chugai shares have biggest fall in 2 years on tami, page-12

ann 2 feb 2005: re: next announcement ann 2 feb 2005

Firm timetable for Biota litigation against GSK
Melbourne, Australia, 2 February 2005 – Biota Holdings Limited (ASX:BTA) announced today that its suit against
GlaxoSmithKline (GSK) relating to Biota’s influenza antiviral, Relenza™, was on track and that at a hearing in the
Victorian Supreme Court on Monday 31 January, 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
31 January hearing, the court ordered GSK to file their defence against Biota’s Statement of Claim by 8 April and
to complete full discovery by 24 June 2005. This will be followed by a process of mediation required by the court,
which will occur by 25 November 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 31 January would ensure that
progress continues in this manner.
Biota filed its amended Statement of Claim on 17 December 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® diagnostics range for the rapid detection of
influenza.
Media Enquiries
Tim Duncan
Hinton & Associates
T: +61 3 9600 1979
M: 0408 441 122
™Relenza is a registered trademark of the GlaxoSmithKline