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Immuron Ltd Regulatory Filings 2012

Dec 16, 2012

35121_rns_2012-12-16_8f9528f5-38b7-4a4a-b879-a76b43b346c3.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 Fax: +61 3 9686 9460 www.immuron.com

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ADDITIONAL RESULTS TAKE IMMURON’S CLOSTRIDIUM DIFFICILE PRODUCT DEVELOPMENT FORWARD

  • Validation from further pre‐clinical studies

  • Data demonstrates Immuron’s therapeutic candidate eliminates symptoms and reduces transmission in mice

  • Product optimisation underway in preparation for human clinical trials

  • C. difficile market is poorly met with potential to grow

17 December 2012, Melbourne, Australia : Australian biopharmaceutical company Immuron Limited (ASX: IMC), announced encouraging results from additional animal studies using its novel approach to treat Clostridium difficile ( C. difficile ) infections. The studies, conducted under the government supported collaboration with Monash University, validate the results announced earlier this year. Immuron’s product is aimed at both preventing transmission as well as treatment of C. difficile infection. This dual mechanism is unique.

C. difficile is a bacterium that causes diarrhoea, leading to colitis and other serious, potentially life threatening, intestinal conditions; there are no effective treatment options on the market. The annual global C. difficile product market was estimated to be $314 million in 2011, and is forecast to grow at a CAGR of 6.0% to more than $500 million by 2019.*

The C. difficile product being developed by Immuron is based on the company’s hyperimmune colostrum production and technology platform. During the study, mice were infected with a lethal dose of C . difficile. As with the earlier results, mice that received Immuron’s novel treatment, survived infection, and showed an overall increase in weight. There was no survival for the control group that received a placebo treatment. Furthermore, one arm of the study demonstrated a reduction in the number of spores found in the mice faeces, suggesting that transmission was also reduced.

Since the infectious cycle and the type of disease seen in mice is similar to that seen in humans, and it is known that the C. difficile toxins cause the same devastating effects in both species, the study model and the positive results support Immuron’s preparation for human trials. Optimisation of the proprietary vaccine used to produce the specific hyperimmune colostrum is continuing – this will further enhance the product in preparation for human clinical trials expected in late 2013.

Based on Immuron’s strong preclinical data, the Company’s hyperimmune colostrum‐based product may prove to be an effective preventative and treatment.

* Global Markets Direct, 2011

Contact

Joe Baini – Chief Executive Officer +61 3 8648 4530

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 influenza. Immuron has one product in the market, Travelan, for preventing travellers’ diarrhoea. Immuron’s main scientific alliances are with Hadassah Medical Center (Israel), the University of Melbourne and Monash University (Australia).

About Clostridium difficile

C. difficile infections have become a major medical problem especially in hospitals and long‐term care facilities because the bacteria produce toxins that cause inflammation of the colon, causing severe diarrhoea and, in serious cases, death. An estimated 28,000 people die each year from these infections in the USA, and numbers have significantly increased over the last decade. C. difficile infections result in an estimated annual economic burden of more than US$10 billion globally. Current therapies are based on antibiotics that are not fully effective and that encourage the emergence of antibiotic‐resistant strains, Immuron’s hyper‐immune colostrum platform technology has the potential to offer a new‐paradigm effective therapeutic.