After several years of reversals and failed trials, MiddleBrook Pharmaceuticals Inc. announced yesterday that it had won federal approval to sell a once-a-day version of the top-selling antibiotic amoxicillin to treat strep throat in patients 12 or older.
"It's a significant step for the company," said Greg Wade, an analyst for Pacific Growth Equities, who projected that the product, called Moxatag, could generate $100 million in annual sales.
MiddleBrook also is working on a tasteless, sprinkle-on version of Moxatag that would work with younger children, potentially opening up wider use with kids who resist taking multiple daily doses of antibiotics for fevers or ear infections.
Robert Bannon, MiddleBrook's vice president of investor relations, said, "Even a sick child will eat pudding or ice cream or something."
Even the age 12-and-up version is a huge boost for a company that had only $7.6 million in sales through the first three quarters of 2007, lost $33.2 million over that period and was running low on cash.
MiddleBrook shares soared $1.74, or 139 percent, to close at $2.99, making it the biggest percentage gainer on the Nasdaq stock market.
The Germantown company had already announced it is seeking a buyer or merger partner, and Wade said the approval was likely to accelerate the process.
"Winning approval [for Moxatag] certainly gets the attention of a larger audience," he commented.
Bannon said MiddleBrook, which has 31 regular employees and 30 contract sales representatives, doesn't have the capacity to market Moxatag on a large scale and needs "a large-pharma-type partner that has a thousand sales reps."
While MiddleBrook could partner though a licensing agreement, Bannon continued, "our plan A would be an outright acquisition of the company with someone with an appropriate sales infrastructure."
He said the company hoped to complete its "strategic process" in time for the acquirer or partner to launch Moxatag for next fall's cough-and-cold season.
When it completes its strategic process, MiddleBrook hopes to have a partner who can finance a pivotal test of timed-released Keflex, a version of another popular antibiotic, cephalexin. It is also planning midstage trials of Moxatag for younger children.
The FDA approval came as the company was running low on money. By the end of the third quarter of 2007, MiddleBrook was down to $5.9 million in reserves - and burning through cash at a rate of $6.3 million a quarter.
