for risperidone, male/female). Overall, results of these two double-blind 12 month
trials suggest that lurasidone was effective and well-tolerated over 12 months of treatment.
Minimal changes in weight and lipid parameters were also shown after 6 months in data evaluating the
safety, tolerability and effectiveness of switching other antipsychotic medication to lurasidone.4 Switching
antipsychotic medication is common in schizophrenia treatment either due to residual or emergent
symptoms, adverse events or tolerability issues. Data from a randomized open-label switch extension study
showed that lurasidone was well-tolerated and that switched patients generally maintained or improved their
control of symptoms.4
“Schizophrenia can have a devastating effect on people’s lives, and they, and the healthcare professionals
who treat them, need a broader range of effective treatment choices. Takeda is committed to bringing
innovative medicines to areas of unmet clinical need, offering benefits to the widest range of patients
possible.” said Rene Gilvert, Vice President Global Marketing and Therapeutic Area Lead CNS, Takeda
Pharmaceuticals International.

“The data show lurasidone provides efficacy in multiple aspects of the complex illness of schizophrenia.
Lurasidone has a low incidence of side effects observed, whilst providing needed efficacy for patients with
schizophrenia.” said Tony Hale, Medical Director, Sunovion Pharmaceuticals Europe.

Takeda has submitted a marketing authorization application (MAA) for lurasidone in October 2012 to the
European Medicines Agency (EMA). Takeda will communicate the outcome of this application in the
coming months.
-- Ends –

About Lurasidone
Lurasidone is an atypical antipsychotic, developed originally by Dainippon Sumitomo Pharma Co., Ltd.
(DSP) with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has
antagonist effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no
appreciable affinity for histamine or muscarinic receptors. Lurasidone (brand name LATUDA® in
Switzerland, Canada and the United States) was approved for the treatment of schizophrenia by the United
States Food and Drug Administration in October 2010 and by Health Canada in June 2012. Lurasidone was
launched in the United States for the treatment of schizophrenia in adults in February, 2011 and in Canada in
September, 2012 through DSP’s subsidiary Sunovion Pharmaceuticals Inc. An application has been filed
with the Australian Therapeutic Goods Administration for the treatment of patients with schizophrenia, and
development in the Chinese and Southeast Asian markets is planned. Additionally, Lurasidone received
FDA approval for the treatment of patients with major depressive episodes associated with bipolar I disorder
(bipolar depression) in June 2013.
The data presented include posters that were jointly developed by Sunovion Pharmaceuticals Inc., the U.S.
subsidiary of Dainippon Sumitomo Pharma Co. Ltd. (DSP) and Takeda.
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.6,7,8,9
Date of preparation: October 2013 Job number: EUCAN/LUR/2013-10016g - LUR/MT/001z/13 This press release does not necessarily reflect the opinions of ECNP
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.10 Switching antipsychotic medication is common in the treatment of patients with
schizophrenia either due to residual or emergent symptoms, adverse events or tolerability issues.11,12

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.13,14 Hospitalization associated with
patient relapse can significantly increase costs associated with disease management in schizophrenia.15

About Takeda Pharmaceuticals International GmbH
Takeda Pharmaceuticals International GmbH, headquartered in Zurich, is a wholly owned subsidiary of
Takeda Pharmaceutical Company Limited. As the largest pharmaceutical company in Japan and a leader in
the global industry, Takeda’s mission is to strive toward better health for patients worldwide through leading
innovation in medicine. It has a commercial presence covering more than 70 countries, with particular
strength in Asia, North America, Europe and fast-growing emerging markets including Latin America,
Russia-CIS and China. Takeda is ranked 12th by global Rx sales, 14th in the BRIC countries and 18th in
Europe. Takeda’s commercial presence mainly covers the therapeutic areas of metabolic diseases,
gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders,
respiratory diseases and pain management. Additional information about Takeda is available through its
corporate website, www.takeda.com.
About Sunovion Pharmaceuticals Europe Ltd.
Sunovion Pharmaceuticals Europe headquartered in London, a wholly owned subsidiary of 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”. Sunovion Europe is focused on the development and introduction of innovative
medicines that improve people’s health and wellbeing. The Company’s focus is in Psychiatry and
Neurology, including mental illness, and other disease areas of significant unmet need which require highly
specialised drug development. Additional information about Sunovion Europe is available through its
corporate website www.sunovion.eu.
Takeda Media Enquiry Contacts
Kate
Takeda Pharmaceuticals International GmbH
Sunovion Europe Media Enquiry contacts:
Stephanie

References

1. Murthy et al. Lurasidone for the treatment of schizophrenia: pooled analysis of short-term, placebo-controlled trials
(Abstract presented at ECNP, 8 October 2013) Date of preparation: October 2013 Job number: EUCAN/LUR/2013-10016g - LUR/MT/001z/13 This press release does not necessarily reflect the opinions of ECNP
2 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) 3. Pikalov A.et al. Comparative effectiveness of long-term treatment with atypical antipsychotics in patients with schizophrenia (Abstract presented at ECNP, 8 October 2013) 4. McEvoy J.P.et al. Switching to lurasidone in patients with schizophrenia: tolerability and effectiveness at 6 weeks and 6 months (Abstract presented at ECNP, 8 October 2013) 5. Harvey P. et al. Impact of improved insight in schizophrenia: a double-blind lurasidone and quetiapine XR study (Abstract presented at ECNP, 8 October 2013) 6. Healy D et al. Mortality in schizophrenia and related psychoses: data from two cohorts, 1875–1924 and 1994–2010. 7. 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. 8. Laursen TM. Life expectancy among persons with schizophrenia or bipolar affective disorder. Schizophr Res 9. 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. 10. Lewis DA and Lieberman JA. Neuron 2000;28:325–34. 11. Faries DE et al. Clinical and economic ramifications of switching antipsychotics in the treatment of schizophrenia. 12. Tsutsumi C et al. The evolution of antipsychotic switch and polypharmacy in natural practice — A longitudinal perspective. Schizophr Res 2011;130:40–6. 13. Salize HJ et al. Cost of schizophrenia in six European countries. Schizophr Res 2009;111(1–3):70–7. 14. Mangalore R and Knapp R. Cost of schizophrenia in England. J Ment Health Policy Econ 2007;10(1):23–41. 15. 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. Date of preparation: October 2013 Job number: EUCAN/LUR/2013-10016g - LUR/MT/001z/13

Source: http://www.sunovion.eu/news/20131009.pdf