Regulatory update – BLA filed for Benlysta® (belimumab)

GlaxoSmithKline PLC (GSK) announced today that Human Genome Sciences, Inc. (HGS) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.

Issued: Thursday 10 June 2010, London UK

GlaxoSmithKline PLC (GSK) announced today that Human Genome Sciences, Inc. (HGS) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.

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.