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Biotech / Medical : Biota -- Ignore unavailable to you. Want to Upgrade?

To: Epicenter who wrote (30)	2/10/1999 5:07:00 AM
From: Henrik	Respond to of 46

Australian News : BIOTA HOLDINGS LIMITED 1999-02-09 ASX =================================================================== 10 Feb. 99 - BTA closed @ A$8.71 up .46 = 5.6% vol. 815,432 on ASX Wednesday =================================================================== HOMEX - Melbourne +++++++++++++++++++++++++ Melbourne, Australia - 9 February 1999 - Biota Holdings Limited announced today that the Australian Drug Evaluation Committee (ADEC) has recommended approval of Relenza(R) (zanamivir for inhalation), for the treatment of influenza. "We are delighted that Australia is the first country where Relenza has received recommendation for approval," said Dr. Hugh Niall, Chief Executive Officer of Biota Holdings Limited. "This is an exciting day for Biota and the Australian biotechnology community," continued Dr. Niall. "Australia has a long history in influenza research and it is most appropriate that this breakthrough drug is recommended for approval here first." "The development of Relenza has involved a number of people and institutions - notably Glaxo Wellcome, Dr. Peter Colman's team at the CSIRO, Dr. Mark von Itzstein's team at the VCP (Monash University) and Dr. Graeme Laver's team at the ANU, and is another example of Biota adding value through research." Glaxo Wellcome Australia is Biota's Australian marketing partner for Relenza. Under the agreement with Glaxo Wellcome, Biota will receive a royalty rate of 10% of net sales in Australia. Glaxo Wellcome Australia's Managing Director, Mr Colin Armit, said "We are very proud of this achievement and feel it is appropriate that Australia has become the first country in the world to obtain a recommendation for marketing approval of this 'home grown' product." Regulatory market clearance application filings are also currently under review with U.S., European, and Canadian regulatory bodies. Relenza is an orally inhaled drug for treating influenza and the first in a new generation of specific treatments for the influenza virus known as neuraminidase inhibitors, which work by interfering with the life cycle of the influenza virus. Relenza blocks the neuraminidase enzyme on the surface of the virus, preventing spread to neighbouring cells within the respiratory tract. Administering Relenza via an oral inhaler ensures that the drug is rapidly delivered directly to the surface of the respiratory tract - the only site of influenza virus infection in humans. This means that high levels of the drug reach the site of virus replication, while minimising potential side effects by avoiding general distribution throughout the body. Relenza has been studied in over 4,000 patients to date in clinical trials. Biota is an Australian listed company (BTA) based in Melbourne and engaged in the funding and management of a research and development 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. For further information please contact: Dr. Hugh Niall Chief Executive Officer Biota Holdings Limited Telephone: 61 3 9529 2311 Elizabeth Field/Michael Moore Turnbull Porter Novelli Telephone: 61 3 9289 9555

To: Epicenter who wrote (30)	2/10/1999 5:18:00 AM
From: Henrik	Read Replies (1) \| Respond to of 46

Swedish News : BIOTA HOLDINGS LIMITED 1999-02-10 ASX ===================================================================== Yesterday Australia, Sweden today - tomorrow: The World (TV News headline in Australia today Feb. 10) ===================================================================== HOMEX - Melbourne +++++++++++++++++++++++++ Dicta Holdings Limited advises that Glaxo Wellcome has received approval from the Medical Products Agency in Sweden to market Relenza(zanamivir) for the treatment of influenza A and B. In addition,Biota was notified yesterday by the Australian Drug Evaluation Committee (ADEC) of its recommendation for approval to market Relenza for the treatment of influenza A and B. These are the first major steps in the world-wide marketing of Relenza. Sweden will now act as the Reference Member State in the Mutual Recognition Process for the purpose of obtaining approval in the other countries of the European Union. Approvals in European countries are consequently expected to follow later this year. 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 to the healthcare providers that serve them. Biota is an Australian listed company (BTA) based in Melbourne and engaged in the funding and management of a research and development 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. For further information please contact: Dr. Hugh Niall Elizabeth Field/Michael Moore Chief Executive Officer Turnbull Porter Novelli Biota Holdings Limited Telephone: 61 3 9289 9555 Telephone:61 3 9529 2311