MELBOURNE, AUSTRALIA–(EMWNews – July 30, 2008) – Biota Holdings Limited (ASX: BTA)

today announced that its second generation, influenza treatment, CS-8958,

has successfully completed its initial Phase II clinical evaluation,

showing favourable outcomes against all measured endpoints. The initial

Phase III trial is scheduled to commence later this year. CS-8958 is a long

acting neuraminidase inhibitor (LANI), and is co-owned with Daiichi-Sankyo.

The Phase II clinical trial was designed to test the safety and efficacy of

CS-8958 in several hundred adult patients who had confirmed, naturally

acquired influenza A or B using fever and symptom resolution endpoints

after a single inhaled dose. The study was conducted in accordance with

guidance from the Japanese Pharmaceuticals and Medical Devices Agency

(PMDA). In the double-blinded trial, inhaled CS-8958 administered once only

was statistically indistinguishable from 75mg of oseltamivir administered

twice daily for 5 consecutive days. In earlier pre-clinical tests, CS-8958

has also shown efficacy against H5N1 avian influenza virus as well as

influenza A and B.

Biota and Daiichi-Sankyo are satisfied that the safety, tolerability and

efficacy data has fully demonstrated proof of concept for LANI and

therefore intend to continue with the product’s clinical development. The

Phase II results are being used to finalise the design of the pivotal Phase

III registration trial due to be conducted in the next northern hemisphere

autumn/winter influenza season. It is intended that the Phase III study be

pan-Asian and include Japan, Taiwan, Hong Kong and Korea.

A parallel Phase II study, undertaken elsewhere in Asia, has also completed

dosing. The results of both trials will be used to support the

international regulatory and development program planned for LANI.

Biota CEO Peter Cook said, “This is an important milestone for LANI. We

congratulate our partner, Daiichi-Sankyo, for a timely completion of Phase

II.”

A range of other LANI type compounds are also co-owned by Biota and

Daiichi-Sankyo and are in pre-clinical development under a grant from the

US National Institutes of Health.

About Daiichi-Sankyo

Daiichi-Sankyo Co. Ltd (TSE 4568) is one of Japan’s largest pharmaceutical

companies.

Daiichi-Sankyo has a long history of discovering new classes of drugs,

including the first-in-class statin drug for treatment of high cholesterol.

In 2003, Daiichi-Sankyo and Biota combined their LANI research programs.

About Biota

Biota is a leading anti-infective drug development company based in

Melbourne, Australia, with key expertise in respiratory diseases,

particularly influenza. Biota developed the first-in-class neuraminidase

inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza.

Biota research breakthroughs have included a series of candidate drugs

aimed at treatment of respiratory syncytial virus (RSV) disease, licensed

to MedImmune Inc. and novel nucleoside analogues designed to treat

hepatitis C virus (HCV) infections, licensed to Boehringer Ingelheim. Biota

has clinical trials underway with its lead compound for human rhinovirus

(HRV) infection in patients with compromised respiration or immune systems.

In addition, Biota has a key partnership with Daiichi-Sankyo for the

development of second generation influenza antivirals. Inverness Medical

markets Biota’s co-developed OIA FLU influenza diagnostics.

Relenza™ is a registered trademark of the GlaxoSmithKline group of

companies. BioStar® OIA® FLU and BioStar® OIA® FLU A/B are

registered trademarks of Inverness Medical.

*Further information available at www.biota.com.au.

About LANIs (Long-Acting Neuraminidase Inhibitors)

Current neuraminidase inhibitors for influenza require daily or more

frequent dosing. The ability to dose patients on a weekly, or even less

frequent, basis offers numerous benefits. Firstly, any stockpile of

weekly-dosing drug will last longer and protect more people, in the case of

an influenza pandemic. Additionally, a weekly dose may improve patient

compliance over a more frequent regime.