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Human Genome Sciences Announces Fourth-Quarter and Full-Year 2008 Financial Results and Key Developments
Date:2/26/2009

rax. The Company expects to receive at least $150 million from this sale in 2009, with most of the revenue expected in the first quarter. ABthrax is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS). Also under the contract, the Company plans to file a Biologics License Application (BLA) with the FDA in the second quarter of 2009. HGS will receive an additional $15 million from the U.S. Government upon FDA licensure of ABthrax.

Albuferon(R): Positive Data Announced for First of Two Phase 3 Trials in Chronic Hepatitis C Patients; Results of Second Phase 3 Trial Expected in March 2009

In December 2008, HGS reported that Albuferon (albinterferon alfa-2b) met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in ACHIEVE 2/3, the Phase 3 clinical trial of Albuferon in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. The data showed that the rate of sustained virologic response was comparable for the 900-mcg dose of Albuferon administered every two weeks, vs. the standard 180-mcg dose of peginterferon alfa-2a administered once weekly. Rates of serious adverse events, severe adverse events and discontinuations due to adverse events were also comparable. ACHIEVE 1, the second Albuferon Phase 3 clinical trial, is being conducted in treatment-naive patients with genotype 1 chronic hepatitis C; data are expected in March 2009. Assuming success in Phase 3, HGS expects that global marketing applications will be filed in fall 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.

LymphoStat-B(R): Phase 3 Results Expected in July and November 2009


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SOURCE Human Genome Sciences, Inc.
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