HGS's hep C drug Zalbin hits an FDA hurdle

Human Genome Sciences' hopes of gaining quick FDA approval of its hepatitis C drug Zalbin appear to be foundering. The Rockville, MD-based developer released a statement this morning that the FDA had raised concerns about the risk/benefit of albinterferon alfa-2b dosed every two weeks, leading it to conclude that an approval is "unlikely."

HGS's partner on the drug, Novartis, yanked the European application for the drug--dosed at 900 micrograms--back in April, saying it needed to produce a fresh batch of data. Now the two collaborators are considering more work on a new application built around a dose of Zalbin provided every four weeks. As of the end of the first quarter Novartis had paid HGS a little more than $200 million in milestones, with another $300 million still on the line.

HGS's highest hopes lay in Benlysta, which is up for approval as the first new lupus drug in half a century. The developer is pushing for a priority review of Benlysta, which would shave four months off the time it takes to gain the FDA's decision. Analysts say the drug is capable of earning billions of dollars a year.

"In any environment, I think this drug could be one of the large drugs, one of the more successful drugs because it's a biologic, which are usually priced at a premium, and it's the only game in town, for a while anyway, for lupus," Leerink Swann's Joseph Schwartz told the Washington Post.

- check out the HGS release
- here's the story from Dow Jones
- read the report from the Washington Post on Benlysta