Relenza Lawsuit Boosted by UK Flu Stockpiling
MELBOURNE, Australia, March 4 /PRNewswire/ -- Biota Holdings Limited
(ASX: BTA) announced that the recent decision by the UK Government to
stockpile nearly GBP200 million of flu antivirals again overlooked
Relenza(TM), and further demonstrates the potential that Biota's antiviral
Relenza would have if properly supported by its licensee GlaxoSmithKline
(GSK). It also boosts the potential market for a new generation of flu drugs,
which are currently in development by Biota.
On 1 March, the UK Government indicated its intention to purchase
14.6 million units of oseltamivir (Tamiflu(TM)) over two years. The decision
was in response to growing fears about bird flu and the increasing risk of a
global flu pandemic.
"The UK stockpiling decision reinforces our claim against GSK for damages
associated with their failure to support Relenza," said Biota CEO, Peter
Molloy. "Relenza is an effective drug that was first to market, but was
shelved by Biota's marketing partner despite their commitment to support the
product."
Biota licensed zanamivir exclusively to Glaxo, now GSK, which launched the
drug in 1999 under the tradename Relenza. However, after its merger with
SmithKlineBeecham in 2000, GSK curtailed support for Biota's drug and the
product's market share declined dramatically. Relenza currently holds less
than 1% of the world market for flu antivirals. Both Relenza and its
competitor, Tamiflu, are considered to be effective against avian flu strains
and both have been recommended by health authorities for use in the management
of pandemic influenza.
In May 2004, Biota filed a lawsuit against GSK in the Supreme Court of
Victoria in Australia, claiming that their failure to support Relenza caused
Biota substantial losses, especially in the face of the now growing flu
antivirals market. Following a preliminary discovery phase in the second half
of 2004, Biota filed its amended Statement of Claim in December 2004. In
January 2005, the Court laid down a timetable for the suit, stipulating
completion of full discovery by the end of June 2005 and mediation in November
2005. If the case is not settled by mediation, a trial could follow during
2006.
In conjunction with Sankyo Co Ltd of Japan, Biota is also developing a
second generation of flu antivirals called LANI (longacting neuraminidase
inhibitors) for the treatment and prevention of influenza. Recently, Biota
received a US$5.6 million grant from the US National Institutes of Health
(NIH) to accelerate the development of LANI because of the drug's perceived
potential as a first line of defence against bird flu and other potential
pandemic flu strains. The UK stockpiling decision should boost the prospects
for LANI.
"The UK order significantly increases the size of the global market for
flu antivirals," said Biota CEO, Peter Molloy. "It augurs well for the
prospects of our new long-acting flu drugs."
The world market for the flu antivirals was previously estimated by Biota
at approximately A$500 million (GBP200 million) pa. The UK order suggests the
potential world market could be much larger.
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 |
