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Human Genome Sciences Reports Positive Long-Term Data for LymphoStat-B in Patients With Active Systemic Lupus Erythematosus
Date:6/12/2008

rofile observed for belimumab suggest that it has the potential to play an important role in the treatment of SLE."

SLE is a chronic, life-threatening autoimmune disease. It is estimated that approximately 1.5 million people in the United States and approximately 5 million worldwide suffer from various forms of lupus, including SLE.

"At Week 52 in belimumab patients with serologically active SLE, we saw significant reductions in SLE disease activity versus placebo based on multiple measures of clinical effect, including the response rate chosen as the primary efficacy endpoint of the Phase 3 trials," said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research - Immunology, Rheumatology and Infectious Diseases. "We are encouraged by the continued improvement in these patients through three years. Belimumab could represent a significant advance in the treatment of SLE if Phase 2 results are confirmed in the Phase 3 trials that are currently ongoing."

LymphoStat-B (belimumab) is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in August 2006. The first Phase 3 data for LymphoStat-B are expected by mid- 2009, and all Phase 3 data to support regulatory filings are expected in fall 2009.

Key Findings from the Phase 2 Study Continuation Through Three Years

The data presented today at EULAR 2008 demonstrate that continued treatment with belimumab is associated with sustained improvement or stabilization of SLE disease activity in serologically active patients through three years of treatment. Belimumab decreased the frequency of SLE disease flares and reduced the need for high-dose steroids in these patients over time. The overall incidence of adverse events (in general and by system organ class), serious adverse events, infections, malignancies and laboratory abnormalities continued to decrease or stabilize from Week 52 to Week 160.

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SOURCE Human Genome Sciences, Inc.
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