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ABthrax(TM): Awaiting U.S. Government Authorization to Begin Delivery to Strategic National Stockpile
HGS is currently awaiting U.S. Government authorization to begin delivery of 20,000 doses of ABthrax (raxibacumab) to the Strategic National Stockpile. ABthrax is being developed under contract with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS). HGS has met every milestone under its contract and previously expected that authorization would be received and delivery to the stockpile would commence in fall 2008 - in time to enable HGS to recognize $100-120 million in ABthrax sales in the fourth quarter of 2008. It now appears likely that these sales may instead be recognized in 2009, and the Company is updating its 2008 financial guidance accordingly. HGS is confident that it will receive $150 million in 2009 for delivery of 20,000 doses of ABthrax to the U.S. Strategic National Stockpile, with an additional $15 million expected upon FDA licensure.
Enrollment and Initial Dosing Completed in Non-Small Cell Lung Cancer Trial
In August 2008, HGS completed the enrollment and initial dosing of
patients in a randomized Phase 2 trial of HGS-ETR1 (mapatumumab) in
combination with the chemotherapy agents paclitaxel and carboplatin as
first- line therapy in advanced non-small cell lung cancer (NSCLC). HGS
expects initial data from this study in 2009. The results of the NSCLC
trial, along with the results of ongoing randomized Phase 2 studies of
HGS-ETR1 in advanced hepatocellular cancer and advanced multiple myeloma,
will support a decision on whether to advance HGS-ETR1 t
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| SOURCE Human Genome Sciences, Inc. Copyright©2008 PR Newswire. All rights reserved |