HIGHLIGHTS OF RECENT PROGRESS
Albuferon(R): On Track with Timeline to Phase 3 Data and Filing of Marketing Applications
On November 1, 2007, HGS announced that it completed enrollment ahead of schedule in ACHIEVE 2/3, the second of two pivotal Phase 3 clinical trials of Albuferon (albinterferon alfa-2b) in combination with ribavirin in treatment- naive patients with chronic hepatitis C. Enrollment in ACHIEVE 1 was also completed ahead of schedule, in August 2007. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
On January 23, 2008, HGS announced the modification of dosing in one arm of each of its ACHIEVE clinical trials based on recommendations made by the studies' independent Data Monitoring Committee (DMC). Patients in the Phase 3 trials who had been receiving the 1200-mcg dose are now receiving the 900-mcg dose, which HGS has viewed for some time as the dose of Albuferon most likely to be marketed. Consistent with its charter, the DMC will continue to review all adverse events on an ongoing basis as the ACHIEVE trials move forward.
The final results of Phase 2 trials of Albuferon were presented at the annual meeting of the American Association for the Study of Liver Diseases in November 2007. These results suggest that the 900-mcg dose of Albuferon every two weeks demonstrated efficacy and safety comparable to Pegasys, with half the injections, improvements in quality of life and fewer missed days of work on treatment. If these results are confirmed in Phase 3, HGS believes that Albuferon could become the market-leading interferon for the treatment of hepatitis C.
|SOURCE Human Genome Sciences, Inc.|
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