- Trial conducted by Novartis evaluating safety and efficacy of Albuferon administered every four weeks in combination with ribavirin in patients with genotypes 2 and 3 hepatitis C -

ROCKVILLE, Md., June 19 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that Novartis has completed enrollment and initial dosing in a Phase 2b clinical trial to evaluate the safety and efficacy of Albuferon(R) (albinterferon alfa-2b) administered monthly in combination with ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.

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'It is estimated that approximately 170 million people worldwide are infected with hepatitis C virus, including nearly four million in the United States,' said Stephen Pianko, M.D., F.R.A.C.P., Ph.D., Monash University, Melbourne, Australia. 'Even In developed countries, fewer than half of those who have been diagnosed with chronic hepatitis C have undertaken treatment - in part due to the side effects associated with interferon injections, which are currently required on a weekly basis. A monthly dosing schedule with Albuferon may well result in more patients choosing to be treated.'

Mani Subramanian, M.D., Ph.D., Executive Director, Clinical Research - Infectious Diseases, HGS, said, 'Novartis has made excellent progress in advancing the study of albinterferon alfa-2b dosed every four weeks. This dosing regimen of albinterferon alfa-2b, with a total of six injections, could offer an important treatment option if it demonstrates safety and efficacy comparable to peginterferon alfa-2a dosed once every week with a total of 24 injections.'

About the Design of the Phase 2b Monthly Dosing Trial

This Phase 2b trial is a randomized, open-label, multi-center, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alfa-2b administered every four weeks plus daily ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. 391 patients were randomized in a 4:4:4:3 ratio into four treatment groups, including three that will receive albinterferon alfa-2b administered once every four weeks (900 mcg, 1200 mcg or 1500 mcg), in addition to the active-control group, which will receive peginterferon alfa-2a at the standard 180-mcg dose once every week.