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Immuron Ltd — Regulatory Filings 2004
Aug 18, 2004
35121_rns_2004-08-18_352c79c8-4c1d-47cb-afa5-e4a968ae7ec5.pdf
Regulatory Filings
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August 19th, 2004
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 "Enterovirus 71 Research Success" for release and distribution to the market immediately.
On Behalf Of ANADIS LIMITED
CONOR GRAHAM Managing Director & CEO
Enterovirus 71 Research Success
Anadis Limited (ASX:ANX) is pleased to announce the development of a protective therapy against Enterovirus 71 (EV71). This project is the result of a successful joint venture with the Taiwanese Development Center for Biotechnology (DCB) that began in November 2002.
It has been proved that the methodology developed by Anadis and DCB will provide effective candidate materials for controlling EV71.
The joint Anadis / DCB Scientific Steering Committee for this project have agreed that the scientific / laboratory phase has been successfully completed, and have therefore recommended that the project be advanced to both production scale-up and commercialisation
For effective protection, each young child will take one dose of the protective therapy per day during the annual 3 month high risk period. DCB anticipates the market in Taiwan alone to be in excess of one hundred and ten million doses per annum.
The EV-71 project is one of major commercial significance to Anadis. Under the terms of the agreement, Anadis receives exclusive global manufacturing rights for the bioactive materials and for the finished product for a minimum of five years. Anadis additionally receives on going royalties from all sales in Asia, and sole distribution rights for all markets outside Asia. Further, Anadis is in discussions with DCB aimed at giving Anadis a significant role in the marketing of this product in Taiwan, potentially further enhancing returns for Anadis' shareholders.
During the research phase of the project the research team needed to overcome substantial technical hurdles including:
- Development of high yielding virus growth protocols.
- Coordination of regulatory work to conform to AQIS $\blacksquare$ (Australian Ouarantine & Inspection Service) and APVMA (Australian Pesticides & Veterinary Medical Authority) guidelines.
- Development of a multi-stage virus inactivation procedure to ensure safety and regulatory acceptance.
- Development of a suite of appropriate in vitro trial protocols.
- Clarification of preferred production strategies.
Currently a consolidation of intellectual property is taking place $-a$ new provisional patent application is in preparation, with joint ownership by Anadis and the DCB. More detailed scientific information will be made available to the market, post the lodging of the patent.
Anadis estimates an 18 to 24 month lead time until the first doses are available for sale in Taiwan
Background:
Enterovirus 71, a polio like disease, is one of the viruses that causes 'hand, foot and mouth' or 'slapped cheek' disease in young children. Mild symptoms usually include a rash and quieter than normal behavior, 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.
Enterovirus 71 isn't as yet well known in Australia, however in the Asia-Pacific region – mainly Taiwan and China – major outbreaks are becoming increasingly common. Enterovirus 71 is an emerging 'disease state', and medical authorities are comparing the disease with the spread of polio in Europe and North America in the late 19th century. Outbreaks of Enterovirus 71 are mainly confined to Asia but have recently been reported in Europe and Australia.
Anadis would also like to welcome our new Senior Virologist Dr David DeLaney who joins our team for the commericalisation of the EV71 project.
Anadis - Delivering On The Promise Of Biotechnology
Anadis Ltd is a Melbourne based biopharmaceutical company, focusing on Nutraceutical and Pharmaceutical products derived from bovine colostrum. Travelan, the first ever Travelers Diarrhea preventative, is being released into the Australian market during September 2004. Travelan has been proven in hospital clinical trials to significantly decrease the risk of Travelers Diarrhea and the symptoms of gastrointestinal disorders. Travelan is prepared from bovine colostrum, from cows hyper-immunized against the 14 most common strains of $E_{\text{c}}$ coli – the most common cause of Travelers Diarrhea and works through the process of passive immunity transfer.

Other Anadis projects include Pyloran, which has been clinically proven to reduce infection and symptoms of $H.pylori$ associated gastritis; Bio-Shield 10 a range of "bio-shielding" technologies that protect delicate molecules, enzymes and proteins, initially targeted for use in the pro-biotic market, and Respiratory Protection technologies, a project in conjunction with the Australian Defence Forces and US Bio-Defence Organisations, initially focused on short-term immediate protection from airborne bacteria such as Anthrax and Plague, future applications include Hay Fever and Asthma. Anadis is also in early development of a H.pylori vaccine.
For more information please contact:
Conor Graham Managing Director & CEO Email: [email protected]
$OI$
Arie Nudel - Investor Relations Email: [email protected]
Tel: +61 3 9358 6388 Fax: +61 3 9358 6399