MELBOURNE, Australia, Feb. 1 /PRNewswire/ -- Biota Holdings Limited
(ASX: BTA) announced today that its suit against GlaxoSmithKline (GSK)
relating to Biota's influenza antiviral, Relenza(TM), was on track and that at
a hearing in the Victorian Supreme Court on Monday January 31, a firm
timetable was set for the next key phases of the litigation.
Biota is suing GSK for failing to adequately support Relenza after the
launch of the drug in 1999. At the January 31 hearing, the court ordered GSK
to file their defence against Biota's Statement of Claim by April 8 and to
complete full discovery by June 24, 2005. This will be followed by a process
of mediation required by the court, which will occur by November 25 this year.
Bruce Goldman, principal of Goldman Partners and acting for Biota, advised
that in the event mediation was unsuccessful, trial proceedings would be
likely to commence in the first half of 2006. He commented that progress with
the case to date had been excellent and that the timetable set on January 31
would ensure that progress continues in this manner.
Biota filed its amended Statement of Claim on December 17, 2004 following
a preliminary discovery phase, during which executive-level and other key
documents from GSK pertaining to Relenza were provided to Biota's legal
counsel for review. The principal allegations in the amended Statement of
Claim are:
1) GSK failed to adequately market and promote Relenza
2) GSK failed to maintain adequate inventory of Relenza to meet demand
3) GSK failed to pursue approval of the drug for prophylaxis
(prevention), and curtailed or failed to adequately perform a number
of important Phase IV studies
4) GSK failed in certain critical aspects of its Phase III studies
leading up to the approval of Relenza
5) GSK failed to develop Relenza in a commercially suitable inhaler
device
Biota CEO Peter Molloy said, "We are very confident in the merits of our
case and look forward to the full discovery phase over the next few months."
About Biota
Biota is a world-leading antiviral drug discovery company with its
headquarters in Melbourne, Australia. Biota was responsible for zanamivir, a
neuraminidase inhibitor, subsequently launched by GSK as Relenza in 1999 for
the treatment of influenza. In partnership with Sankyo, Biota is developing
second generation flu antivirals (LANI or Long Acting Neuraminidase
Inhibitors), and has discovery and development programs aimed at therapies for
diseases caused by Human Rhinovirus (common cold), RSV (Respiratory Syncytial
Virus), HIV, and hepatitis C. In partnership with Thermo Electron, Biota also
markets the FLU OIA(R) diagnostics range for the rapid detection of influenza.
SOURCE Biota Holdings Limited
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Related links:
http://www.biota-inc.com
CONTACT:
Cassandra Simmonds of Biota Holdings Limited,
+61 3 9915 3729, c.simmonds@biota.com.au; or Tim Duncan of Hinton
& Associates, +61 408 44 11 22, tduncan@hintons.com.au, for Biota
Holdings Limited
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