Advancis' new antibiotic formulation hits endpoints

A year after undergoing a painful restructuring, Advancis Pharmaceutical announced that its once-daily formulation of the antibiotic amoxicillin--its lead product--met its primary endpoints in a Phase III trial. The news led to a sharp jump in the company's stock price, which was pummeled a year ago after executives announced that its trial on the new formulation had failed to achieve its endpoints. After laying off half of its staff, Advancis went back to the drawing board and mounted a new trial, changing the treatment period from seven days to 10. The data indicates that the once-daily formulation is not inferior to penicillin and is 85 percent effective in treating strep throat. Advancis now will tackle of market that saw 59 million prescriptions for Amoxicillin Pulsys last year, earning $640 million. Advancis now plans to begin hiring up staffers to handle the launch.

"If approved for marketing, we believe our once-daily version of amoxicillin would represent a major advance in the most widely used antibiotic in the U.S. and would be the first and only once-daily amoxicillin therapy approved for marketing in the United States," said Edward Rudnic, president and CEO of Advancis.

- here's the report on Advancis from The Washington Post