Advancis refiles FDA application for antibiotic

December 15, 2006|By Tricia Bishop | Tricia Bishop,sun reporter

Advancis Pharmaceutical Corp., a Germantown drugmaker, filed a new drug application yesterday for Amoxicillin Pulsys, an antibiotic that has had a tough couple of years.

About 18 months ago, the drug had failed in clinical trials, sending Advancis shares plummeting to new lows and leading to company layoffs.

But a retooled trial returned positive results and, yesterday morning, representatives dropped off a compact disc at the U.S. Food and Drug Administration containing the application for approval of Amoxicillin Pulsys -- a moment Chief Executive Officer Edward M. Rudnic called a "significant milestone."

The company plans to announce the move today.

Though Advancis bought the rights to market and sell another antibiotic, the amoxicillin product is the first to near commercialization based on the company's Pulsys technology, which delivers medication in bursts throughout the day, eliminating the need for multiple doses.

Advancis is seeking approval for the drug as a strep throat treatment for adolescents and adults. Currently, the standard treatment is amoxicillin taken three times a day for 10 days. Amoxicillin Pulsys would be taken once a day.

Dr. Daniel Levy, an Owings Mills pediatrician and president of the Maryland chapter of the American Academy of Pediatrics, said the easier a drug is to take the better, particularly when teenagers are in charge of their own medication.

"The easier you make it for the patient, the more likely it is that they'll comply," Levy said.

Barring problems, approval of the drug could come as early as October.

Shares of Advancis closed down 4 cents, or 1.11 percent, to $3.56 in trading yesterday on the Nasdaq stock market.

tricia.bishop@baltsun.com

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