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Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus
Date:7/19/2009

ab, respectively vs. placebo). -- Improvement in health-related quality of life at Week 24 as measured by the SF-36 Physical Component Summary (PCS) score was not significantly different among treatment groups. However, although not a major secondary endpoint, improvement in the SF-36 PCS score at Week 52 was significantly greater in both belimumab treatment groups (p=0.025 for 10 mg/kg and p=0.027 for 1 mg/kg belimumab, respectively vs. placebo). -- In BLISS-52, belimumab was generally well tolerated, with rates of overall adverse events, serious adverse events, infections and fatalities comparable between belimumab and placebo treatment groups. Serious infections were reported in 5.9% of patients on placebo and 6.1% of patients on belimumab. The most common adverse events were headache, arthralgia, upper respiratory tract infections, urinary tract infection and influenza, and were also comparable between belimumab and placebo treatment groups. No malignancies were reported.

Professor Sandra V. Navarra, M.D., a principal investigator and Head of Rheumatology at the University of Santo Tomas, Manila, The Philippines, said, "Given the limitations of available therapies, there is a great need for well tolerated and effective treatments for lupus. We are very encouraged by the findings of BLISS-52, and look forward to presenting these results later in the year. We also look forward to the results of BLISS-76 later this year."

About the BENLYSTA (belimumab) Phase 3 Development Program

The Phase 3 development program for belimumab includes two double-blind, placebo-controlled, multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of
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SOURCE Human Genome Sciences, Inc.
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