Japan Approves Relenza, Inhalation Treatment For Flu

MELBOURNE, AUSTRALIA -- -- Biota Holdings Limited announced today that its marketing partner Glaxo Wellcome plc had received approval from the Japanese Ministry for Health and Welfare (MHW) to market Relenza (zanamavir for inhalation) for the treatment of influenza in Japan. This represents an unusually fast new drug approval in Japan as the application was only submitted on August 2 of this year. Relenza is the first neuraminidase inhibitor for the treatment of influenza.

This approval means that Relenza will be available in Japan in time for the winter 1999/2000 influenza season. In the first two months of 1999 alone, more than 1100 predominately elderly people died in Japan as a result of influenza and its complications. Biota's Chief Executive Officer Dr, Hugh Niall said, "This approval is very timely as the peak period for influenza is often between January and March. Relenza will be available to assist in the management of any new influenza strains which might not be covered by current vaccines."

Influenza is one of the most common acute respiratory illnesses and can affect between 10 and 15 percent of the population in a normal year. This number can increase significantly during severe epidemics. Influenza sufferers are currently prescribed a combination of antibiotics, cold and cough preparations and anti-inflammatories in an effort to fight the effects of the illness.

Dr. Niall said, "This Japanese approval means that Relenza would now be available for treatment in all the major markets." Relenza is already approved in 30 countries including the US and all 15 member states of the European Union. The Japanese submission was compiled using the phase III data used to support the other regulatory submissions. Phase IV clinical trial requirements have been agreed with the MHW.

Relenza is administered by oral inhalation. This targeted approach enables the drug to be delivered directly to the site of the infection in the respiratory tract, the primary site of influenza virus in humans. With this approach the first dose begins to function within seconds to immobilise and kill the influenza virus.