Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare ...(ing his presentation Mr. Watkins will di...),Health

LATE-STAGE PRODUCTS

Albuferon(R): Met Primary Endpoint in Phase 3 Trial in Genotypes 2 and 3 Chronic Hepatitis C; Phase 3 Results in Genotype 1 Patients Expected March 2009

In December 2008, HGS reported that the results of ACHIEVE 2/3 demonstrated that Albuferon (albinterferon alfa-2b) met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in this global Phase 3 trial in 933 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C (p=0.0086). 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. The results of ACHIEVE 1, the Phase 3 trial of Albuferon in genotype 1 chronic hepatitis C, are expected in March 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.

"The data from ACHIEVE 2/3 show that the efficacy of Albuferon was comparable to Pegasys, with half the injections," said Mr. Watkins. "If Albuferon is also successful in ACHIEVE 1, we expect that global marketing applications will be filed in fall 2009 - and we believe Albuferon could become the market-leading interferon for the treatment of chronic hepatitis C,"

In a separate press release issued this morning, HGS announced that Novartis has initiated a Phase 2b trial to evaluate the safety and efficacy of Albuferon dosed monthly in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C.

Key goals for Albuferon in 2009:

• Report
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