Albuferon is a novel longer-acting form of interferon alpha that was created using the proprietary HGS albumin-fusion technology. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. HGS is currently conducting two pivotal Phase 3 clinical trials of Albuferon in combination with ribavirin: ACHIEVE 1 in treatment-naïve patients with genotype 1 chronic hepatitis C, and ACHIEVE 2/3 in treatment-naive patients with genotype 2 or 3 hepatitis C. ACHIEVE 1 and ACHIEVE 2/3, assuming that they are successful, will provide the pivotal data to support global marketing authorization applications for Albuferon, which HGS and Novartis expect to file in fall 2009. Albuferon requires half as many injections as Pegasys (peginterferon alfa-2a), the leading available long-acting interferon, and Phase 2 clinical results suggest that Albuferon could offer efficacy and safety comparable to Pegasys, with the potential for improved quality of life and fewer lost days of work during therapy. Assuming that Phase 2 results are confirmed in Phase 3, HGS believes that Albuferon could become the market-leading interferon in treatment regimens for chronic hepatitis C. Albuferon is being developed by HGS and Novartis under a worldwide co-development and commercialization agreement entered into in June 2006.
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