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Immuron Ltd — Regulatory Filings 2013
Nov 12, 2013
35121_rns_2013-11-12_becfc8fa-da19-4cec-9d0c-66a2646504f8.pdf
Regulatory Filings
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ABN: 80 063 114 045 Level 1, 18 Kavanagh Street Southbank, Vic 3006 Tel: +61 3 8648 4530 www.immuron.com
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IMMURON’S TRAVELAN APPROVED FOR MARKETING IN CANADA
Melbourne, Australia, 13 November 2013: Australian biopharmaceutical company Immuron Limited (ASX: IMC), today announced that its Canadian partner for Travelan®, Paladin Labs Inc., has received from Health Canada a Product License authorizing the sale of Travelan in Canada. Similarly to the Australian listing for Travelan, the authorization granted to Paladin Labs is for tablets comprising 200mg of Immuron’s anti-ETEC hyperimmune bovine colostrum.
In Canada, Travelan is classified as a Natural Health Product and will be available to patients over-thecounter, without the requirement to obtain a prescription. The authorization for Travelan in Canada entitles Paladin Labs to claim on the product package that it is Clinically Proven to Help Reduce the Risk of Travellers’ Diarrhea.
Immuron’s Chief Executive Officer Amos Meltzer said: “We are delighted that Paladin Labs has secured approval to commercialize Travelan in Canada. We know that the Travelan team at Paladin has worked tirelessly to obtain the authorization and we have confidence that Paladin’s expertise will underlie the successful commercialization of Travelan in Canada, which similarly to Australia, is a nation of many international travellers. As we continue to expand the Travelan global franchise, the approval of Travelan in Canada represents a significant milestone for Immuron and we look forward to continuing our good working relationship with Paladin. We expect that approval for Travelan in Canada will be followed by additional licensing agreement product approvals in other territories.”
Contact
Amos Meltzer – Chief Executive Officer +61 437 587 680
About Travelan
Travelan is a natural product which is specifically designed to reduce the risk of infection by ETEC, the most common cause of Travellers’ Diarrhea. In clinical trial Travelan showed protection of up to 90% efficacy against infection with the type of E.coli that causes travellers’ diarrhea. In addition, trials showed a significant reduction in abdominal cramps and stomach pain compared to those who did not receive Travelan. There were no reported treatment related side effects in the clinical trials.
About Immuron Limited
Immuron is a biopharmaceutical company focused on oral immunotherapy treatments using dairy-derived antibody products for humans. Immuron is uniquely positioned with a versatile technology platform capable of generating a wide range of products with a high safety profile. This high safety profile makes it possible to complete pre-clinical studies relatively quickly and increases the prospect that the clinical development of Immuron’s products will be expedited. Immuron’s current products and product candidates target infectious diseases of the gastrointestinal tract, chronic diseases such as fatty liver (NASH), and the prevention of influenza. Immuron has one product in the market, Travelan, for preventing travellers’ diarrhoea. Immuron’s main scientific alliances are with Hadassah Medical Center (Israel) and Monash University (Australia).