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

Osaka, Japan (ots/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 greater than
or equal to 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 D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it
has antagonistic 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 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(R) 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, http://www.ds-pharma.com.

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,?http://www.takeda.com.

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 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)
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

ots Originaltext: Takeda Pharmaceutical Company Limited and Dainippon Sumitomo Pharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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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