Business

Durham firm developing treatment for H1N1

Posted October 19, 2009 6:19 p.m. EDT
Updated October 19, 2009 7:25 p.m. EDT

— A Durham company is developing an intravenous drug for patients with the flu who are critically ill.

BioCryst Pharmaceuticals Chief Executive Jon Stonehouse said Monday that the experimental drug, Peramivir, could be a tool to battle the H1N1 pandemic. A recent study by the President's Council of Advisers on Science and Technology estimated that the virus could send nearly 300,000 patients into intensive care this season.

"It's the most potent inhibitor of the H1N1 virus," Stonehouse said. "What's encouraging about Peramivir is we've got a drug in an IV form that gets in quickly and hits the virus hard when you need a drug to work quickly."

Other anti-viral medications being used to treat flu patients are either aerosols that are inhaled or pills or liquids that are ingested. Because the flu attacks the lungs and sometimes inhibits digestion, those medications aren't as effective as an IV, Stonehouse said.

BioCryst received fast-track approval in 2006 from the U.S. Food and Drug Administration to develop the drug and is working with an agency in the U.S. Department of Health and Human Services under a $180 million grant to complete clinical trials.

There's no projection on when the drug could receive final approval. Still, the FDA has allowed a handful of physicians nationwide to obtain the drug under a "compassionate use" basis for flu patients after other treatments have failed.

At least seven critically ill patients, including  John Boudrot, have recovered after taking Peramivir, officials said.

Boudrot was in relatively good health until he contracted H1N1 this year and went into DeKalb Medical Center outside Atlanta. The disease started consuming him from inside, and Dr. Robin Dretler, an infectious disease specialist at the hospital, said he was rapidly headed toward death.

"I wanted to get a hold of Peramivir," Dretler said. "I knew who to call – how to get a hold of the drug – and they helped me get the paperwork."

Obtaining a "compassionate use" exemption involves completing an application that officials estimate takes about 10 hours of work. So many physicians are pushing the FDA to upgrade Peramivir to "emergency authorization use," which would allow the government to stockpile it near large cities and allow physicians to use it under strict conditions without filling out extensive paperwork.

Boudrot said he feels lucky to have gotten the drug in time.

"Luck is one way to say it. You know, the grace of God," he said.