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Hepatitis C drug tests encouraging to HGS

The Baltimore Sun

Human Genome Sciences Inc. reported clinical trial data yesterday showing that Albuferon, a hepatitis C drug the Rockville biotech is developing, is comparable to a current therapy and may do less damage to patients' quality of life during treatment.

It also had a benefit of particular interest in the United States, where a large percentage of patients are overweight: The drug appeared to work better in heavier people than its alternative, a drug called Pegasys made by Hoffmann-La Roche Inc.

But Albuferon, one of two drugs the company is relying on for eventual revenue, also had higher rates of patient discontinuation because of adverse events - particularly at the higher dosing levels.

Even though Albuferon requires fewer injections than Pegasys, 18 percent of the patients given 1,200 micrograms of the drug every two weeks chose to stop taking it. That compares with 6 percent in the group of people being treated weekly with Pegasys in the midstage trial involving 458 patients.

That led analyst Terence Flynn of Lazard Capital Markets to conclude that may not be enough of an improvement to differentiate it from Pegasys, which Human Genome was using as a comparison.

The company, which has yet to bring a drug to market, said it will adjust dosing levels in further tests to minimize the discontinuation rates.

Yesterday's trial results showed Albuferon worked as well as Pegasys when 900 micrograms were given once every two weeks. In that Albuferon group, working patients also reported missing fewer days of work to recover from side effects, which include severe flu-like symptoms.

At the biweekly 1,200 microgram level, Albuferon was slightly less effective than the weekly Pegasys, but it met its efficacy point 68 percent of the time in heavy patients, compared with Pegasys' 53 percent. Administered once a month at 1,200 micrograms, Albuferon was effective in 51 percent of patients, compared with Pegasys' 58 percent.

Human Genome Sciences shares closed down 63 cents, or 6 percent, to $9.83 on the Nasdaq yesterday.


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