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ViiV Healthcare announces regulatory submissions for dolutegravir in the EU, US and Canada
 
 
  London, UK - 17 December, 2012 ViiV Healthcare today announced the submission of regulatory applications in the European Union (EU), United States (US) and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment ofHIV infection in adults and adolescents, specifically:
 
· A Marketing Authorisation Application to the European Medicines Agency for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.
 
· A New Drug Application to the US Food and Drug Administration for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.
 
· A New Drug Submission to Health Canada for dolutegravir for the treatment ofHIV infection in adults and children aged 12 years and older.
 
"These regulatory submissions are an important step for ViiV Healthcare, representing our commitment as a company to bring new treatments to people living with HIV." said John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare. "We are encouraged by the comprehensive data package supporting dolutegravir, and believe that it has the potential to offer an important new option for the treatment of both nave and treatment-experienced patients with HIV."
 
About ViiV Healthcare
 
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visitwww.viivhealthcare.com.
 
ViiV UK/US Media enquiries: Camilla Bull +44 (0) 20 8380 6226
Marc Meachem +1 919 483 8756
GSK Global Media enquiries: David Daley +44 (0) 20 8047 5502
Eleanor Bunch +44 (0) 20 8047 5502
 
GSK Analyst/Investor enquiries: Sally Ferguson +44 (0) 20 8047 5543
Lucy Budd +44 (0) 20 8047 2248
Tom Curry + 1 215 751 5419
Gary Davies + 44 (0) 20 8047 5503
James Dodwell + 44 (0) 20 8047 2406
Jeff McLaughlin + 1 215 751 7002
Ziba Shamsi + 44 (0) 20 8047 3289
 
 
 
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