Advancis completes enrollment in anti-infective trial

Advancis’ adult and adolescent pivotal program began on October 15, 2004. Over the coming weeks, patients will complete their treatment and follow-up visits, and Advancis and its clinical research organization will collect and analyze the clinical data. The company expects to publicly report top-line results on or around mid-June 2005.

Advancis has also enrolled a total of 421 pediatric patients to date in its Amoxicillin Pulsys phase III trial for the treatment of pediatric patients with acute pharyngitis/tonsillitis. This trial for a “sprinkle” formulation of Amoxicillin Pulsys was initiated on January 5, 2005 and the company expects to announce top-line results in July 2005.

“We completed enrollment in our adult and adolescent phase III trial on schedule, and expect that our rapid enrollment of pediatric patients will continue to meet or exceed our expectations,” said Dr Barry Hafkin, Advancis senior vice president and chief scientific officer. “We look forward to reporting the results of our adult trial in June, our pediatric trial in July, and if successful, filing our NDAs for the products by the end of 2005 and commercially launching by the end of 2006.”

Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis, and sinusitis.

Advancis has partnered with Par Pharmaceutical Companies to develop Amoxicillin Pulsys. The companies have agreed to jointly market the adult and pediatric products and to split operating profits equally.