Takeda Pharmaceuticals Europe Ltd

Five Scientific Posters Supporting the Efficacy and Tolerability of Once-Daily Lurasidone - A New Atypical Antipsychotic Treatment for Adults with Schizophrenia

Barcelona, Spain (ots/PRNewswire) - 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 action[1], a favourable side effect profile [1],[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 weeks[5]. 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 greater than or equal to7% 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.

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.

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(R) 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]

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, http://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 http://www.sunovion.eu.

This press release does not necessarily reflect the opinions of ECNP.

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)

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. BMJ Open 2012;2:e001810.

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 2011;131:101-4.

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. BMC Psych 2009;9:54.

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

Contact:

Takeda Media Enquiry Contacts: Kate Burd, Takeda Pharmaceuticals
International GmbH, +44-7974-151510, kate.burd@takeda.com; Abi
Thomson, Red
Door Communications, +44(0)20-8392-8049, athomson@rdcomms.com;
Sunovion
Europe Media Enquiry contacts: Stephanie Snow, +44-7747-636-838,
stephanie.snow@munroforster.com, Emily Ko, +44-7513-037066,
emily.ko@munroforster.com


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