To: SJS who wrote (377 ) 9/25/1998 1:28:00 PM From: s jones Read Replies (1) | Respond to of 645
24 September 1998 Melbourne, Australia -- Biota Holdings Limited announced that their development partner, Glaxo Wellcome plc, has today applied to the European and Canadian regulatory authorities for approval to market the inhaled anti-viral medicine, RelenzaTM (zanamivir) for both the treatment and prevention of influenza. Phase III clinical data show consistent benefit with Relenza in the management of influenza. Data from a phase III treatment trial and from a large phase III preventative study, which form part of the submission, will be presented on Friday 25th September and Saturday 26th September at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego. Influenza patients treated with inhaled zanamivir (10mg twice daily for five days) had less severe symptoms throughout the course of their illness and attained relief from the major symptoms of influenza up to two and half days earlier than those receiving placebo. The results also show a reduction in complications associated with influenza in high-risk patients, including the elderly and those with respiratory and cardiovascular disease. The majority of patients given Relenza for prevention of influenza (10mg once daily for four weeks) were protected from acquiring influenza. Patients taking Relenza experienced no more side effects than those taking placebo. Relenza is the first inhaled drug in a new generation of influenza virus-specific treatments known as neuraminidase inhibitors, which work by interfering with the life cycle of the influenza virus. It blocks an enzyme, neuraminidase, which is present on the surface of the virus, thus preventing the virus from spreading the infection from one cell to another. Relenza has been studied in over 4,000 patients in clinical trials. The medicine is given through an inhaler, which ensures that it is delivered directly to the surface of the respiratory tract -- the only site of influenza virus infection in humans. It also means that high levels of the medicine reach the site of virus replication. Biota's Chief Executive Officer, Dr. Hugh Niall, said "I am most pleased to note this next stage in the progress of this exciting collaboration. Glaxo Wellcome's European and Canadian filings to regulatory authorities to market Relenza for the treatment and prevention of influenza are important milestones for Biota. Relenza is the first major innovation in influenza management for around 20 years and we believe is likely to make a significant contribution to the management of respiratory diseases in the future." The drug was invented in Australia in the 1980s and licensed to Glaxo Wellcome by the Australian company, Biota Holdings Limited in 1989. This licence gave to Glaxo Wellcome the rights to develop Relenza and to market the product worldwide. Glaxo Wellcome is a research-based company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and t