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Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare Conference
Date:1/12/2009

final Phase 3 data from ACHIEVE 1 in March.
  • File global marketing applications in fall.
  • LymphoStat-B(R): On Track for Phase 3 Data in July and November 2009

    In 2008, HGS completed the enrollment of both Phase 3 trials of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus (SLE). The Company expects to report the first Phase 3 data for LymphoStat-B 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 - and the only Phase 3 trials in these patients whose design was directly informed by randomized Phase 2 results. LymphoStat-B is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in August 2006.

    "If LymphoStat-B is successful in Phase 3, we expect to file marketing applications in the United States and Europe in the first half of 2010, and we believe it could become the first new drug approved by the FDA for the treatment of lupus in 50 years," said Mr. Watkins. "Patients with SLE need new treatment options; we hope to be able to help meet that need with LymphoStat-B."

    Key goals for LymphoStat-B in 2009:

    • Report Phase 3 data from BLISS-52 in July.
    • Report Phase 3 data from BLISS-76 in November.

    ABthrax(TM): Delivery of 20,000 Doses to U.S. Strategic National Stockpile Expected Early in Year; HGS Confident of Receiving $150 Million in 2009

    HGS has met every milestone to date under its contract with the U.S. Government and is currently awaiting authorization to begin delivery of 20,000 doses of ABthrax (raxibacumab) to the U.S. Strategic National Stockpile for emergency use in treating inhalation anthrax. The Com
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    SOURCE Human Genome Sciences, Inc.
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