Sunovion Pharmaceuticals Europe Ltd

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

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

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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