Advancis Pharmaceutical on track to file NDA for amoxicillin PULSYS.



Advancis Pharmaceutical Corporation recently announced that it had received correspondence from the FDA confirming that the company's recent successful Phase III clinical trial, along with other data, would be considered adequate for filing a New Drug Application (NDA) via the 505(b)(2) regulatory pathway.

Advancis received feedback from the FDA's Division of Anti-Infectives Drug Products, confirming that the regulatory strategy and proposed format for Advancis' NDA filing for its once-daily Amoxicillin PULSYS product for pharyngitis/tonsillitis (commonly referred to as strep throat) was acceptable. The FDA indicated that Advancis' recently concluded Phase III clinical trial in adults and adolescents, along with the company's Phase I pharmacokinetic studies, results from the Company's prior adult and adolescent Amoxicillin PULSYS Phase III trial, and existing academic literature would be sufficient to support an NDA filing. The company anticipates filing the Amoxicillin PULSYS NDA in December 2006 or January 2007.

"We are very pleased to have received agreement from the FDA on our regulatory strategy for Amoxicillin PULSYS and are very eager to file our NDA as soon as possible," said Dr. Edward Rudnic, Advancis president and CEO. "Based on the feedback we received from the FDA yesterday, we have reached agreement that data in-hand and the results of our just concluded Phase III trial will be sufficient to support an NDA filing for Amoxicillin PULSYS for adults and adolescents with strep throat around year-end."

On August 10, 2006, Advancis announced that the company's Phase III trial for the treatment of acute pharyngitis/tonsillitis in adults and adolescents due to Group A streptococcal infections successfully met its primary and secondary endpoints. The Company's Amoxicillin PULSYS dosage form for the treatment of pharyngitis was delivered in a once daily 775 milligram tablet for 10 days, versus the standard comparator therapy of 250 milligrams of penicillin VK dosed four times daily, for a total of one gram per day, for 10 days.

Approximately 60 million prescriptions for amoxicillin were written in 2005 and the antibiotic is indicated for a broad range of infections. Amoxicillin is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). If Advancis' Phase III trial is approved for marketing, physicians prescribing Amoxicillin PULSYS would have available the first once-daily product in the aminopenicillin class for the treatment of pharyngitis while utilizing approximately one-half the amount of amoxicillin currently used.

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