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MiddleBrook Wins Approval For Strep Throat Treatment

By Kendra Marr
Washington Post Staff Writer
Friday, January 25, 2008

MiddleBrook Pharmaceuticals said yesterday that federal regulators have approved its once-daily amoxicillin treatment for strep throat, capping eight years of ups and downs that nearly sank the company.

The approval of Moxatag for adolescents and adults, which could shift how one of the more commonly prescribed antibiotics is used, is a win not only for the Germantown company but also for the Maryland biotechnology industry, which has had few products reach the market in recent years despite spending heavily on research.

At the center of MiddleBrook's drama was its chief executive, Edward Rudnic, the region's chief biotech cheerleader and entrepreneur. He sketched out the idea for the drug on a friend's dining room table. Yesterday, he was finally able to take a deep breath.

"It's always a relief when you have the confirmation in your hands," he said.

Stock in the company, formerly called Advancis Pharmaceuticals, rose 139.2 percent, closing at $2.99, up $1.74. It was the biggest increase since the company went public in October 2003.

Amoxicillin is typically taken three or four times a day. But the Moxatag tablet packs three time-released bursts of medicine into one pill, which is particularly helpful for parents treating a child.

Moxatag is the first product to use MiddleBrook's time-release technology, called Pulsys. It will also be the first drug of its kind on the U.S. market. It is expected to be available in October or November.

Rudnic said MiddleBrook has a lot of options for its next move. He is open to an acquisition or partnership with another company, primarily one that has a large sales force targeting primary-care physicians.

Rudnic, who is chairman of the Tech Council of Maryland, is a pillar of Maryland's biotech community, so a victory for MiddleBrook is also a victory for the young industry. For years, local biotech has been focused on research and development. Only a few local companies are profitable.

Moxatag is proof that the community is maturing, said John Holaday, chief executive of QRxPharma, which is based in Australia but run locally.

"We're anxious to say, 'We can do better than that,' " said Holaday, who has been in the industry 20 years.

MiddleBrook's story is emblematic of the high-risk, high-stakes game of drug development.

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