Multiple Scientific Posters Supporting the Efficacy, Safety and Tolerability of Once-daily Latuda® (lurasidone) are Presented at the 27th ECNP Congress

Berlin (ots/PRNewswire) -

Takeda Pharmaceuticals International GmbH ("Takeda") and Sunovion
Pharmaceuticals Inc. ("Sunovion") presented new evidence supporting
the use of Latuda(R) (lurasidone), an atypical antipsychotic
treatment for adults with schizophrenia, during multiple poster
sessions at the 27th European College of Neuropsychopharmacology
(ECNP).

New data presented support Latuda's short and long-term efficacy,
as well as preventing relapse.[1],[2],[3],[4],[5] These new data also
support Latuda as a tolerable option for patients switching
medication from risperidone, having a low propensity for weight gain
with minimal effects on cardiovascular and metabolic parameters.[2]

Abstract [P.3.d.061]: 'Effect of lurasidone or risperidone on
metabolic syndrome status in patients with schizophrenia: a post hoc
analysis of a long-term study'

In one multi-regional, double blind study, Latuda was shown to
reduce the risk of adult patients with schizophrenia developing
metabolic syndrome,[1] which is associated with cardiovascular
morbidity and mortality.[1] Results showed that among patients
without metabolic syndrome at baseline, after 12 months of treatment
the risk of developing metabolic syndrome was reduced by 48% in
patients treated with flexibly dosed once-daily Latuda (37-111 mg/d)
relative to patients treated with flexibly dosed risperidone (2-6
mg/d) (HR 0.52; 95% CI, 0.24-1.15).[1] In addition, in patients who
completed 12 months of risperidone treatment, metabolic syndrome
prevalence decreased after a switch to Latuda in a six-month open
label extension study.[1] Furthermore, after 12 months of
double-blind risperidone treatment, the prevalence of metabolic
syndrome was 48.4%, which subsequently decreased to 38.5% after six
months of open-label Latuda treatment.[1]

Abstract [P.3.d.062]: 'An open-label extension study of lurasidone
in patients with schizophrenia previously randomized to lurasidone or
risperidone'

For adult patients switching medication, Latuda was found to be a
well-tolerated and efficacious option in a six-month open-label
extension (OLE) study.[2] Results from this study showed that
switching to Latuda after 12 months of double-blind treatment with
risperidone was associated with a mean change in weight of -2.9 kg,
whereas patients who continued on Latuda experienced a -0.6 kg mean
weight loss after an additional six months of treatment at the study
endpoint.[2] In addition, patients who switched from risperidone
demonstrated a decrease in prolactin levels (median change from
open-label extension study baseline to endpoint: men, -11.2 ng/mL;
women, -30.8 ng/mL).[2]

"Due to the chronic nature of schizophrenia, clinicians need to
consider not only the efficacy of an antipsychotic medication in
managing patients' symptoms, but also the potential impact on
metabolic syndrome," said Antony Loebel, M.D., Executive Vice
President and Chief Medical Officer, Sunovion Pharmaceuticals Inc.
"We are encouraged to see these long-term data, which show Latuda was
both effective, well-tolerated and associated with a low propensity
for metabolic syndrome."

Abstract [P.3.d.065]: 'Evaluation of daytime sleepiness in
patients with schizophrenia treated with atypical antipsychotics'

Daytime sleepiness associated with antipsychotic treatment may
adversely impact functional performance and quality of life.[3] A
post-hoc analysis of a six-week, double-blind study in adult patients
with schizophrenia compared the effects of Latuda and quetiapine XR
on prospectively measured daytime sleepiness (also known as daytime
somnolence or sedation).[3] Results demonstrated that daytime
sleepiness improved in the Latuda and placebo-treated groups.[3]
Daytime sleepiness worsened in the quetiapine XR treatment group when
compared to placebo (p=0.001) and to either dose of Latuda
(p<0.01).[3]

Abstract [P.3.d.060]: 'Efficacy of lurasidone in the treatment of
schizophrenia with prominent negative symptoms: a post hoc analysis
of five short-term trials'

