BIRMINGHAM, Ala. (
) -- As
seeks to raise money from investors later this week, the U.S. government is seeing light demand so far for the company's antiviral flu drug peramivir.
With evidence emerging that H1N1 flu activity in the U.S. is peaking already, significant additional peramivir orders may not be needed.
A total of 829 treatment courses of peramivir have been shipped from the government's National Strategic Stockpile since the drug was made widely available on Oct. 23, according to Anita Patel, a health scientist working at the Centers for Disease Control and Prevention, the government agency in charge of distributing peramivir to doctors who request it as an emergency treatment for seriously ill H1N1 flu patients.
Patel disclosed the volume of peramivir shipments on a Nov. 13 conference call of the National Biodefense Science Board (NBSB), an advisory group under the auspices of the U.S. Department of Health and Human Services.
The 829 courses of peramivir were used to treat 533 patients, said Patel. Each course of peramivir includes enough drug to dose for five days, so some patients were treated with two courses, or 10 days, of peramivir.
"There's a total of 93% of our
peramivir supply that remains, so we're confident that the current supply that we have will meet the demands as they've been set forth in the last couple of weeks," said Patel.
BioCryst sold 10,000 courses of peramivir to the U.S. government for $22.5 million on Nov. 5. Another 1,200 doses of the drug were donated. The drug, given intravenously, is still considered experimental and is not approved anywhere in the world.
Under the rules set forth by the U.S. Food and Drug Administration, doctors are only allowed to use peramivir to treat patients who are hospitalized with H1N1 flu and are not responding to currently approved antiviral drugs, including
BioCryst has another 30,000 courses of peramivir that could be purchased by the U.S. government under its existing order, but the comments made by the CDC's Patel combined with a tick down in recent flu activity suggests the extra peramivir may not be needed.
The CDC has reported a decrease in flu activity over the last two weeks, coinciding with an increase in the number of people who are receiving vaccinations with the new H1N1 flu vaccines.
On the NBSB conference call last week, public health officials expressed relief that in many parts of the country, H1N1 flu activity appears to be on the wane.
"It is possible that we're near the top of the peak of this current wave of the pandemic," said CDC's Jay Butler. He did caution, however, that another wave of H1N1 activity is possible as the country moves into the colder winter months. This could cause a resurgent spike in H1N1 infections.
H1N1 flu is the most serious viral outbreak to hit the globe in decades, but the relative number of patients hospitalized and/or dying from the flu strain in the U.S. remains low.
Last week, the CDC reported that 22 million Americans had been infected with H1N1 flu to date, resulting in 98,000 hospitalizations and approximately 4,000 deaths. The numbers made for scary headlines in major newspapers, but it also means that less than less than one-half of one percent of H1N1-infected patients are sick enough to be hospitalized.
The death rate, to date, from H1N1, is less than two-hundredths of one percent in the U.S.
Approximately 36,000 people die each year during a typical flu season, according to government statistics.
Meantime, BioCryst plans to price Thursday night a follow-on offering of five million shares of the company's stock, with another 750,000 shares available if demand is strong.
BioCryst management wants to raise money now because the company is uncertain about the ultimate size of government orders for peramivir and sees its current stock price as an opportunity to strengthen the company's overall financial health so that it can develop drugs other than peramivir, said one healthcare investor who spoke with BioCryst management in advance of the offering.
"BioCryst is hopeful that the U.S. government orders more peramivir and that it can sell peramivir to foreign countries, but right now, the company doesn't really know if it's going to sell a lot or none at all," he added.
-- Reported by Adam Feuerstein in Boston
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