BENLYSTA is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS®, which was discovered by HGS in 1997. BENLYSTA is being developed by HGS and GlaxoSmithKline under a co-development and commercialization agreement entered into in August 2006. 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.

BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). The efficacy of treatment with BENLYSTA plus standard of care was superior to placebo plus standard of care in both BLISS-52 and BLISS-76, with overall adverse event rates comparable to placebo plus standard of care. Following discussions with regulatory authorities, the submission of marketing applications is planned in the United States, Europe and other regions in the first half of 2010. HGS believes BENLYSTA has the potential to become the first new approved drug for people living with lupus in more than 50 years.

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