LymphoStat-B 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. HGS is currently conducting two pivotal Phase 3 clinical trials of LymphoStat-B in patients with systemic lupus erythematosus (SLE): BLISS-76 and BLISS-52. The design of the two trials is similar, except for the duration of therapy, which is 76 weeks in BLISS-76 and 52 weeks in BLISS-52. The primary efficacy endpoint of both trials is the patient response rate at Week 52. Phase 2 clinical results in patients with active SLE suggest that LymphoStat-B achieved a sustained improvement in SLE disease activity across multiple clinical measures, decreased the frequency of disease flares over time, and was well tolerated through 2.5 years on treatment in combination with standard of care. Assuming that these results are confirmed in Phase 3, HGS believes that LymphoStat-B could become a breakthrough treatment for SLE. LymphoStat-B 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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