Advancis reports Keflex additions will provide significant revenue in 2007

By Jennifer Lanning Drey

Eugene, Ore., May 16, 2006 - Advancis Pharmaceutical Corp.'s 333 mg and 750 mg capsules of Keflex brand cephalexin, which the company announced on Monday had been approved by the Food and Drug Administration, will contribute significant revenue and cash to the company, especially in 2007, said Robert Low, acting chief financial officer, during the Rodman & Renshaw 3rd Annual Global Healthcare Conference on Tuesday.

The company expects to begin marketing the new strengths in July.

"We now have a significant opportunity to grow the Keflex franchise over the next two years or so and to contribute significant revenue and net cash to the company in 2006 and especially in 2007," said Low, during his presentation at the conference.

The FDA decision was Advancis' first approval for a supplemental New Drug Application.

Cephalexin is the third most prescribed outpatient antibiotic in the United States with more than 25 million prescriptions written annually, Advancis said on Monday when it announced the approval.

Advancis' net Keflex sales in 2005 were $4.8 million.

As of March 31, Advancis reported $22 million of cash, cash equivalents and marketable securities on hand. Low said that amount, along with cash generated from previously commercialized Keflex products, should be enough to see it through the phase 3 clinical testing of amoxicillin Pulsys, a once-daily product candidate being tested for treatment of acute pharyngitis.

Applying Pulsys technology to amoxicillin and Keflex brand cephalexin is the company's primary near-term focus, Low said during the healthcare conference.

"If we're successful with amoxicillin and Keflex, we believe Pulsys can be used to improve a number of other antibiotics in the future that could be added to our product pipeline," said Low during the healthcare conference.

Advancis is nearing completion of enrollment in the clinical trial for amoxicillin Pulsys and if successful, the company plans to file a New Drug Application for the product in 2007.

The company is also running a phase 1 clinical trial testing the Pulsys technology in Keflex cephalexin, and is on schedule to launch a related product in 2009, with others likely to follow, according to Low.

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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