Efficacy of Latuda in treating both positive and negative symptoms
in acutely psychotic adult patients with schizophrenia was
demonstrated in a post-hoc analysis of patients with prominent
negative symptoms.[4] Patients with prominent negative symptoms at
baseline were identified as having a Positive and Negative Syndrome
Scale (PANSS) negative subscale score greater than or equal to25
(median score) and a PANSS positive score <25 (median score).[4] The
analysis showed that Latuda treatment in the prominent negative
symptom group was associated with significantly greater week six
improvement compared to placebo on the PANSS-negative subscale score
(-6.3 vs -4.5; p<0.01).[4] Treatment with Latuda was well-tolerated
in the prominent negative symptom group with relatively low
discontinuation rates due to adverse events.[4]

Abstract [P.3.d.058]: 'Maintenance efficacy of lurasidone compared
to higher doses of quetiapine XR in schizophrenia: results from a
post hoc analysis'

A 12-month blinded, controlled study of Latuda vs quetiapine XR in
adult patients with schizophrenia demonstrated Latuda was
non-inferior to quetiapine XR in prevention of relapse.[5] In this
post-hoc analysis, the maintenance efficacy of Latuda (37-148 mg/day)
was compared to higher doses of quetiapine XR (600-800 mg/day).[5]
The results of a Kaplan-Meier analysis showed that when compared to
quetiapine XR, the probability of relapse was 23.7% for subjects
receiving Latuda and 33.6% for quetiapine XR.[5] In this analysis,
the remission rates, based on full Remission in Schizophrenia Working
Group (RSWG) criteria requiring improvement for at least 6 months,
were 61.9% for Latuda and 46.8% for quetiapine XR (p=0.056).[5]

"Schizophrenia is a condition that can have a devastating impact
on people's lives. Both patients and their healthcare providers need
a broader range of effective treatment choices to help better manage
schizophrenia; these latest data further support the proven efficacy
of Latuda in both the short and long-term treatment of adult patients
with schizophrenia. Treatment with Latuda is also generally
well-tolerated and is not likely to increase the risk for
cardiometabolic disorders, which is additionally important for
patients with related co-morbidities," said Rodrigo Palma dos Reis,
M.D., Medical Director, Takeda.

In addition, new analyses of lurasidone data in adult patients
with major depressive episodes associated with bipolar I disorder
(bipolar depression) were presented.[6],[7] Lurasidone is approved
for the treatment of bipolar depression in the United States and in
Canada under the trade name Latuda. Lurasidone is not currently
approved for bipolar depression in Europe.

About Latuda(R) (lurasidone)

Latuda is an atypical antipsychotic, developed originally by
Sumitomo Dainippon Pharma Co., Ltd. It has high affinity for dopamine
D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has
antagonistic effects.[8] In addition, Latuda is a partial agonist at
the serotonin 5-HT1A receptor,[8] and has no appreciable affinity for
histamine (H1) or muscarinic (M1) receptors.[9]

The recommended starting dose of Latuda is 37 mg once daily.[10]
No initial dose titration is required.[10] It is effective in a dose
range of 37 to 148 mg once daily.[10] The Latuda Summary of Product
Characteristics includes additional dosing information for special
patient populations.

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 Sunovion Pharmaceuticals Inc.'s
subsidiary Sunovion Pharmaceuticals Canada Inc., in Switzerland in
September 2013 through Takeda and in the UK in August 2014 through
Sunovion Pharmaceuticals Europe Ltd. In Japan a Phase III clinical
study is underway for the treatment of schizophrenia by Sumitomo
Dainippon Pharma Co., Ltd.

In March 2011, Sumitomo Dainippon Pharma Co., Ltd. and Takeda
Pharmaceutical Company Limited in Japan signed a Development and
Commercialization Agreement of the oral formulation of lurasidone
hydrochloride for the joint development and exclusive
commercialization by Takeda in the 26 member states of the European
Union at that time (excluding the United Kingdom), Switzerland,
Norway, Turkey and Russia. Sunovion Pharmaceuticals Europe Ltd., a
wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc., is
commercializing Latuda in the United Kingdom.

