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Sunovion Pharmaceuticals Europe Ltd. to Present New Data on LATUDA® ? (lurasidone) at the 23rd European Congress of Psychiatry

Geschrieben am 30-03-2015

Vienna (ots/PRNewswire) -

Sunovion Pharmaceuticals Europe Ltd. will present 10 new research
posters on LATUDA(R) (lurasidone), an atypical antipsychotic
treatment for adults with schizophrenia, at the 23rd European
Congress of Psychiatry (EPA). The meeting will be held 28-31 March
2015 in Vienna, Austria.

"We are pleased to be presenting new data from clinical studies,
including data and analyses from the schizophrenia and bipolar
depression clinical trial programs, as part of our ongoing commitment
to increasing understanding of LATUDA among the European psychiatric
research community," said Antony Loebel, M.D., Executive Vice
President and Chief Medical Officer, Sunovion Pharmaceuticals Inc.

Following is a summary of the LATUDA presentations sponsored by
Sunovion:

- 1139: Effects of Lurasidone on Hostility in Patients with an
Acute Exacerbation of Schizophrenia: A Pooled Post-Hoc Analysis of 5
Short-Term Studies (Oral Presentation on Tuesday 31 March from
15:27-15:36 in Hall L8)

- Authors: Leslie Citrome, M.D., Ph.D., Andrei Pikalov, M.D.,
Ph.D., Michael Tocco, Ph.D., Jay Hsu, Ph.D., Antony Loebel, M.D.

- 0830: Efficacy and Safety of Long-Term Treatment with Lurasidone
in Older Adults with Bipolar Depression: Results of a 6 Month
Open-Label Study (ePoster)

- Authors: Brent Forester, M.D., Martha Sajatovic, M.D., Joyce
Tsai, Ph.D., Hans Kroger, M.P.H., Andrei Pikalov, M.D., Ph.D.,
Josephine Cucchiaro, Ph.D., Antony Loebel, M.D.

- 0834: Efficacy and Safety of Lurasidone in Older Adults with
Bipolar Depression: Analysis of Two Double-Blind, Placebo-Controlled
Studies (ePoster)

- Authors: Martha Sajatovic, M.D., Brent Forester, M.D., MSc.,
Joyce Tsai, Ph.D., Hans Kroger, M.P.H., Andrei Pikalov, M.D., Ph.D,
Josephine Cucchiaro, Ph.D., Antony Loebel, M.D.

- 0905: Cost-Utility Analysis of Lurasidone versus Aripiprazole in
Adults with Schizophrenia in Scotland (ePoster)

- Authors: Krithika Rajagopalan, Ph.D., Francesca L. Crowe, Ph.D.,
David Trueman, MSc., Andrei Pikalov, M.D., Ph.D., Antony Loebel, M.D.

- 0920: Effect of Lurasidone on Metabolic Parameters in Patients
with Bipolar Depression (ePoster)

- Authors: John Newcomer, M.D., Joyce Tsai, Ph.D., Andrei Pikalov,
M.D., Ph.D., Hans Kroger, M.P.H., Josephine Cucchiaro, Ph.D., Antony
Loebel, M.D.

- 0923: Optimizing Treatment with Lurasidone in Patients with
Schizophrenia: Results of a Randomized, Double-Blind,
Placebo-Controlled Study (ePoster)

- Authors: Antony Loebel, M.D., Robert Silva, Ph.D., Robert
Goldman, M.D., Kei Watabe, M.S., Andrei Pikalov, M.D., Ph.D.,
Josephine Cucchiaro, Ph.D., John M. Kane, M.D.

- 1006: Symptomatic and Functional Remission and Recovery in
Lurasidone-Treated Patients with Bipolar I Depression (ePoster)

- Authors: Antony Loebel, M.D., Cynthia O. Siu, Ph.D., Krithika
Rajagopalan, Ph.D., Andrei Pikalov, M.D., Ph.D., Josephine Cucchiaro,
Ph.D., Terence A. Ketter, M.D.

- 1111: Pharmacokinetic and Safety Evaluation of Lurasidone in
Pediatric Patients with Psychiatric Disorders (ePoster)

- Authors: Robert Findling, M.D., M.B.A., Yu-Yuan Chiu, Ph.D.,
Robert Silva, Ph.D., Robert Goldman, Ph.D., Fengbin Jin, Ph.D.,
Andrei Pikalov, M.D., Ph.D., Antony Loebel, M.D.

- 1721: Lurasidone and Sexual Dysfunction: Post-Hoc Analysis of
Pooled Data (ePoster)

- Authors: Rodrigo Palma dos Reis, M.D., Henrik Andersson, MSc.,
Venkatesh Murthy, M.D., Ph.D.

- 1723: Long-Term Lurasidone Treatment is Not Associated with
Clinically Significant Increases in Prolactin- or
Hyperprolactinaemia-Related Adverse Events: A Post-Hoc Analysis
(ePoster)

- Authors: Amir Inamdar, MBBS, Boadie W. Dunlop, M.D., Rodrigo
Palma dos Reis, M.D., Henrik Andersson, MSc., Venkatesh Murthy, M.D.,
Ph.D.

The marketing authorisation for LATUDA in the EU was based on
short- and long-term data, which found LATUDA to be effective in
treating adult patients with schizophrenia.[1]
,[2],[3],[4],[5],[6],[7] LATUDA is not indicated in the EU for the
treatment of bipolar depression.

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can help by
reporting any side effects. See http://www.mhra.gov.uk/yellowcard for
how to report side effects. Please find links to the LATUDA Summary
of Product Characteristics (SmPC) and the Prescribing Information at
http://www.medicines.org.uk/emc/medicine/29125 and
http://latuda.co.uk/prescribing-information/.

