Flu vaccine delay could boost Durham company's treatment

Kathleen Sebelius, secretary of U.S. Health and Human Services, said Wednesday that approval could come within days for emergency intravenous use of experimental new antiviral drugs, including Peramivir, which is being developed by BioCryst Pharmaceuticals.

Sebelius admitted Wednesday that production of vaccine for the H1N1 virus is behind schedule, and people should take precautionary steps to prevent its spread.

Dr. Anne Schuchat of the Centers for Disease Control and Prevention said "more vaccine is coming out every day," but production isn't where it was expected to be at this juncture.

She said officials expect "widespread availability" by mid-November.

Approval of new drugs would complement existing supplies of the flu drugs Tamiflu and Relenza, could help patients too sick to take pills or use an inhaler, and would add to choices available if and when the virus develops resistance to the current drugs, Reuters news service reported.

"The good news is we have encouraging results from several different candidates, and we anticipate final decisions being made by the scientists very shortly," Sebelius said in a speech to the Senate Homeland Security and Governmental Affairs Committee.

She called a decision on the drugs “imminent.”

Of drugs in that class, BioCryst’s entry is the furthest along in development.

Chief Executive Jon Stonehouse called his product “the most potent inhibitor of the H1N1 virus."

"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," he 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.

It is already in limited use by a handful of physicians nationwide in cases where other treatments for flu have failed. At least seven critically ill patients have recovered after taking Peramivir, officials said.

"We are very encouraged by the results, but the scientists will lead our recommendations in terms of getting that antiviral on the market," Sebelius said.