Advancis Pharmaceutical will likely double its existing sales force to launch its once-daily amoxicillin employing itsPulsys technology, pending FDA approval, the company said.

The Germantown, Md.-based firm expects to file an NDA for treatment of adults and adolescents with pharyngitis/tonsillitis due to Group A streptococcal infections in late 2006 or early 2007 following positive Phase III clinical trial results, reported Aug. 10.

Advancis is confident it will be able to launch the product successfully without a marketing partner, according to CEO Edward Rudnic. Instead, Advancis said it will ramp up its 75-rep contract sales force, which currently markets the antibiotic Keflex (cephalexin), including a 750 mg capsule that launched in late July. The company purchased Keflex from Lilly in 2004 (¹ Also see "Lilly Sells Keflex Antibiotic To Advancis; Plans For Once-Daily Dosing Underway" - Pink Sheet, 1 July, 2004.).

"Right now, I have to tell you we are incredibly excited and very encouraged by the way that our Keflex 750 is entering the market," Rudnic said during a call announcing the Pulsys Phase III results.

"If Keflex proves to be the product we think it is, and you'll only have to wait weeks to see this thing start to catch on, then I think you're going to see that we don't need a partner for amoxicillin," he asserted.

The company had planned to develop and market amoxicillan Pulsys with Par Pharmaceutical under an agreement signed in 2004. That deal fell through last year after two Phase III studies failed to meet clinical and microbiological endpoints (² Also see "Par Pulls Out Of Advancis Partnership" - Pink Sheet, 3 August, 2005.).

Advancis noted Keflex generics will likely enter the market in two years, at which time the sales force will shift its focus toward amoxicillin Pulsys. However, there may be a period of overlap before the generics are introduced when amoxicillin Pulsys can also be marketed to physicians alongside Keflex, the firm said.

If approved, amoxicillin Pulsys would be the first once-daily amoxicillin product in the U.S., according to Advancis. The company anticipates launching the product, which would address a $300 mil. pharyngitis market, in late 2007 or early 2008. The firm has a pre-NDA meeting with FDA slated for September, Rudnic noted.

The application will be supported with results from Advancis' 620-patient, double-blind, double-dummy, randomized, parallel-group, 50-center non-inferiority Phase III trial that initiated in November 2005.

The study evaluated a 775 mg once-daily dose of amoxicillin Pulsys versus 250 mg of penicillin dosed four times a day for treatment of pharyngitis/tonsillitis due to S. pyogenes (Group A streptococcus) for 10 days.

Primary endpoints of the study were bacteriological eradication at the test-of-cure visit following antibiotic therapy, as measured by throat cultures before and after treatment in per-protocol and intent-to-treat patients.

Bacteriological eradication was 85% in per-protocol patients treated with amoxicillin Pulsys versus 83.4% in those treated with penicillin. For intent-to-treat patients eradication was 82.4% for amoxicillin Pulsys and 78.4% for penicillin.

-Brooke McManus

Advancis Will Go It Alone On Amoxicillin Pulsys

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