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MiddleBrook Wins Approval For Strep Throat Treatment
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"It was especially volatile -- even for this industry," Rudnic said. In 2005, the Pulsys technology, which allows antibiotics to attack bacteria in time-released bursts, failed. Six years and $50 million in research culminated in a final round of human testing, in which the drug had to prove it wasn't inferior to penicillin -- the standard, four-times-a-day dosage that has been used since the 1940s -- and at least 85 percent effective at curing strep throat.
It failed to do so, and caused the company to lay off about half of its 100 or so employees, including many senior executives. It also cost Advancis a partnership with a big drug company, Par Pharmaceutical.
In 2006, Rudnic tried again and tested the drug for 10 days instead of seven. This time, it was so close to the 85 percent threshold, it would have failed if just one of the patients had not been cured.
The Food and Drug Administration denied the firm's initial application last year, and the company considered putting itself up for sale as the financial pressure mounted. It had burned through cash just to get its product through the final stage of development. To combat losses, it reduced its workforce through attrition and put aside developing other products.
Now, MiddleBrook will study Moxatag in children under 12 and submit a completed study within five years.
Yesterday, friends in the industry sent Rudnic congratulatory calls and e-mails.
"About one year ago, nearing another critical milestone, I gave him a big bottle of Scotch and told him we'd get together no matter what," Holaday said. "Now I'm planning on having a sip of Scotch to celebrate his victory."
