But with Moxatag trials nearing a conclusion, it raised up to $10 million by selling the rights for Keflex, its one drug on the market, to Deerfield Management, an investment fund that is one of its largest shareholders.
MiddleBrook said then the cash infusion would allow it to carry its sale/merger search beyond the January date for the Food and Drug Administration to rule on Moxatag.
For a company that has had a series of sharp ups and downs - not unusual for a small biotech with only a few products in the pipeline - the FDA approval was a huge up.
Bannon said the company's board was in a conference call that began at 5 p.m. Wednesday, the day the FDA's decision was due. But the news didn't come until 5:30, when an FDA e-mail landed, affirming the approval.
The biotech was founded in 2000 as Advancis Pharmaceuticals. It changed its name in June after being sued by Paris drug giant sanofi-aventis, which said the Advancis was too similar to aventis. Its founder and chief executive officer is Edward M. Rudnic, who also chairs the trade group MdBio.
From the beginning, the company worked to develop timed-release versions of approved antibiotics. By working on new delivery systems for already-accepted drugs, rather than on entirely new compounds, MiddleBrook hoped to shorten the time from lab to market.
MiddleBrook said its research showed that releasing pulses of drugs, rather than a steady stream, killed bacteria better. And it promised medications that could be taken once, rather than three times, a day, making it easier for patients to get proper doses.
But the path wasn't smooth. It lost a broad licensing agreement with GlaxoSmithKline in 2004, cutting off potential payments of up to $102 million. And in 2005, clinical trials for a seven-day dosage of Moxatag showed that the drug was less effective than standard treatments.
The company launched another clinical trial for Moxatag, this time with 10 days of dosage. In 620 patients, half took once-a-day Moxatag, and showed a slightly higher rate for killing the strep germs (85 percent vs. 83.4 percent) than the patients who got four-times-a-day penicillin.
bill.salganik@baltsun.com
