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

Zurich (ots/PRNewswire) -

LATUDA(R) (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.

ots Originaltext: Takeda Pharmaceuticals Europe Ltd
Im Internet recherchierbar: http://www.presseportal.de

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