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

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

  PR Newswire

  OSAKA, Japan, January 24, 2014

OSAKA, Japan, January 24, 2014 /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 ≥ 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 D [2] ,
serotonin 5-HT [2A] and serotonin 5-HT [7] receptors where it has antagonistic
effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT
[1A] 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 ^® 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 .


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
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13.Chang C-K et al. Life Expectancy at Birth for People with Serious Mental
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15.Tiihonen J et al . 11 year-follow up of mortality in patients with
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16.Lewis DA and Lieberman JA. Neuron 2000;28:325-34
17.Faries DE et al. Clinical and economic ramifications of switching
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18.Tsutsumi C et al. The evolution of antipsychotic switch and polypharmacy
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19.Salize HJ et al. Cost of schizophrenia in six European countries.
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21.Zeidler J et al. The costs of schizophrenia and predictors of
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Contact: Media Contacts Sunovion Europe Media Contacts Stephanie Snow +44 7747
636 838 stephanie.snow@munroforster.com Emily Ko +44 7513 037066
emily.ko@munroforster.com Takeda Media Contacts Elissa Johnsen Takeda
Pharmaceuticals International GmbH +1 224 554 3185 elissa.johnsen@takeda.com
Red Door Communications +44 7787 643964 cgrindal@rdcomms.com 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
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