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UPDATE 2-Human Genome hep C drug shows promise in mid stage
March 24, 2010 / 11:56 AM / in 8 years

UPDATE 2-Human Genome hep C drug shows promise in mid stage

* Hepatitis C drug Zalbin compares to Roche’s Pegasys

* Says Zalbin showed efficacy, safety comparable with Pegasys (Adds details, stock movement)

March 24 (Reuters) - 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 Chaudhuri)

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