Australian News : BIOTA HOLDINGS LIMITED 1999-02-09 ASX
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10 Feb. 99 -
BTA closed @ A$8.71 up .46 = 5.6% vol. 815,432 on ASX Wednesday
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HOMEX - Melbourne
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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 |
