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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

proved by regulatory authorities in more than 50 years. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

"Lupus is a chronic, often debilitating, and sometimes fatal illness that affects an estimated five million people worldwide and can have a devastating effect on both patients living with the disease and their families," said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. "BENLYSTA is the first medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially important therapeutic advance to patients suffering from SLE."

Key Findings from BLISS-52

"The BLISS-52 results support and extend the findings that emerged in the serologically active subgroup of SLE patients at Week 52 in our Phase 2 trial," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We are delighted to report that the efficacy of treatment with BENLYSTA plus standard of care was superior in this study to that of placebo plus standard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including SELENA SLEDAI and Physician's Global Assessment. Of note, a greater percentage of patients receiving BENLYSTA achieved a clinically meaningful reduction in steroid dose. We hope to have a full presentation of BLISS-52 results at an appropriate scientific meeting later in 2009."

    Topline BLISS-52 results include:
     -- Based on an intention-to-treat (ITT) analysis, belimumab met its
         
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SOURCE  Human Genome Sciences, Inc.
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