Human Genome Sciences, Inc (HGS) announced that Albuferon (albinterferon alfa-2b) met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in Achieve 1, a phase-3 clinical trial of Albuferon in combination with ribavirin in treatment-naive patients with genotype-1 chronic hepatitis C (p=0.0008). Albinterferon alfa-2b is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.

"These phase-3 data show that, with half the injections, the efficacy of Albuferon was comparable to Pegasys," said H Thomas Watkins, president and chief executive officer, HGS. "We are pleased that Albuferon met its primary endpoint in the Achieve 1 trial as it also did in Achieve 2/3. We look forward to the filing of global marketing applications in fall 2009, following discussions with regulatory authorities. Assuming licensure, we believe Albuferon could become a market-leading treatment for chronic hepatitis C."

Stefan Zeuzem, professor of Medicine and chief, Department of Medicine, J W Goethe University Hospital, Frankfurt, Germany, said, "These phase-3 results in patients infected with the genotype-1 virus, evaluated together with the previously reported phase-3 results in patients infected with the genotypes-2 and 3 viruses, suggest that albinterferon alfa-2b has the potential to become an important new treatment option for chronic hepatitis C."

"We are encouraged that albinterferon alfa-2b met the primary efficacy endpoint of non-inferiority to peginterferon alfa-2a in both of our pivotal phase-3 studies," said David C. Stump, executive vice president, Research and Development, HGS. "As we found with the earlier results from Achieve 2/3, the Achieve 1 data show that the rate of sustained virologic response was comparable for the treatment group receiving the 900-mcg dose of albinterferon alfa-2b every two weeks, versus the treatment group receiving the standard dose of peginterferon alfa-2a once weekly. Importantly, the rate of serious and/or severe adverse events was also comparable for these treatment groups. We were pleased to see that serious pulmonary adverse events in the 900-mcg group were infrequent and all resolved with cessation of treatment."

Albinterferon alfa-2b is a genetic fusion of human albumin and interferon alfa created using the proprietary HGS albumin-fusion technology.

The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.