Advancis Drug Passes Its Final Test

Edward M. Rudnic, the chief executive of Advancis Pharmaceutical Corp., waited yesterday for a fax with the results of final-stage testing on his company's first product.

Seven years ago, Rudnic sketched out a technology that would create a once-a-day version of amoxicillin, an antibiotic used to treat strep throat, pharyngitis and tonsillitis. But after the drug failed a round of tests last year, Advancis changed the treatment pattern by testing the drug in patients for 10 days instead of seven.

The results would determine the fate of the product -- and, perhaps, the Germantown company. When the fax machine began printing, Rudnic finally had the news he'd been waiting for.

The drug worked.

"I am pretty sure my heart stopped beating for at least 30 seconds," Rudnic said. "It was good. It felt real good."

The success capped a painful year for Advancis, which laid off about half of its approximately 100 employees, including many senior executives, after the drug failed its first tests. It also cost the company a partnership with a big drug company, Par Pharmaceutical Cos.

Almost immediately, yesterday's news spread. Advancis shares climbed $1.45, to $4.57.

"When you finally make it this far, it's a big relief," Rudnic said.

The results easily could have gone the other way.

The firm's drug, Amoxicillin Pulsys, attacks bacteria in time-released, staccato bursts. That technology also allows patients to take it once a day instead of the typical four times. To qualify for approval, the drug not only had to prove it wasn't inferior to penicillin but also had to be at least 85 percent effective at curing strep throat.

It barely reached the 85 percent threshold this time around, so close that it would have failed if just one of the patients had not been cured.

The drug is still subject to approval by federal regulators, but Rudnic said he did not think it mattered that it had just barely reached its threshold for success.

"All that matters is that it got there," he said.

Y. Katherine Xu, an analyst for Pacific Growth Equities LLC, which has provided investment banking services for Advancis, agreed. "The data is pretty clean," she said. "I think they are in good shape."

Advancis now has a chance to change how one of America's most popular antibiotics is administered. About 59 million prescriptions were written for Amoxicillin Pulsys last year, with sales totaling more than $640 million.

Its attraction for consumers is the need to take the drug only once a day. But investors and doctors have also been considering the potential public health benefits. Because of the staccato delivery, less of the drug needs to be taken overall, which helps battle resistance.

Rudnic said the company would now have to start hiring people to gear up for a product launch, which could come toward the end of next year. The company had about $20.9 million in cash as of June 30.

And now, for the first time in a long time, it has some momentum.

"This is a good day," he said.