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Biotech / Medical : Biota
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To: s jones who wrote ()2/25/1999 1:54:00 AM
From: Angelo Ferraro  Read Replies (2) of 46
 
Price tumbles with the FDA voting against Relenza.

at biota.com.au

25 February 1999

Melbourne, Australia – Biota Holdings Limited announces that the Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee today voted against recommending Relenza® (zanamivir for inhalation) – a proposed new treatment for influenza type A and B – for FDA approval at this time. Relenza was invented in Australia in the 1980s and licensed to Glaxo Wellcome by Biota.

"We are disappointed with the committee's decision," noted Dr. Hugh Niall, Chief Executive Officer of Biota Holdings Limited. "Relenza is the first neuraminidase inhibitor considered by the FDA for approval. We believe that a series of international clinical trials have successfully demonstrated its ability to treat influenza. However, we are confident that Glaxo Wellcome will work with the FDA to resolve outstanding clinical issues and bring this important drug to market."

Many committee members recognised the difficulty of designing studies for this self-limiting disease. While they thought Relenza had a favourable safety profile and was a promising antiviral, they expressed reservations about efficacy in one of the three pivotal studies.

Dr. Niall added, "Regulatory approvals in other major markets around the globe are being actively pursued. Recommendations for approval of Relenza in Australia and final approval for marketing and distribution in Sweden have already been received."

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 (BTAHY) trade in the US on the pink sheets at a ratio of three shares to each ADR.
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