ADVANCIS ANNOUNCES RESULTS FROM ADULT/ADOLESCENT AMOXICILLIN PULSYS TRIAL

Advancis Pharmaceutical and Par Pharmaceutical have announced that the companies' Amoxicillin PULSYS Phase III clinical trial for the treatment of adults and adolescents with pharyngitis/tonsillitis due to Group A streptococcal infections (commonly referred to as strep throat) failed to achieve its desired microbiological and clinical endpoints.

The trial compared Advancis' Amoxicillin PULSYS 775-mg tablet dosed once-daily for seven days to 250 mg of penicillin VK dosed four times daily for 10 days. According to top-line trial data received today, Amoxicillin PULSYS failed to demonstrate statistical noninferiority to the comparator therapy in the primary endpoint - bacterial eradication at the post-therapy test-of-cure visit for patients who successfully completed the trial protocol.

Success in bacterial eradication at the post-therapy test-of-cure visit in the per-protocol population was 76.6 percent of patients with Amoxicillin PULSYS and 88.5 percent with penicillin. These results failed to demonstrate statistical noninferiority. Amoxicillin PULSYS also failed to demonstrate noninferiority in the trial's secondary endpoints, including clinical cure at the test-of-cure visit and bacterial eradication at the late post-therapy visit. Advancis will review the full data over the coming weeks and evaluate what steps, if any, could be taken to improve future outcomes.