NOTES TO EDITORS:

In the UK the Commission on Human Medicines (CHM) and the
Medicines and Healthcare Products Regulatory Agency (MHRA) encourage
the reporting of all suspected adverse reactions (side effects) to
newer drugs and vaccines, which are denoted by an inverted,
equilateral black triangle (Black Triangle Drug). LATUDA carries a
black triangle to denote additional monitoring is required in
relation to adverse reactions. You can help by reporting any side
effects you may get. See http://www.mhra.gov.uk/yellowcard for how to
report side effects. Please find links to the LATUDA Summary of
Product Characteristics (SmPC) and the Prescribing Information at
http://www.medicines.org.uk/emc/medicine/29125 and
http://latuda.co.uk/prescribing-information/.

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 (full
antagonist).[10] In addition, LATUDA is a partial agonist at the
serotonin 5-HT1A receptor and has no appreciable affinity for
histamine (H1) or muscarinic (M1) receptors.[3]

The recommended starting dose of LATUDA is 37 mg once-daily with a
meal. No initial dose titration is required. It is effective in a
dose range of 37-148 mg once-daily.[8]

LATUDA was approved for the treatment of schizophrenia in adults
in the US in October 2010, in Canada in June 2012, in Switzerland in
August 2013, in Australia in March 2014 and in the EU in March 2014.
LATUDA is available in Switzerland, Norway, Finland, the Netherlands
and the UK. Outside of Europe, LATUDA is available in the US and
Canada.

For more information about LATUDA, please visit
http://www.latuda.co.uk.

About Schizophrenia

Schizophrenia is a severe, chronic mental condition that can
affect both men and women.[9] Patients with schizophrenia have a life
span that is decreased by approximately 10-22.5 years compared with
the general population.[10],[11]

Antipsychotic pharmacotherapy is the cornerstone of treatment for
patients with schizophrenia, with agents classified as typical or
atypical. Atypical agents are broadly considered to have tolerability
benefits over typical agents.[12] Switching antipsychotic medication
is common in the treatment of patients with schizophrenia either due
to residual or emergent symptoms, adverse events or tolerability
issues.[13]

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.[14],[15] Hospitalisation associated with patient
relapse significantly increases costs associated with disease
management in schizophrenia.[16]

About Sunovion Pharmaceuticals Europe Ltd.

Sunovion Pharmaceuticals Europe, headquartered in London, UK, is a
wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc.
Additional information about Sunovion Europe is available at
http://www.sunovion.eu.

Sunovion Pharmaceuticals Inc., an indirect, wholly-owned
subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is headquartered
in Marlborough, Massachusetts, US. 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.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical
company in Japan. Sumitomo Dainippon Pharma aims to produce
innovative pharmaceutical products in the Psychiatry & Neurology area
and the Oncology area, which have been designated as the focus
therapeutic areas. Sumitomo Dainippon Pharma is based on the merger
in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about
7,000 employees worldwide. Additional information about Sumitomo
Dainippon Pharma is available through its corporate website at
http://www.ds-pharma.com.

LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co.,
Ltd.

Sunovion Pharmaceuticals Inc. is a US subsidiary of Sumitomo
Dainippon Pharma Co., Ltd.

(c) 2015 Sunovion Pharmaceuticals Inc.

For a copy of this release, visit the Sunovion web site at

http://www.sunovion.com

References

1. 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

2. Loebel A et al. Ef?cacy and safety of lurasidone 80 mg/day and
160 mg/day in the treatment of schizophrenia: A randomized,
double-blind, placebo- and active-controlled trial. Schizophr Res
2013; 145:101-109

3. Nakamura M et al. Lurasidone in the Treatment of Acute
Schizophrenia: A Double-Blind, Placebo-Controlled Trial. J Clin
Psychiatry 2009;70:829-36

4. Ogasa M et al. Lurasidone in the treatment of schizophrenia: a
6-week, placebo-controlled study. Psychopharmacol [Berl]
2013;225(3):519-30

5. Loebel A et al. Effectiveness of lurasidone vs. quetiapine XR
for relapse prevention in schizophrenia: A 12-month, double-blind,
non-inferiority study. Schizophr Res. 2013; (147) 95-102

6. Nasrallah H.A., et al. Lurasidone for the treatment of acutely
psychotic patients with schizophrenia: a 6-week, randomised,
placebo-controlled study. J Psych Res 2013; 47:670-677

7. Stahl, S.M., et al. Effectiveness of lurasidone for patients
with schizophrenia following 6 weeks of acute treatment with
lurasidone, olanzapine, or placebo: A 6-month, open- label, extension
study. J Clin Psychiatry 2013

8. Latuda. Summary of Product Characteristics. 2014

9. National Institute of Mental Health. What is Schizophrenia?
Available at:
http://www.nimh.nih.gov/health/publications/schizophrenia/index.shtml
Last accessed: July 2014

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

11. 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

12. Lewis DA and Lieberman JA. Catching up on schizophrenia:
Review natural history and neurobiology. Neuron 2000;28:325-34

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

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

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

16. 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: Sunovion Pharmaceuticals Europe Ltd
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Hannah Russell / Claire Grindal, Red Door
Communications, Phone: +44-(0)208-392-8094/8091, Mobile:
+44-7887-643964,
Email: hrussell@rdcomms.com; Andrea Hall, Sunovion Pharmaceuticals
Europe
Ltd., Phone: +44-207-821-2848, Email: andrea.hall@sunovion.eu


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