AI assistant
Immuron Ltd — Regulatory Filings 2004
Aug 16, 2004
35121_rns_2004-08-16_2123af85-2e91-4474-9573-bc106c94dbc6.pdf
Regulatory Filings
Open in viewerOpens in your device viewer

August 16th 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 "Travelan Update" for release and distribution to the market immediately.
On Behalf Of ANADIS LIMITED
CONOR GRAHAM Managing Director & CEO
Travelan Update
Travelan
This announcement will help to clarify any questions, and rectify any misconceptions, that investors and potential customers may have regarding Travelan - the first ever product to significantly reduce the risk of travelers diarrhoea.
- Travelan, after comprehensive review, has recently passed registration by the Australian Therapeutics Goods Authority (TGA) and received an Australian Listing Number ("L" number).
- The formulation of Travelan has changed since its initial composition, including the removal of Citrus x Paradisi, always in an effort to improve the final product.
- The formulation of Travelan, as a result of dialogue with the TGA, was changed in a minor way to ensure that TGA natural product rules were not violated $-$ as Travelan is a natural product.
- This change involved the removal of an anti-bacterial component (Citrus $x$ ) Paradisi). This component is accepted in many markets, including the USA, where it has been marketed since the 1950s and is "Generally Regarded As Safe" by the US FDA. However, under recent TGA policy, the component failed to meet natural product guidelines. The removal of this component has not affected the benefits claimed for Travelan.
- The removal of Citrus x Paradisi was able to take place due to $\bullet$ improvements in vaccine, manufacture and delivery technologies and after efficacy and extensive review of existing stability data. Importantly these improvements are:
- o Advances in dairy hygiene during manufacture (Anadis and Tatura Milk Industries patented Tatura Anadis Colostrum Harvesting System (TACHS)).
- o Advances in vaccine technology (Surface Antigen Shearing, Anadis patent pending)
- o Advances in delivery technology (Anadis' BioShielding technologies, patent pending)
- Mode of Action studies performed over the last 2 years, showed that $\bullet$ Travelan efficacy is due to the Antigen (E.coli) ? Antibody (Colostrum Powder) reaction, and not the bacteriocidal (Citrus x Paradisi) effect.
Travelan now has natural product credentials accepted by the Australian $\bullet$ TGA - one of the most stringent drug regulatory bodies in the world. All product claims are scientifically proven and in accordance with the TGA's guidelines of evidence for claims in complementary (natural) medicines.
Timeline for Travelan Victorian Release
Initial production of tablets is underway (63,000 packs) due for completion week ending $28th$ August 2004.
Initial packs will be available within selected pharmacies in early September 2004.
Final packaging of all tablets by the week ending $25th$ September 2004.
Between now and final packaging distributors and distributor representatives will be trained, pharmacy buyers approached and orders taken from selected pharmacies. In a normal representative selling cycle, each chemist/pharmacy will receive a detailed presentation of the Anadis offering. This includes promotional material, advertising schedule, frequently asked questions (FAO) etc.
Media launch begins at the start of October 2004, including print media and radio advertising, to coincide with the full Victorian launch.
Anadis is aiming for full Australian launch by the end of first quarter 2005.
Current hyper-immunisation of over 2.400 cows is now completed, with collection due to commence end of August 2004, this equates to approximately 350,000 packs.
Anadis - Delivering On The Promise Of Biotechnology
For more information please contact: Conor Graham - Managing Director & CEO Email: [email protected] $\alpha$ r Arie Nudel - Investor Relations Email: [email protected]
Tel: +61 3 9358 6388 Fax: +61 3 9358 6399