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Regulatory update - Benlysta® (belimumab)

GlaxoSmithKline PLC (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. The submission was made in collaboration with Human Genome Sciences, Inc (HGS). Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.

Issued: London UK

GlaxoSmithKline PLC (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. The submission was made in collaboration with Human Genome Sciences, Inc (HGS). Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.

HGS anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for belimumab, by the end of June 2010.

Belimumab is not approved or licensed anywhere in the world.

GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.

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:

Philip Thomson

(020) 8047 5502

 

Claire Brough

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

(020) 8047 5502

 

Jo Revill

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(919) 483 2839

 

   

European Analyst/Investor enquiries:

David Mawdsley

(020) 8047 5564

 

Sally Ferguson

(020) 8047 5543

 

Gary Davies

(020) 8047 5503

     

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

 

Jen Hill Baxter

(215) 751 7002

Benlysta is a trademark of Human Genome Sciences, Inc.