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Immuron Ltd Regulatory Filings 2006

Jul 12, 2006

35121_rns_2006-07-12_f50e9dea-67f3-42a0-aa6e-2c66ea73a0a5.pdf

Regulatory Filings

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July 13th, 2006

Company Announcement Office Australian Stock Exchange Ltd (ASX) 4th Floor, 20 Bridge Street Sydney NSW 2000

Dear Sir/Madam

Please find herewith a company announcement "EV-71 Cattle Vaccine Receives Regulatory Approval"" for release and distribution to the market immediately.

Yours sincerely

CONOR GRAHAM Managing Director & CEO

Key Regulatory Approval Received for Enterovirus 71 Program

Anadis is pleased to inform its shareholders and the public of the successful receipt of approval from the appropriate government authorities, for the commercial scale use of the Anadis Enterovirus-71 vaccine in cattle.

The Enterovirus-71 (EV-71 or Hand, Foot & Mouth disease in Children) project is one of high commercial significance to Anadis, offering the potential to contribute significant revenue commencing during the 2006/07 financial year.

The commencement of the EV-71 "hyper-immunisation" program has occurred as a result of significant and successful interaction between Anadis Limited, AQIS (Australian Quarantine Inspection and Service) and APVMA (Australian Pesticides & Veterinary Medicines Association) whereby both independent Government bodies have granted approval.

The program, which began this week, is expected to deliver antibodies, starting late August. Anadis is currently on schedule to deliver protection to the children of Taiwan, and ultimately the Asia region, in the form of an anti-EV-71 antibody rich product in time for the northern hemisphere summer of 2007.

Anadis continues to actively work with key organizations in Taiwan to ensure that product registration, marketing and distribution will be ready in this timeframe.

EV-71 Preventative Production & Commercialisation Timeline

Recently, Enterovirus-71 has tragically reached epidemic proportions in the Malaysian state of Sarawak, with the disease afflicting over 10,800 children, with 11 fatalities, and over 40 new cases reported daily.

Anadis is preparing to meet Malaysian authorities during July to discuss distribution opportunities.

The Board would like to thank Mr. Brian Muller, Manager of Regulatory Affairs, for his commitment and efforts during this complex approval process and the vaccine manufacturing team headed by Dr. David Delaney.

EV-71 Project Background

During November 2002, Anadis signed a development and manufacturing agreement with the Taiwanese Development Centre for Biotechnology (DCB) for the development of a preventative therapy against Enterovirus 71. The concept was to develop a hyper-immune colostrum antibody based preventative which, when taken daily during the high risk period (summer months), would provide a "suit of amour" against an infection. The DCB had estimated a dosage requirement at a conservative 30-35% penetration of the potential market in Taiwan - this equated to over 110 million doses per annum.

By mid August 2004 – less than 2 years later – Anadis had developed a laboratory scale protective therapy against Enterovirus 71, an almost unheard of achievement in terms of development time.

In June 2005 Anadis announced the successful obtaining of bioactive proteins against Enterovirus 71 from cows – commercial quantity scale up was proven to be possible.

About Enterovirus 71

Enterovirus 71, a polio like disease, is one of the viruses that cause 'hand, foot and mouth' or 'slapped cheek' disease in young children. Mild symptoms usually include a rash and quieter than normal behaviour, while a significant proportion of younger children can develop nervous signs such as fits, paralysis and even death. Fatalities can occur for approximately one quarter of the children affected by the severe form of the disease.

Although not well known Enterovirus 71 is a major problem in the Asia-Pacific region -in particularly Taiwan and China - outbreaks have also been reported in Hong Kong, Vietnam, Malaysia and Singapore

During 2005, Enterovirus 71, was responsible for the infection of over fifty children with the severe form of the disease and the tragic death of five. Enterovirus 71 is an emerging 'disease state', and the World Health Organisation are comparing the disease with the spread of polio in Europe and North America in the late 19th century.

About Anadis Limited:

Anadis, a Melbourne based biopharmaceutical company is focused on Nutraceutical and Pharmaceutical research and development. Anadis is a specialist in the development of bovine colostrum derived products for therapeutic use in humans. Projects include:

Anadis' first commercialised product: Travelan is a natural product, which significantly decrease the risk of the medical condition known as Travellers Diarrhoea and the symptoms of gastrointestinal disorders. Travelan is a bovine colostrum preparation, prepared from cows hyper-immunized against the 13 most common strains of $E_{\text{col}}$ – the most common cause of Travellers Diarrhoea (Bali Belly, Delhi Belly, etc.).

Travelan has recently received a "Green Light' for sales in the US and a distributor in Canada has been appointed. Travelan is being considered for other markets including: Singapore, India, Korea, United Arab Emirates, Thailand, Malaysia, South Africa and the UK and EU.

Travelan has recently been potentially identified for additional gastrointestinal indications including Irritable Bowel Syndrome IBS and Inflammatory Bowel Disorder IBD.

For more information please visit www.travelan.com.au

$EV-71$ - a bioactive protein based preventative product against Enterovirus 71, a debilitating polio like disease, is one of the viruses that causes 'hand, foot and mouth' or 'slapped cheek' disease. A significant proportion of younger children effected can develop nervous signs such as fits, paralysis and Enterovirus 71 has the potentially to be fatal.

A set of Bio-Warfare/Respiratory Protection technologies, a project in conjunction with the Australian Department of Defence and US Bio-Defence Organisations, initially focused on short-term immediate protection from airborne bacteria such as Anthrax and Plague, future civilian applications include Hay Fever and Asthma.

Bio-Shield 10 a range of "bio-shielding" technologies which protect delicate molecules, enzymes and proteins, initially targeted for use in the pro-biotic market.

Development into an Immune Stimulating Infant Formula is underway, initially destined for the Asian market.

Pyloran, which has been clinically proven to reduce levels of H.pylori bacteria in the stomach and reduce the symptoms of H.pylori associated gastritis - Anadis is also in early development of a H.pylori vaccine.

For further information, please contact:

Conor Graham - Chief Executive Officer Email: [email protected] +61 3 9358 6388 Arie Nudel - Investor Relations Email: [email protected] +61 3 9358 6388

Visit our websites: www.anadis.com.au and www.travelan.com.au

Anadis - Delivering On The Promise Of Biotechnology