Encouraging Data on Zalbin - Analyst Blog

Recently, Human Genome Sciences Inc. (HGSI) announced interim results on hepatitis C candidate Zalbin from a mid-stage study. The study evaluated the safety and efficacy of Zalbin. The results revealed that a monthly dose of Zalbin was as effective as a weekly dose of Roche’s (RHHBY) Pegasys (peginterferon alfa-2a), which is the current standard of care.
 
The study combined Zalbin with ribavirin in 391 treatment-naive patients infected with genotypes 2 and 3 hepatitis C. Full results from the study are expected to be presented later in the year. 

The subjects enrolled for the mid-stage study were randomized in a 4:4:4:3 ratio into four treatment groups. Patients in three groups received Zalbin, administered once a month (900 mcg, 1200 mcg or 1500 mcg). Patients in the other group received Pegasys at the standard 180-mcg dose once a week.
 
All patients in the study were treated with 800-mg daily oral ribavirin. The main goal of the mid-stage study is to show sustained virologic response (SVR) (sustained response to the drug) at week 48, or 24 weeks following the end of treatment. 

The SVR rates at week 12 for the treatment arm receiving 1500-mcg of Zalbin dosed monthly came in at 81 % as against 82 % for the group receiving Pegasys. The SVR rates for groups receiving 900-mcg and 1200-mcg of Zalbin came in at 76 % and 75 % respectively. 

The company stated further that there was no increase in serious or severe respiratory events in any Zalbin arm, compared with Pegasys. Furthermore, hematologic reductions were significantly lower in all Zalbin treatment groups. The interim results, taken 12 weeks following the end of treatment, favor the continued evaluation of Zalbin dosed every four weeks in a larger late-stage study.
 
The randomized, open-label, multi-center, active-controlled, dose-ranging 24- week study was conducted by Novartis (NVS). Zalbin (albinterferon alfa-2b) is being co-developed by Human Genome and Novartis to treat hepatitis C under a worldwide agreement entered into in 2006. The two companies have selected Zalbin as the brand name for albinterferonalfa- 2b in the United States while Joulferon is the brand name for the rest of the world. 

We remind investors that Zalbin, dosed every two weeks, is under review both in the U.S. and Europe. Human Genome expects the U.S. Food and Drug Administration (FDA) to approve the drug in the fourth quarter of 2010 (target date: October 4, 2010). We believe that Zalbin could be a significant revenue earner for the company on approval. 

Our Recommendation 

We currently have a Neutral outlook on Human Genome in the long-term implying that it will perform in line with the overall U.S. equity market over the next six to twelve months. We advise investors to retain the stock over the time period.
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