The government really wants drugs (from a Buffalo company)

Sep 21, 2010

Last month I reported a story about the development of an anti-radiation drug from Cleveland Biolabs (based in Buffalo). The medicine is being eyed as a way to treat victims of a nuclear attack. There are no existing medicines that actually clear radiation out of your blood stream if you’ve been exposed – only ways to reduce exposure.

Interested in its potential use in military and homeland security settings, the Department of Defense sent millions of dollars in grants to the company earlier this decade with the hope that they could capture protection against radiation poisoning in a pill. The resulting formula is known as CBLB502.    

Apparently, the military likes what it has seen of 502’s development lately. Cleveland Biolabs was just awarded another $45 million government contract.

The money will be split two ways. A third of it, or $15 million, will be used to finish developing the medicine and its application process with the Food and Drug Administration. 502 is currently in the later stages of clinical trials. According to the limited amount Cleveland Biolabs  has said about the trials (scroll halfway down the page), side effects have been “largely mild or moderate.” Flu-like symptoms were the most common side-effect. And those, on average, went away within two to four hours, according to Cleveland Biolabs.

 According to media reports, the rest of the contract ($30 million) could be used for tens of thousands of doses (37,500 to be exact) of the drug. The military apparently wants to start stockpiling the medicine as soon as (they’re assuming) it’s approved by the Food and Drug Administration. Cleveland Biolabs officials have said studies by the Pentagon show a few million doses could be needed. If this happens, the company would be responsible for providing that medicine. They would then need to acquire Scrooge McDuck-like money storage room.

For my money, you don’t get $45 million from the government if there’s not a better-than-average chance of getting approved by the FDA.  While no medicine is a slam dunk in the FDA’s approval process, news like this gives the impression the medicine has a bright future, even though it has not yet leaped the biggest hurdles in its way (the years-long FDA application process).

The company has been developing the medicine for close to eight years already. This announcement signals the beginning of a transition away from testing and toward production. The company says FDA approval could come in as little as two years. Earlier this summer, 502 was awarded “fast track” status to speed up the review process.