About Schizophrenia

Schizophrenia is a severe, chronic mental illness 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] which can in part be due to the undesirable
effects of antipsychotics such as weight gain and increased blood
sugar.[13]

Antipsychotic pharmacotherapy is the cornerstone of treatment for
patients with schizophrenia, with agents generally classed as typical
or atypical.[14] Atypical agents are broadly considered to have
tolerability benefits over typical agents.[14] Switching
antipsychotic medication is common in the treatment of patients with
schizophrenia either due to residual or emergent symptoms, adverse
events or tolerability issues.[15],[16]

Direct and indirect costs associated with caring for patients with
schizophrenia are considerable and can include utilisation of other
health services, pharmacotherapy, community care, supportive therapy,
informal care and private expenditures, and patient and caregiver
lost productivity.[17],[18]Hospitalization associated with patient
relapse can significantly increase costs associated with disease
management in schizophrenia.[19]

About Takeda Pharmaceuticals International GmbH

Headquartered in Zurich as a subsidiary of Takeda Pharmaceutical
Company Limited, Osaka, Japan, the company 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. Areas of focus include
cardiovascular and metabolic, oncology, respiratory and immunology,
central nervous system, general medicine, and vaccines.

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. Through strategic acquisitions, Takeda has
been transforming itself, broadening its therapeutic expertise and
geographic outreach.

Additional information about Takeda is available through its
corporate website, http://www.takeda.com.

About Sunovion Pharmaceuticals Inc. Sunovion Pharmaceuticals Inc.,
an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma, is
headquartered in Marlborough, Mass. Sunovion is a leading
pharmaceutical company dedicated to discovering, developing and
commercialising therapeutic products that advance the science of
medicine and improve the lives of patients and their families. More
information about Sunovion Pharmaceuticals Inc. is available at
http://www.sunovion.com
[http://c/Users/apikalov/AppData/Local/Microsoft/Windows/Temporary
InternetFiles/koneill/Downloads/www.sunovion.com ] .

References

1. Newcomer MD et al. Effect of lurasidone or risperidone on
metabolic syndrome status in patients with schizophrenia: a post hoc
analysis of a long-term study. Poster presented at ECNP, Berlin, 2014

2. Mattingly GW et al. An open-label extension study of lurasidone
in patients with schizophrenia previously randomized to lurasidone or
risperidone. Poster presented at ECNP, Berlin, 2014

3. Loebel AD et al. Evaluation of daytime sleepiness in patients
with schizophrenia treated with atypical antipsychotics. Poster
presented at ECNP, Berlin, 2014

4. Schooler NR et al. Efficacy of Lurasidone in the Treatment of
Schizophrenia With Prominent Negative Symptoms: A Post-Hoc Analysis
of Five Short-Term Trials. Poster presented at ECNP, Berlin, 2014

5. Sacchetti E et al. Maintenance efficacy of lurasidone compared
to higher-doses of quetiapine XR in schizophrenia: results from a
post-hoc analysis. Poster presented at ECNP, Berlin, 2014

6. Thase ME et al. Lurasidone Treatment For Bipolar I Depression:
Effect on Core Depression Symptoms. Poster presented at ECNP, Berlin,
2014

7. Ketter TA et al. Lurasidone in Bipolar I Depression: A 24 Week,
Open-label Extension Study. Poster presented at ECNP, Berlin, 2014

8. Werner P et al. In vitro receptor binding profile of lurasidone
and other commonly used Antipsychotics. Eur Neuropsychopharmacol
2012;22(Suppl 2):S349

9. Ishibashi T et al. 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;334:171-81

10. Latuda. Summary of Product Characteristics. April 2014.

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

12. Tiihonen J et al. 11-year follow-up of mortality in patients
with schizophrenia: a population-based cohort study (FIN11 study).
Lancet 2009; 374:620-7

13. De Hert M et al. Metabolic and cardiovascular adverse effects
associated with antipsychotic drugs. Nat Rev Endocrinol
2012;8:114-26.

14. Lewis DA and Lieberman JA. Catching Up on Schizophrenia:
Review Natural History and Neurobiology. Neuron 2000;28:325-34

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

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

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

18. Mangalore R et al. Cost of schizophrenia in England. J Ment
Health Policy Econ 2007; 10(1): 23-41

19. 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

Media Contacts
Patrick Gaffey
Corporate Communications
Sunovion Pharmaceuticals Inc.
+1-508-357-7500
patrick.gaffey@sunovion.com

Elissa Johnsen
Director, Product Communications
Takeda Pharmaceuticals
+1-224-554-3185
elissa.johnsen@takeda.com

Date of preparation: October 2014

Job number: EUCAN/LUR/2014-10043

ots Originaltext: Takeda Pharmaceuticals International GmbH and Sunovion Pharmaceuticals Inc.
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