ADVANCIS REACHES AGREEMENT FOR RESUBMISSION OF AMOXICILLIN PULSYS NDA

Advancis Pharmaceutical announced positive results from its meeting with the FDA regarding its once-daily Amoxicillin Pulsys product for the treatment of adolescents and adults with pharyngitis/tonsillitis (commonly referred to as strep throat). Advancis reached agreement with the FDA on the additional information required for its new drug application (NDA) filing to be accepted.

Amoxicillin Pulsys is a once-a-day pulsatile-release formulation of amoxicillin for oral administration. It is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and adolescents with tonsillitis and/or pharyngitis.

In August 2006 Advancis announced that the company's Phase III trial in 620 adult and adolescent patients with acute pharyngitis/tonsillitis 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-mg tablet for 10 days, versus the standard comparator therapy of 250 mg of penicillin VK dosed four times daily, for a total of 1 g per day, for 10 days.

Group A streptococcus, the primary bacteria causing pharyngitis, have been uniformly susceptible to amoxicillin and have not developed resistance to the penicillins, despite the long-term use of amoxicillin for pharyngitis.