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Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus
Date:6/11/2009

rmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, and Professor, Department of Medicine, University of Oklahoma Health Sciences Center.

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.

"We are encouraged by the sustained improvement in serologically active SLE patients treated with belimumab through four years," said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research - Immunology, Rheumatology and Infectious Diseases. "We are also encouraged by the safety data presented at EULAR. The incidence rates per 100 patient years of all adverse event categories, including serious adverse events, overall adverse events, and serious infections were similar for belimumab and placebo during the 52-week double-blind period, and remained the same or decreased over four years of continuous treatment. 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."

BENLYSTA(TM) Selected as Belimumab Brand Name; Phase 3 Results Expected in July and November 2009

HGS and GlaxoSmithKline (GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

Key Findings from the Phase 2 Study Continuation through Four Years

The data presented today at EULA
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SOURCE Human Genome Sciences, Inc.
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