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Biota will receive $150million on the handover of it's new drug Zanamivir.It will get further royalty payments of 6 % throughout the patent life of the product.This new and novel compound represents a major step forward in the treatment of influenza.Biota is set to become a major Biotech company with the imminent release of Zanamivir. Biota Annnounces Zanamivir Will Enter Phase III Clinical Trials in May 1997 24 February 1997 Melbourne, Australia, - Biota Holdings Limited (Australian Stock Exchange: BTA) today announced that Glaxo Wellcome plc, the Company's development partner, has informed management that Phase III clinical trials of Zanamivir, or GG167, for the treatment of influenza, planned to start in 1997, will begin in Australia in May. This Southern Hemisphere trial will be a part of a comprehensive world-wide Phase III programme which will also include two separate pivotal proof of efficacy studies to be initiated in the Northern Hemisphere from October of this year. Results from the Phase IIB studies from the Northern Hemisphere, together with those from earlier studies confirm that zanamivir is a potentially valuable therapy for influenza. These data allow optimisation of the design of the Phase III programme. Zanamivir will be administered twice daily for 5 days in these trials using Glaxo Wellcome's proven DiskhalerT technology for inhaled dosing directly into the lungs. Human studies conducted during the last few months have confirmed that the DiskhalerT delivers zanamivir consistently and effectively throughout the respiratory tract. Lung delivery ensures that the drug is given directly to the site of the flu infection. The DiskhalerT, based on the well established device used by millions of asthma patients, has been well accepted by patients in all clinical trials of zanamivir conducted to date. Concurrent with the Phase III programme, Biota in collaboration with Biostar, will continue to develop and commercialise a rapid and easy-to-use diagnostic aid for influenza. World-wide filing for zanamivir is planned to take place in the second half of 1998. "The advancement of zanamivir into pivotal trials is an important milestone for the Company. With a product in Phase III and a pipeline of diagnostics and therapeutics, Biota is well positioned for growth within the biotech marketplace," said Dr. Hugh Niall, Chief Executive Officer of Biota. "We are particularly pleased that the final phase of clinical trials on zanamivir, a discovery of Australian science, will begin in Australia. This speaks of the high quality of Australian clinical research and the success of earlier clinical trials carried out by Glaxo Wellcome Australia." Biota and Glaxo Wellcome estimate that there are more than 350 million cases of influenza around the world each year. In the USA, influenza and its complications represent the sixth leading cause of death. Glaxo Wellcome is undertaking the development of zanamivir as part of a collaborative agreement with Biota Holdings which also includes commercialisation of the drug. Biota Holdings Limited is listed on the Australian Stock Exchange. The Company based in Melbourne, is engaged in the funding and management of an R&D program focusing principally on the discovery of new human pharmaceuticals for the treatment of viral respiratory diseases and cancer. The Company's ADRs trade in the US on the pink sheets at a ratio of three shares to each ADR. Diskhaler is a Trade Mark of the Glaxo Wellcome group of companies For further information please contact: Mr. Richard A Wadley | ||||||||||||
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