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.

"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."