BENLYSTA is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS®, which was discovered by HGS. In lupus, rheumatoid arthritis 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. Two pivotal Phase 3 clinical trials of BENLYSTA in patients with systemic lupus erythematosus (SLE) are now nearing completion: BLISS-76 and BLISS-52. The design of the two trials is similar, except for the duration of therapy, which will be 52 weeks in BLISS-52 and 76 weeks in BLISS-76. The primary efficacy endpoint of both trials is the patient response rate at Week 52. BLISS-52 results are expected in July 2009, and results from BLISS-76 are expected in November 2009. Assuming success in Phase 3, HGS believes that BENLYSTA could become a breakthrough treatment for SLE. BENLYSTA is being developed by HGS and GlaxoSmithKline (GSK) under a definitive worldwide co-development and commercialization agreement entered into in August 2006.

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