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Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus
Date:6/11/2009

o worsening in Physician's Global Assessment. This response rate is the primary efficacy endpoint in the ongoing pivotal Phase 3 clinical trials.

About BENLYSTA (belimumab)

BENLYSTA is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(R). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrate that BLyS antagonists can reduce autoantibody levels and help control autoimmune disease activity.

About the Collaboration with GSK

In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the BENLYSTA Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately 1.5 million people in the United States and approximately 5 million worldwide suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common
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SOURCE Human Genome Sciences, Inc.
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