MiddleBrook Pharmaceuticals wins OK from FDA

MiddleBrook Pharmaceuticals Inc. has won federal approval for its flagship drug, a move that not only keeps the Germantown biotech alive, but also sends it on the pathway to getting sold to a larger pharmaceutical.

With the green light to begin selling its first drug developed in-house, a once-a-day treatment for strep throat for patients older than 12, MiddleBrook (formerly Advancis Pharmaceutical) also joins a short list of area companies with marketable drugs.

And it boosts the value of MiddleBrook's otherwise flagging stock price. Shares of the company closed at $1.25 apiece Jan. 23. Hours after announcing the the Food and Drug Administration's approval, MiddleBrook saw its share price more than double to $3.01 a share.

Analysts said they didn't think the company could survive an FDA rejection of its drug.
Instead, the agency's approval of the strep throat drug, called amoxicillin pulsys to be marketed under the brand name Moxatag, sets the company up for a potential sale at a higher price to a buyer interested in a soon-to-be-launched product in a $400 million market and MiddleBrook's once-a-day dosing technology across several antibiotic platforms.

"We now look forward to continuing our ongoing strategic evaluation process from a position of greater strength with this approval in hand," said Ed Rudnic, president of MiddleBrook, which has been exploring whether to sell all or parts of the company for months.

While the company has been selling several doses of Keflex, a drug it bought from Eli Lilly & Co. in 2004, it sold the rights to that drug to investors to raise $7.5 million to pay off a longtime loan and raise much-needed cash to keep operating through the first quarter of this year. FDA approval of amoxicillin pulsys will earn MiddleBrook another $2.5 million under the terms of the Keflex deal.

The company had to ride several twists and turns before reaching this point, the apex for most biotech firms. MiddleBrook failed its first advanced human trials for amoxicillin pulsys in 2005, and then turned those results around a year later.

In that second phase III trial, the company tested the drug on more than 600 patients over a period of 10 days, rather than the previously attempted seven days. In 10 days, MiddleBrook found that its drug performed as well when administered once a day when compared to the standard penicillin, normally taken four times a day.

The company has agreed to conduct another study on amoxicillin pulsys' effectiveness and safety on patients younger than 12 years.

But MiddleBrook's troubles didn't end there. It saw its first FDA approval application get rejected for lacking certain manufacturing information, forcing it to submit a second application that did get accepted last year.

The company even had to scrap its seven-year-old name, Advancis, when it lost a trademark lawsuit in late 2006 against Sanofi-Aventis.

At least two other area biotechs face the same milestone soon, starting with Rockville's Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), which is awaiting an FDA decision on its schizophrenia drug as early as July.

Prestwick Pharmaceuticals Inc. of D.C. recently won unanimous backing from an FDA committee for its drug to treat chorea associated with Huntington's Disease, but is still subject to FDA's final call.

If MiddleBrook is sold, it won't be the first local biotech to change its name this year. This week, Teva Pharmaceutical Industries Ltd. announced it intended to buy Rockville-based CoGenesys Inc., an early-stage spinoff of Human Genome Sciences Inc. (NASDAQ: HGSI), for $400 million.

Source : www.bizjournals.com

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