In midstage trials, Human Genome Sciences reported that the 900-mcg dose matched Pegasys in safety and effectiveness, but because it is given less often, patients missed work less often.
But an independent data monitoring committee reported "serious pulmonary adverse events" in the 1,200-mcg group. It recommended cutting the doses for those patients to 900 mcg, and Human Genome Sciences and its partner, Novartis Pharmaceuticals, agreed.
HGS said it couldn't provide details about the "serious adverse events" because it did not have all the data available to the committee and because it didn't want to bias a current study.
Watkins said the company was still on track to apply for approvals for the drug in the fall of 2009.
Human Genome Sciences has no drugs currently on the market and lost $169.6 million through the first three quarters of 2007. It has three drugs in final-stage testing, including Albuferon.
Another is an anthrax treatment being developed under a $165.2 million contract with the Department of Health and Human Services. Human Genome Sciences hopes to begin sales to the government by the end of this year.
It is also in final-stage testing of LymphoStat-B, a drug for lupus. While it hasn't specified a market size, it has characterized both LymphoStat-B and Albuferon as "potential blockbusters."
With Albuferon, Human Genome Sciences can collect up to $507 million in milestone payments from Novartis if development is successful. It has already received $130 million of that. If the drug gets to market, Novartis and Human Genome Sciences will split the U.S. profits 50-50, and HGS will collect royalty payments on sales elsewhere.
bill.salganik@baltsun.com
