Immuron Ltd — Regulatory Filings 2012

Sep 18, 2012

ABN: 80 063 114 045 Level 1, 39 Leveson Street North Melbourne, Vic 3051 Tel: +61 3 8637 1107 Fax: +61 3 9328 1675 www.immuron.com

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IMMURON’S CLOSTRIDIUM DIFFICILE DEVELOPMENT PROGRAM DELIVERS POSITIVE RESULTS

• Immuron’s Clostridium difficile candidate demonstrates 100% efficacy in pre‐clinical study

• Product optimisation underway in preparation for human clinical trials

• C. difficile market estimated at $314 million in 2011 and growing*

19[th] September 2012, Melbourne, Australia : Australian biopharmaceutical company Immuron Limited (ASX: IMC), announced very encouraging results from the first of several animal studies using a novel approach to treat Clostridium difficile ( C. difficile ) infections. These results were generated ahead of schedule under the government‐ supported collaboration agreement with Monash University, which Immuron announced in January this year.

The C. difficile product used is based on Immuron’s hyperimmune colostrum production and technology platform, and as such is expected to exhibit the proven high safety profile that characterises Travelan, Immuron’s on‐market product using the same technology platform. This high safety profile and the clear market need for an effective treatment for C. difficile infections is expected to facilitate an accelerated clinical development.

During the study, mice were infected with a lethal dose of C . difficile. All mice that received Immuron’s novel treatment survived infection, and showed an overall increase in weight, as opposed to no survival for the control group that received a placebo treatment. Thus, Immuron’s product candidate protected the mice from C. difficile ‐induced disease.

The significance of this study is that both 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. The study using mice is currently being repeated to validate the first results. In parallel, optimisation of the proprietary vaccination given to the cows to produce hyperimmune colostrum is underway in order to further enhance the product in preparation for human clinical trials expected in 2013.

C. difficile is a bacterium that causes diarrhoea and serious, potentially life threatening intestinal conditions including colonic perforation and toxic megacolon. The major trigger for the development of C. difficile infection is the use of broad‐spectrum antibiotics. In light of the recent emergence of hypervirulent strains of C. difficile , there is a compelling need to develop novel preventive and treatment strategies to combat infections. The “Global Markets Direct (2011)” report supports the lack of effective treatment options in this market.

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

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 (Global Markets Direct, 2012).

"We are encouraged by the positive data and the rapid development progress" said Mr Joe Baini, CEO of Immuron Limited. "Since the mouse model is an appropriate human disease model, we expect that the results generated to date should also be seen in humans. We believe these results provide a solid foundation for progressing development of our C. difficile product towards human clinical trials."

“The results to date are very promising, and we hope to provide further data validating these initial results over the coming months,” said Associate Professor Dena Lyras, lead investigator for the project at Monash University. “Furthermore, it is our intention to develop a product that not only prevents symptoms, but also prevents transmission of this debilitating and life‐threatening disease.”

• Global Markets Direct Report 2012

Contact

Joe Baini – Chief Executive Officer

+61 3 8637 1107

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 hyperimmune colostrum platform technology has the potential to offer a new‐paradigm effective therapeutic.