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LANI completes Phase I in Japan and to commence Phase I in UK

Melbourne, Australia — 19 April 2007- Biota Holdings Limited (ASX:BTA) today announced that its long acting neuraminidase inhibitor (LANI), CS8958, an anti-influenza treatment, has:

1. demonstrated effectiveness against the avian flu virus H5N1;
2. completed Phase I studies in Japan; and
3. received ethics approval to commence comparable studies in the UK.

Biota’s partner for LANI, Daiichi-Sankyo, overnight announced that laboratory
studies had confirmed CS8958’s effectiveness against the avian flu virus H5N1 in
addition to its effectiveness against influenza A and B type non-avian viruses.
Daiichi-Sankyo also announced that it has completed a Phase I clinical trial in Japan
on CS8958 and expects to start Phase II studies in October.

The UK studies will extend the safety and pharmacokinetics studies of CS8958 in
man. The double-blinded study will involve up to 40 healthy volunteers using a
single dose, and will trial up to four separate, single dose levels. The study is being
funded as part of a US$5.6 million grant provided by the US National Institutes of
Health. The studies will utilise a newly licensed inhaler designed by Hovione and
complement the studies completed by Daiichi-Sankyo in Japan. The UK studies will
generate data in western subjects and lay the basis for further clinical development
outside Japan.

CS8958 is a long acting neuraminidase inhibitor and offers higher potency, lower
dose and the potential for once only treatment and once weekly prophylactic
protection from influenza. These properties are known consumer advantages over
existing inhaled and oral therapies.

CS8958 and a range of other LANI type compounds are co-owned by Biota and
Daiichi-Sankyo.

Biota CEO, Peter Cook said “These are important milestones in the development of
second
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TAG: LANI completes Phase Japan and commence Phase
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