u.s. working to ready more flu drugs, congres

U.S. working to ready more flu drugs, Congress told

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http://www.reuters.com/article/domes...59K3YD20091021

U.S. working to ready more flu drugs, Congress told
Wed Oct 21, 2009 11:38am EDT

By David Morgan

WASHINGTON (Reuters) - Approval for the emergency intravenous use of experimental new antiviral drugs for patients critically ill with H1N1 swine flu could come within days, U.S. Health and Human Services Secretary Kathleen Sebelius said on Wednesday.

The new drugs, which could supplement 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.

"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 told a hearing of the Senate Homeland Security and Governmental Affairs Committee.

"It is imminent," Sebelius said, and when asked if a decision could come in a matter of days, she replied: "We hope that's the case."

Tamiflu, known generically as oseltamivir and marketed under license from Gilead Sciences Inc by Roche Holding AG, is a pill in a class of antivirals known as meuraminidase inhibitors.

During the 2008-2009 flu season one of the circulating influenza viruses, an H1N1 strain distantly related to the pandemic swine flu, developed resistance to Tamiflu. So far the pandemic swine flu is almost fully susceptible to Tamiflu but doctors say that could change at any time.

A similar drug is Relenza, known generically as zanamivir, made by GlaxoSmithKline Plc under license from Australia's Biota Inc, and is inhaled, although it can be formulated for intravenous use.

PROMISING NEW DRUG

Because influenza viruses mutate so quickly, health officials are keen for new drugs and several are in the works.

Furthest along in the pipeline is Biocryst Pharmaceuticals Inc's and Shionogi & Co's peramivir.

BioCryst has said it was starting two late-stage trials testing the intravenous formulation of peramivir to treat hospitalized patients with serious influenza.

In 2007, BioCryst was awarded a $102.6 million, four-year contract from HHS to develop peramivir for the treatment of influenza. Last month it got another $77.2 million from the department to complete late-stage development.

"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.

The U.S. government is racing to vaccinate as many people as possible against H1N1, as well as against seasonal influenza, but production has been slow. Sebelius said companies are working to speed things up, but officials all agree that better vaccine technology is needed.

The flu vaccine is made using old technology that involves growing the virus in chicken eggs, and it takes months to make a new formulation to match circulating flu strains.

"It is important that when the next pandemic hits, we are better prepared to mount a speedy, agile response," Sebelius said in her written testimony to the panel.

For the current season, the U.S. government has ordered up to 250 million doses of H1N1 vaccine from five companies: AstraZeneca, Sanofi-Pasteur, Novartis AG, GlaxoSmithKline and CSL.

(Reporting by David Morgan and Maggie Fox; Editing by Eric Beech)