* Hepatitis C drug Zalbin compares to Roche's Pegasys
* Says Zalbin showed efficacy, safety comparable with
(Adds details, stock movement)
March 24 Human Genome Sciences Inc HGSI.O
said interim data from a mid-stage study testing a
monthly-dosing version of its experimental hepatitis C
treatment, Zalbin, showed the drug's efficacy was comparable
with the current standard of care.
Human Genome and its partner Novartis AG NOVN.VX have
already submitted an application to the U.S. health regulator
for a version of Zalbin dosed every two weeks and received a
review date of Oct. 4.
The mid-stage trial was conducted by Novartis to evaluate
the safety and efficacy of Zalbin, administered monthly, in 391
treatment-naive patients with chronic hepatitis C virus.
Zalbin, also known as albinterferon alfa-2b, was compared
to Roche Holding AG's ROG.VX big-selling drug Pegasys, or
peginterferon alfa-2a, in the study.
The main goal of the trial is to show sustained virologic
response or a sustained response to the drug at week 48, or 24
weeks following the end of treatment.
Sustained response rates at week 12 for the treatment group
receiving 1500-mcg of Zalbin dosed once every four weeks were
81 percent, compared to 82 percent for the group getting
Pegasys at the standard 180-mcg dose once every week.
For groups receiving 900-mcg and 1200-mcg of Zalbin, the
response rates were 76 percent and 75 percent.
Serious adverse events with Zalbin were 4 percent for
900-mcg, 3 percent for 1200-mcg and 3 percent for 1500-mcg
doses, compared with 4 percent for Pegasys.
The two current leading interferons, Pegasys and Merck &
Co's Inc (MRK.N) Pegintron are taken intravenously once a week
for up to 48 weeks in combination with the antiviral pill
ribavirin, while Zalbin is injected every two weeks.
Human Genome shares were up 1 percent to $32.55 in
premerket trade. They had closed at $32.10 Tuesday on Nasdaq.
Novartis shares were up about 1 percent to 58.65 Swiss
francs at 12.23 GMT.
(Reporting by Esha Dey in Bangalore; Editing by Ratul Ray