FDA still reviewing supplemental NDA for Advancis' Keflex products

By E. Janene Geiss

Philadelphia, April 21 - Advancis Pharmaceutical Corp. announced Friday that the Food and Drug Administration has informed the company that its review of the supplemental New Drug Application for additional Keflex (cephalexin capsules) products is still ongoing.

"We were notified yesterday that the agency has not yet completed their review of our application," Edward M. Rudnic, president and chief executive officer of Advancis, said in the release. "We draw no negative inference from the notification and we continue to prepare for a launch of the products this July, assuming FDA approval."

Advancis acquired the rights to manufacture, market and sell the Keflex brand of cephalexin in the United States in July of 2004.

Cephalexin is the third most prescribed outpatient antibiotic in the United States, with more than 25 million prescriptions written annually. Advancis' net Keflex sales in 2005 were $4.8 million.

Advancis said it began phase 1 studies for the development of a once-a-day Keflex product using the company's proprietary Pulsys technology in late 2005 and hopes to advance the product candidate into phase 2 clinical development in the first half of 2007.

Advancis' once-daily Keflex Pulsys product candidate is designed to increase the convenience of cephalexin therapy, which is currently dosed two to four times daily for a period of seven to 14 days. There is no once-daily cephalexin product approved for marketing in the United States, officials said.

The company also said Friday that it was on schedule to complete its ongoing pivotal phase 3 trial of Amoxicillin Pulsys for adolescents and adults with pharyngitis/tonsillitis by the end of this cold and flu season.

Advancis said it enrolled a total of 525 patients as of the close of business on Thursday and expects to enroll a total of at least 600 patients in the trial. The company said it plans to announce top-line trial results in the third quarter of 2006.

Advancis is a Germantown, Md., pharmaceutical company focused on the development and commercialization of pulsatile drug products that fulfill substantial unmet medical needs in the treatment of infectious disease.

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