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Human Genome Sciences Reports Progress With Late-Stage Products and New Initiatives
Date:5/28/2008

ilable by spring 2009.

-- Planned filing of global marketing authorization applications by fall

2009.

Also in 2008, Novartis plans to initiate a Phase 2 trial to evaluate monthly dosing of Albuferon in treatment-nave patients with genotypes 2 and 3 chronic hepatitis C.

LymphoStat-B(R) (belimumab), a human monoclonal antibody that neutralizes BLyS(TM) (B-lymphocyte stimulator), for the treatment of systemic lupus erythematosus SLE

In November 2007, Phase 2 results were presented at the Annual Scientific Meeting of the American College of Rheumatology, which demonstrated that LymphoStat-B achieved a sustained improvement in disease activity across multiple clinical measures, decreased the frequency of disease flares over time, and was generally well tolerated through 2.5 years on treatment in combination with standard of care in patients with active SLE. The results through 2.5 years confirm and extend the data presented at previous scientific meetings at earlier time points, including a significant reduction in SLE disease activity as measured by the response rate chosen as the primary efficacy endpoint of the Phase 3 trials. LymphoStat-B is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

Recent progress: In April 2008, HGS completed enrollment and initial dosing in BLISS-52, one of two pivotal Phase 3 clinical trials of LymphoStat-B in patients with active SLE. Completion of enrollment for the other pivotal Phase 3 trial, BLISS-76, is expected by the end of summer 2008. The LymphoStat-B BLISS program is the only Phase 3 program in SLE with a protocol design informed by prior randomized data.

Today's therapy for SLE patients involves a variety of immunosuppressive and cytotoxic agents, with prednisone as the mainstay. These existing treatments are generally considered inadequate because of their significant side effects and their inability to adequatel
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SOURCE Human Genome Sciences, Inc.
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