Sunovion Pharmaceuticals Europe Ltd. and NewBridge Pharmaceuticals Announce Agreement for Distribution of Latuda® (lurasidone) in the Gulf Cooperation Council Region

Date: November 30, 2016

Sunovion Pharmaceuticals Europe Ltd. (Sunovion) and NewBridge Pharmaceuticals (NewBridge) have signed a distribution agreement to make Latuda® (lurasidone), an atypical antipsychotic, available in the six countries of the Gulf Cooperation Council (GCC) Region. The GCC is composed of Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman.
Under this exclusive agreement, NewBridge, based in Dubai, will work closely with Sunovion to seek Marketing Authorisations for lurasidone for the treatment of schizophrenia in adults aged 18 years and over in the GCC Region. Following a successful Marketing Authorisation application NewBridge will then take responsibility for the distribution, sales and promotion of lurasidone across the Region.
“As a global company dedicated to helping address unmet medical needs, Sunovion is proud to partner with NewBridge to make lurasidone available to prescribers in the GCC Region as a treatment option for adult patients living with schizophrenia,” said Terry Petersen, General Manager, Europe, Sunovion Pharmaceuticals Europe Ltd. 
‘‘We are delighted to work in partnership with Sunovion to ensure that lurasidone is made available for adult patients living with schizophrenia across the region. We strive to increase the accessibility of innovative medicines such as lurasidone in the region.” said Joe Henein, President & CEO, NewBridge Pharmaceuticals.
LATUDA is licenced in the EU for the treatment of schizophrenia in adults aged 18 years and over.
Please find links to the LATUDA Summary of Product Characteristics (SmPC) http://www.sunovion.eu/files/LATUDACombinedSmPC.pdf
NOTE:
In the EU, LATUDA carries a black triangle q to denote additional monitoring is required in relation to adverse reactions. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to the Competent Authority in their country. Adverse reactions should also be reported to Sunovion Pharmaceuticals Europe Ltd. on +44207 821 2899
 
About Latuda® (lurasidone)
LATUDA is an atypical antipsychotic, developed originally by Sumitomo Dainippon Pharma Co., Ltd. with a high affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonistic effects1. In addition, LATUDA is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine (H1) or muscarinic (M1) receptors1.
LATUDA is a once daily, oral antipsychotic indicated for the treatment of schizophrenia in adults 18 years and over. 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 daily2
For more information about LATUDA, please visit www.latuda.co.uk.
About Sunovion
Sunovion Pharmaceuticals Europe, headquartered in London, is a wholly owned subsidiary of Sunovion Pharmaceuticals Inc. Additional information about Sunovion Pharmaceuticals Europe is available on the company’s website 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 global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Additional information can be found on the company’s website www.sunovion.com
LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
About NewBridge
NewBridge Pharmaceuticals, headquartered in Dubai, United Arab Emirates, is a regional specialty company providing a one-stop-solution to pharmaceuticals, biological, genomics and other innovative healthcare companies wanting to have access to the emerging markets of the Middle East & Africa region.
For more information, please visit www.nbpharma.aratech.co
For any media inquiries, contact:
Patrick Gaffey
Sunovion Pharmaceuticals Inc.
Executive Director, Corporate Communications
508-787-4565
[email protected]
 
References
1. Nakamura M et al. Lurasidone in the Treatment of Acute Schizophrenia: A Double-Blind, Placebo-Controlled Trial. J Clin Psychiatry 2009;70:829–36
2. Latuda. Summary of Product Characteristics. 2016
 
© 2016 Sunovion Pharmaceuticals Inc.