Cleveland BioLabs gets back in game

By David Robinson
The Buffalo News
April 6, 2008

Cleveland BioLabs is back in the race to develop an anti-radiation drug for the U.S. military.

The Buffalo biotechnology company looked like it was left at the starting blocks three months ago, when a competitor, Osiris Therapeutics, won a contract that could be worth as much as $225 million from the Defense Department.

But Cleveland BioLabs got back into the game last week when it won a developmental contract worth up to $8.9 million from the Defense Department to develop its Protectan drug as a way of treating soldiers who have been exposed to radiation.

While the contract doesn’t commit the government to buying any Protectan, it gives Cleveland BioLabs valuable funding to continue its research on the drug, which is in the testing stage and still needs to be approved for use in humans.

There is a race in terms of who will develop their product first,” says Michael Fonstein, president and chief executive officer of Cleveland BioLabs, one of the poster children for the region’s life sciences push.

It’s a high-stakes race, too. We could be talking about potential orders for hundreds of thousands of doses — and possibly millions — that would be stockpiled by the U.S. military, Homeland Security, or even foreign governments such as Israel.

That’s why Fonstein thinks it’s so important to be first to develop an approved anti-radiation drug. “That company will probably take the cheese,” he says. “I think we’re in a good position to win.”

With Cleveland BioLabs’ Protectan costing around $200 a dose, 1 million orders would mean roughly $200 million in sales. That would turn Cleveland BioLabs from a fledgling research company to a full-blown drug manufacturer in a hurry.

Even better, from Cleveland BioLabs’ perspective, is that the stockpiled doses eventually lose their effectiveness, which means ongoing sales to keep the supplies fresh. If the military market fully develops, if Homeland Security starts stockpiling doses for civilians, if Israel does the same, Fonstein thinks Cleveland Bio- Labs could be looking at a market worth $500 million a year.

That’s a lot of “ifs,” and it doesn’t even count the biggest ifs of all: If Protectan works and if the drug wins approval for use from regulators.

Fonstein is encouraged by recent test results, which showed that Protectan helped monkeys survive two-thirds of the time after they were exposed to lethal levels of radiation and were given the drug 48 hours after exposure. That was much better than the 25 percent survival rate among a control group.

Those results, released publicly last week, weren’t available when Cleveland BioLabs originally applied for the contract that ended up going to Osiris, whose drug has the disadvantage of costing about $10,000 a dose and can only be administered in clinical settings. Protectan, in contrast, can be administered by fellow soldiers on the battlefield.

But those advantages won’t help Cleveland BioLabs if Protectan can’t show that it works well enough — and is safe enough — to win approval for military use and then later on, from the U.S. Food and Drug Administration for medical use to ease the side effects of radiation therapy in cancer patients and others.

The medical market is bigger, but it also is further away,” Fonstein says.

Cleveland BioLabs hopes to have Protectan ready for military use in less than three years, mainly because the approval standards for military use aren’t as stringent as the ones used for medical use. Full-blown FDA approval will require additional testing beyond that required by the military, Fonstein says.

What matters now, though, is that the race is back on, and Cleveland Bio- Labs is back in it.

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