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Issued: London, UK & Philadelphia, US

GlaxoSmithKline (NYSE: GSK) today announced the results of a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA). When asked if the dutasteride risk/benefit profile is favorable for reduction in the risk of prostate cancer in this target population, the ODAC voted 14 against, 2 in favor, and 2 abstentions.

“Whilst we are disappointed by the Committee’s conclusions on dutasteride as a prostate-cancer risk-reduction therapy, it is important to note that dutasteride has an established efficacy and safety profile in the treatment of BPH, including trials involving 10,000 men and the cumulative of 5.5 million years of patient exposure,” said Anne Phillips, MD, vice president, medicine development leader, Oncology Research and Development, GlaxoSmithKline. “We will continue to work with the FDA on the review of the sNDA.”

For more information about dutasteride, please see the full prescribing information at www.gsk.com.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

GlaxoSmithKline enquiries:

   

UK Media enquiries:

David Mawdsley

(020) 8047 5502

 

Claire Brough

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

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Jo Revill

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Jennifer Armstrong

(919) 483 2839

 

   

European Analyst/Investor enquiries:

Sally Ferguson

(020) 8047 5543

 

Gary Davies

(020) 8047 5503

 

Ziba Shamsi

(020) 8047 3289

     

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

 

Jen Hill Baxter

(215) 751 7002

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