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www.fdanews.com/articles/89273-hgs-begins-trial-of-albuferon-in-genotype-2-and-3-hepatitis-c

HGS BEGINS TRIAL OF ALBUFERON IN GENOTYPE 2 AND 3 HEPATITIS C

March 6, 2007

Human Genome Sciences (HGS) has initiated dosing in ACHIEVE 2/3, a Phase III clinical trial of Albuferon in combination with ribavirin in treatment-naive patients with chronic hepatitis C genotypes 2 and 3.

ACHIEVE 2/3 is the second of two pivotal Phase III trials of Albuferon (albinterferon alfa-2b) that HGS is conducting, with the goal of filing global marketing applications in 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement.

Both studies are randomized, open-label, active-controlled, multicenter, noninferiority trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon plus ribavirin compared with PEGASYS (peginterferon alfa-2a) plus ribavirin. HGS initiated dosing in ACHIEVE 1, a Phase III trial of Albuferon in treatment-naive patients with chronic hepatitis C genotype 1, in December 2006.

Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using its proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, according to the company. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins.