Immuron Ltd — Regulatory Filings 2007

Aug 5, 2007

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Company Announcement

Anadis and ImmuCell to Cross-License Antibody Technologies

Monday 6 August 2007

Anadis Limited (ASX: ANX), a research-driven biotechnology company focused on polyclonal antibody technology, announced today that it had signed a heads of agreement with ImmuCell (NASDAQ: ICCC), a biotechnology company headquartered in Maine, USA.

Under the heads of agreement, Anadis will license from ImmuCell a portfolio of issued patents, IND filings, clinical data, manufacturing plans and know-how related to several human heath product lines.

The deal for the licensing is royalty-based and requires no upfront or milestone payments. These technologies are expected to significantly accelerate Anadis’ plans addressing Biodefence, enteric and nosocomial (hospital acquired) disease areas, including Clostridium difficile. Additionally the licensed technologies could be used to broaden the efficacy of Anadis’ diarrhoea preventative Travelan™.

Anadis will provide ImmuCell with access to manufacturing infrastructure and know-how related to its HIDDA (Hyper-Immune, Dairy Derived Antibody) platform to address veterinary applications, and will thereby enable ImmuCell to introduce its own veterinary products into Australia and New Zealand. The agreement is expected to yield revenue for Anadis during the period prior to the launch of the planned products, in addition to manufacturing and royalty revenue from the products marketed under ImmuCell’s own name. Royalty-bearing marketable products for the veterinary market are expected to be launched within two years.

The agreement represents another milestone in the significant changes undertaken by Anadis in recent months. The company is leveraging its broad intellectual property portfolio, significant research and development capabilities and production infrastructure in the field of dairyderived antibodies, to reach significant collaborations with academic and industrial partners.

Dr Zeil Rosenberg, CEO of Anadis Limited, said: “This agreement will be instrumental in the significant organisational processes we are conducting at Anadis to better execute our business model. It is another testimony of our unique position in the market place – combining a decade of research and development of manufacturing know-how in the field of polyclonal antibodies with market-driven opportunities.”

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Dr Rosenberg added: “The ImmuCell agreement is another important piece in the strategy Anadis is developing. We continue in our pursuit to become the world’s leading provider of polyclonal antibody-based solutions. The result of years of thorough R&D work is starting to yield synergistic results. We are now on an aggressive commercialisation pathway, deriving royalty, product and custom-solutions revenue, while at the same time fortifying our intellectual property portfolio.”

Further information about ImmuCell can be found at www.immucell.com

For further information contact:

Dr Zeil Rosenberg (US) - CEO Email: zeil.r@anadis.com.au Tel: +1 201 750 4799

Arie Nudel – Investor Relations Email: arie.n@anadis.com.au Tel: +61 3 9358 6388

Richard Allen – Media

Email: richard@oxygenpr.com.au Tel: +61 3 9915 6341

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About Anadis Limited:

ANADIS – Antibodies against Disease

Anadis Ltd. (ASX: ANX) is a biotechnology company focused on antibody-based therapeutic and preventive products with a product pipeline addressing existing market opportunities sized in excess of US $30 billion. All products in the company’s pipeline are expected to reach the market over the next five years Current R&D pipeline targets address broad markets including influenza, oral mucositis, nosocomial infections, enteric diseases, biodefence, functional foods and oncology.

Anadis’ proprietary rapid development and manufacturing technology, the HIDDA platform (Hyper-Immune, Dairy-Derived Antibodies) provides Anadis with significant competitive advantages in the development of proprietary polyclonal antibody-based solutions to a broad range of infectious and immune-mediated diseases.

Short Time to Product: May require as little as 3-6 months to obtain new antibody formulations for clinical testing and use.

Rapid Scale up: With access to enormous numbers of dairy animals, large-scale rapid production is feasible and cost-effective.

Cost Advantage: Dairy-derived immunoglobulins are a fraction of the cost of serum-derived monoclonal antibodies and may provide a more robust immune response.

Shorter Regulatory Pathway: The antibodies are purified and formulated from colostrum (firstmilking) of dairy cows which have been immunized with proprietary vaccines and then carefully tracked for safety. Anadis’ HIDDA-based pipeline products are typically classified as medical food and have a much shorter and less costly path to commercialization than comparable pharmaceutical products.

Platform based: Proven ability to raise and harvest a broad range of antibodies against bacteria, viruses and toxins for delivery to the gastrointestinal tract, the upper respiratory tract and topically as required.

Leveraging a technology platform that has been developed over a decade by leading medical research institutions, the company expects to become the leading provider of proprietary polyclonal antibody-based solutions worldwide within five years.

Pipeline

Target markets exceed US$30 billion and include both proprietary products the company plans to manufacture itself as well as out-license, respectively. The pipeline is expected to reach the market over the next five years:

• Influenza – Immediate-acting prevention and treatment of pandemic and seasonal influenza. The Anadis HIDDA platform allows for rapid modifications of the antibody profile in order to address new, emerging strains (e.g. avian influenza). Access to a specialized government high containment research unit including highly lethal H5N1 avian influenza strains will aid rapid product development.

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• Oral Mucositis A common and potentially serious side effect of high-dose chemotherapy (CT) and/or radiotherapy (RT) regimens often manifested as painful ulcerative lesions of the mouth and throat. Target market includes more than 5 million patients.

• Bio-Defense – Environmental pathogen diagnosis, containment decontamination Funded by the Australian Defense Department Science and Technology Office (DSTO), this emergency response system is based on a proprietary antibody/ polymer hydrogel combination for the rapid identification and containment of anthrax, plague and other bio-warfare agents.

• Nosocomial infections Prevention and treatment for top priority hospital and community acquired nosocomial infections, in particular Clostridium difficile.

• Enteric disease conditions including

  • Travelers’ Diarrhoea (TD) (enterotoxigenic E.coli). This product, Travelan, was

  • introduced to the market as a proof of concept of the platform and is being sold in Australia, Canada and other countries

  • Irritable bowel syndrome (IBS), suffered by more than 10% of the world’s population.

  • Inflammatory bowel disease (IBD) A clinical study for use as an adjunct therapy in

  • patients with IBD started in ‘07 and is being expanded to a multi-center study.

• Functional Food HIDDA permits freeze-drying of proteins and vaccines onto dry food enabling use of dairy derived antibodies as functional food. Anadis has announced an R&D collaboration with Coca Cola Australia to commercialize a few derivatives of the technology.

• Oncology Anadis is in final stage of negotiations with several major cancer research groups to develop HIDDA based oncology treatment approaches, initially addressing Liver cancer.

• BioShielding – Proprietary oral drug delivery technology Originally developed for Anadis’ own products, this approach protects orally administered and pH sensitive drugs, antibodies and vaccines from degradation during passage through the harsh acid conditions found in the stomach, facilitating absorption or immunization in the gut. This technology may allow reformulation of numerous products already in the market, increasing their efficacy or permitting oral delivery.

Visit our website: www.anadis.com

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