First Country in Europe Launches LATUDA® (lurasidone) - a New Atypical Antipsychotic for Adults with Schizophrenia

ZURICH, September 10, 2013 /PRNewswire/ --

LATUDA^® (lurasidone), a new once-daily treatment for schizophrenia, is now available in Switzerland for the treatment of schizophrenia.^[1] Research has shown that the atypical antipsychotic, lurasidone, has a specific receptor binding profile.^[2]

Symptom control and reducing relapse are primary goals of schizophrenia therapy.^[3] Lurasidone has been shown in clinical trials to offer both short and long-term efficacy with a rapid onset of action that has demonstrated effective symptom control as early as day four of treatment.^[4] It has also been shown to offer consistency of response across efficacy measures of schizophrenia symptoms.^[5]

In addition to effective symptom control, it is important to minimize the effect of treatment on long-term physical health as patients are likely to need to remain on therapy for many years. Research has shown that there can be associated problematic side effects such as weight gain and cholesterol increases with schizophrenia treatments - both of which can lead to metabolic and cardiovascular concerns in the longer term.^[6] Recent research has shown that lurasidone has a combination of efficacy and a favourable side effect profile^[7] which may help patients maintain their cardiometabolic health and thereby improve their outcomes in the long term.  

"As a committed 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 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.

Schizophrenia affects around 80,000 people in Switzerland and can affect both men and women, with symptoms emerging in early adulthood.^[8] As a severe, chronic mental illness, the course of schizophrenia varies, but it is generally characterized by psychotic episodes, with underlying negative and cognitive symptoms and incomplete recovery between episodes.^[8] Symptoms of the condition can include so-called positive symptoms such as delusions,^[8] hallucinations,^[8] reality distortion^[8] and so-called negative symptoms such as, blunted affect, emotional and social withdrawal/drive.^[8]

"Today is an important landmark for Takeda in Europe as it marks our first launch of a medicine from our emerging CNS portfolio-lurasidone is animportant driver in our initiatives to expand the franchise for specialty care in Europe. We have a broad range of medicines in development in significant areas of unmet clinical need and we look forward to bringing innovative treatments to market that bring benefits to the widest range of patients possible," said Rene Gilvert, Vice President Global Marketing and Therapeutic Area Lead CNS, Takeda Pharmaceuticals International.

Takeda has also 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 indicated for the treatment of patients with schizophrenia. The effectiveness and efficacy of lurasidone for longer-term use (for more than six weeks), has also been established in controlled studies.^[9],^[10]

Lurasidone has been licensed in Switzerland for the treatment of schizophrenia. Lurasidone was created and developed by Dainippon Sumitomo Pharma Co. Ltd. and received FDA approval in October 2010 and has been available in the US since 2011. It was also approved by Health Canada for adults with schizophrenia in August 2011.

Please see important safety information including the black triangle information and full prescribing information at Latuda Fachinformation, http://www.swissmedicinfo.ch

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.^[11],^[12],^[13],^[14]

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.^[15] Switching antipsychotic medication is common in the treatment of patients with schizophrenia either due to residual or emergent symptoms, adverse events or tolerability issues.^[16],[17]

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.^[18],[19] Hospitalization associated with patient relapse can significantly increase costs associated with disease management in schizophrenia.^[20]

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.

References

1. Latuda Fachinformation, June. 2013, Takeda Pharma AG. Available from: http://www.swissmedicinfo.ch

2. Ishibashi T. Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity. J Pharmacol Exp Ther. 2010 Jul;334(1):171-81.

3. Ventura J et al. Remission and Recovery during the First Outpatient Year of the Early Course of Schizophrenia. Schizophr Res 2011;132(1):18−23.

4. Swiss SmPC - June 2013

5. Nakamura M et al. Lurasidone in the Treatment of Acute Schizophrenia: A Double-Blind, Placebo-Controlled Trial. J Clin Psychiatry 2009;70(6):829−836

6. Daumit GL et al. Antipsychotic effects on estimated 10-year coronary heart disease risk in the CATIE schizophrenia study. Schizophr Res 2008 105(1-3):175−187.

7. Loebel et al. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophrenia Research 2013 147 95-102.

8. Tandon RT et al. Schizophrenia, "just the facts" 4. Clinical features and conc~ptualization. Schizophr Res 2009;110:1-23.

9. Citrome L et al. Int Clin Psychopharmacol 2012;27:165-76

10. Meltzer H et al. Lurasidone in the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo- and Olanzapine- Controlled Study. Am J Psychiatry 2011;168:957-67.

11. Healy D et al. Mortality in schizophrenia and related psychoses: data from two cohorts, 1875-1924 and 1994-2010. BMJ Open 2012;2:e001810.

12. 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.

13. Laursen TM. Life expectancy among persons with schizophrenia or bipolar affective disorder. Schizophr Res 2011;131:101-4.

14. Tiihonen J et al. 11 year-follow up of mortality in patients with scizophrenia: a population-based cohort study (FINN11 study). Lancet 2009;374:620-7.

15. Lewis DA and Lieberman JA. Neuron 2000;28:325-34.

16. Faries DE et al. Clinical and economic ramifications of switching antipsychotics in the treatment of schizophrenia. BMC Psych 2009;9:54.

17. Tsutsumi C et al. The evolution of antipsychotic switch and polypharmacy in natural practice - A longitudinal perspective. Schizophr Res 2011;130:40-6.

18. Salize HJ et al. Cost of schizophrenia in six European countries. Schizophr Res 2009;111(1-3):70-7.

19. Mangalore R and Knapp R. Cost of schizophrenia in England. J Ment Health Policy Econ 2007;10(1):23-41.

20. 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.