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29 October 1998 |
Ref 98/257 |
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Australia's world-first influenza drug, Relenza™, is now poised to enter the United States (US) with the filing of a New Drug Application with the US Food and Drug Administration (FDA).
"The filing of Relenza™ with the US FDA is a major achievement for Australian medical science," says Dr Albert Mau, acting Chief of CSIRO Molecular Science. "It is another indication that Australian scientists can match it with the best in the world."
The drug is the first effective treatment for all strains of 'flu. It is orally administered to directly target the site of infection, the respiratory tract. The international market is estimated to be worth at least $2 billion a year.
Relenza™ is based on fundamental research conducted in CSIRO since the 1980s. Its development was funded by the Australian pharmaceutical firm, Biota Holdings. Global pharmaceutical giant Glaxo Wellcome is commercialising the drug and has conducted clinical trials around the world.
Following the success of these trials, Glaxo Wellcome filed
for regulatory approval in Australia earlier this year and in
Europe and Canada last month.
The 'flu virus has long been a problem because it mutates rapidly,
disguising itself from our natural immune system and quickly
renders existing vaccines ineffective.
On the surface of the virus, CSIRO's Dr Peter Colman and Jose Varghese identified and characterised a small unchanging region that occurs in all strains of influenza - a chink in its armour. Using this data, Biota scientists at the Victorian College of Pharmacy designed a special drug that 'locks' onto this section of the virus and prevents it from replicating.
The clinical trials have shown that the drug significantly reduces the duration and severity of 'flu symptoms, especially if it is taken soon after a person is infected.
"We were delighted at the latest developments which mean that the drug may be available in our pharmacies from next winter," says Dr Mau.
Dr Mau also complimented former CSIRO scientist and now head of Melbourne's Biomolecular Research Institute, Dr Peter Colman, who led the research team.
"Peter's revolutionary approach to drug development is continuing in a number of exciting projects in CSIRO, the BRI and Biota. We've got a number of diseases, such as diabetes, hepatitis and cancer, in our sights," he said.
More information:
Doug Gale or Warwick Glynn, CSIRO 03 9662 7332 or
0417 543 633
(Australia's largest scientific research organisation)
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