BIOTA HOLDINGS LIMITED 1999-04-08
HOMEX - Melbourne
Biota Holdings Limited advises that its development partner, Glaxo
Wellcome plc, has been notified by the US Food and Drug
Administration (FDA) of their intention to continue the regulatory
review of the application of the company's influenza product, Relenza
(zanamivir), beyond the April 27th action date.
Under US law, companies pay a user-fee to the FDA with each drug
application. In return, the FDA aims to complete the review of the
application, by a specified date, which in this case was April 27th.
This extension will allow the company and the FDA more time to
continue their review of the data on Relenza and follows discussions
between Glaxo Wellcome and the FDA after the February 24th meeting of
the agency's Antiviral Drug Advisory Committee, which did not
recommend approval.
Glaxo Wellcome has already received approval for Relenza in Australia
and Sweden. Sweden is acting as the Reference Member State in the
Mutual Recognition Process for the purpose of obtaining approval in
the other countries of the European Union.
Relenza is the first of a new generation of drugs known as
neuraminidase inhibitors. Its mode of action is to prevent the
spread of infection from one cell to another within the respiratory
tract. Relenza is delivered via an inhaler, direct to the airways
where the virus replicates.
Glaxco Wellcome is a research-based pharmaceutical company whose
people are committed to fighting disease by bringing innovative
medicines and services to patients throughout the world and to the
healthcare providers who 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 cancer and viral respiratory
disease. The company's ADRs trade in the US (BTA-HY) on the pink
sheets at a ratio of three shares to each ADR.
For further information, please contact:
Richard Wadley Elizabeth Field/Michael Moore
Chief Financial Officer Turnbull Porter Novelli
Biota Holdings Limited Telephone: 61 3 9289 9555
Telephone: 61 3 9529 2311
Biota's announcements may be found on their website at
www.biota.com.au |
