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In an Australian first, the Monash-developed influenza drug Relenza has been given the green light for commercialisation.

By Julie Ryan

After more than 20 years in the making, a drug which has been fully developed in Australia has been approved for human use by the Australian Drug Evaluation Committee - a milestone for Australia's scientific community.

The influenza drug Relenza, designed and synthesised by Professor Mark von Itzstein and his team at Monash University's Victorian College of Pharmacy, puts Australia on the international map as a viable, competitive research and development nation.

The drug's path to approval has involved years of collaboration between a number of parties including Monash, CSIRO, the Australian National University and pharmaceutical companies Glaxo Wellcome and Biota.

Professor von Itzstein says that despite the recent setback when the drug failed to gain Food and Drug Administration (FDA) approval for use in the US, he is confident that it will eventually be approved.

"The fact that it hasn't been approved by the FDA should not detract from its scientific value and its proven success in clinical trials," he said.

This orally inhaled drug is the first in a new generation of specific treatments for the flu, and works by inhibiting the life cycle of the virus by blocking the enzyme that allows it to multiply.

This inhibiting action traps the virus in already infected cells, preventing it from spreading to neighbouring cells and allowing the body's immune system to fight the virus more quickly and effectively.

Administering Relenza via an oral inhaler ensures that the drug is delivered directly to the surface of the respiratory tract - the only site of influenza infection in humans.

By administering the drug directly to the site of infection and replication, potential side effects are avoided because there is no general distribution throughout the body.

Professor von Itzstein says there are obvious benefits to be gained from royalties from the drug's sale, including important funding for further advanced scientific research in Australia.

"The drug has also been approved for use by the Medical Products Agency in Sweden, which provides the lead for other European countries, and it will soon go for approval in Japan," he says. "And the Asian market has huge potential as many of the new flu strains develop in the region."

Relenza will be available for this year's flu season as a prescription drug from general practitioners.

Researcher Professor Mark von Itzstein says the Asian market has huge potential for the new flu drug.

A new Bachelor of Formulation Science will be offered by the Victorian College of Pharmacy in 2000. The College also offers postgraduate study opportunities. For further information, contact Mr Michael Watson on (03) 9903 9505.