Benlysta r (belimumab) for GSK and HGS, new drug for the treatment of systemic lupus erythematosus, is included in the list of public funding in Spain.

Spain, November 2011- GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that they have received marketing resolution for Benlysta ® (belimumab) in Spain. The Interministerial Commission of prices of medicines, dependent of the Ministry of health, Social policy and equality has approved the inclusion in public funding for Benlysta ® (belimumab) 10 mg/kg as adjuvant therapy in adult patients with systemic lupus erythematosus (SLE), with autoantibodies positive, with a high degree of activity of the disease (for example)(: antiADNdc positive and low level of complement), despite the standard treatment (2).

Systemic lupus erythematosus (SLE) is a potentially fatal chronic, autoimmune, and multisystem disease that can affect vital organs. Symptoms include fatigue, pain and swelling of joints, fever, skin rash and commitment of multiple organs including kidney (3,4). Lupus affects women (5) in 90% of cases and may debut at any age, although it appears most frequently in young people between 15 and 44 years (6). It is estimated that in Spain there are nearly 40,000 affected people (7).

The goal of treatment is currently controlling the activity of the disease and minimize the resulting complications of the disease itself or treatment.(3,4)

Belimumab is the first monoclonal antibody human that inhibits the biological activity of soluble BLyS, a factor of survival of the B cell, believed that it plays an important role in the production of antibodies that attack and destroy healthy tissue of the body itself.)(5)

Collaboration of GSK and HGS

HGS and GSK belimumab are developing within the framework of an agreement for joint development and comarketing this medicine signed in 2006. Benlysta is a trademark owned by Human Genome Sciences, Inc., used under license by the Group of companies GlaxoSmithKline.

GlaxoSmithKIine (GSK), one of the companies leading global research-based pharmaceutical and health care, aims to improve the quality of life of people, making it possible that people have more vitality, feel better and live longer.

GSK Biopharm R & D are investigating new approaches to take advantage of the therapeutic potential of biological agents for the benefit of patients with autoimmune diseases.

Human Genome Sciences aims to provide new drugs to people who are fighting against serious diseases.

HGS, Human Genome Sciences and Benlysta are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are property of their respective owners.

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References

(1) Navarra S et to the. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: randomised, placebo-controlled, phase 3 trial. Lancet. 2011; 377 (9767): 721-31.

(2) GlaxoSmithKline and Human Genome Sciences. Tab technique of Benlysta ® 2011.

(3) Kalunian K, Merrill JT. Curr Med Res Opin 2009; 25: 1501-1514

(4) Berker-Merok, Nossent H. J Rheumatol 2006; 33: 1570-1577.

(5) NHS Choices – Last access 20 October 2011

(6) Lupus Foundation of America – accessed October 20, 2011

(7) Danchenko N, Satya JA, Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus. 2006; 15 (5): 308-18.