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Immuron Ltd — AGM Information 2009
Nov 22, 2009
35121_rns_2009-11-22_49d5f311-ab52-457c-a292-a744d09a15fc.pdf
AGM Information
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23 November 2009
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ASX Release
Immuron Limited ABN 80 063 114 045
Corporate Details:
ASX Code: IMC OTCQX Code: IMROY (U.S.)
Annual General Meeting Chairman’s Address and Presentation by Dr Grant Rawlin and Distribution Agreement with Nycomed Australia
Directors:
Chairman:
Prof. Colin Chapman Non-Executive Directors: Prof. Roy Robins-Browne Mr. Arie Nudel Mr. Simon Sallka Dr Elane Zelcer
General Manager Research & Development
Dr Grant Rawlin
| Substantial Shareholders: | |
|---|---|
| Hadasit Medical Research | 19.8% |
| Capital Concerns Pty Ltd | 5.19% |
| Alaven Consumer H’care | 3.8% |
| Tatura Milk Industries | 2.7% |
Contact Details:
Attached are copies of the Chairman’s address and the presentation by Dr Grant Rawlin, Chief Executive Officer, which will be made to the Annual General Meeting of shareholders this morning.
Immuron also announces that it has entered into a heads of agreement with Nycomed Australia Pty Ltd for Nycomed to become the exclusive distributor of Travelan in Australia and New Zealand.
Nycomed have also indicated that they will consider introducing Travelan to other countries in which they operate throughout the world. That arrangement will be subject to separate agreements.
Nycomed Global is a privately owned company based in Switzerland and is one of the top 25 pharmaceutical companies, and is the15th top OTC company in the world.
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Graeme Stevens Company Secretary
Immuron Limited Level 1 39 Leveson Street North Melbourne VIC 3051 Australia
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Chairman’s Address to Annual General Meeting 23 November 2009
Good morning ladies and gentlemen.
It is my pleasure to welcome you to the 2009 Annual General Meeting of Immuron Limited.
I’m sure you know that it has been a busy year for the Company:
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There have been significant changes in the Company’s Board and management structure.
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There was a very successful capital raising.
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Important links with the Hadassah Medical Centre have been established
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Moves have been made to enhance the market ‘reach’ of Travelan.
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Several interesting and commercially-relevant research and development projects have commenced.
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And of course we changed our name from Anadis to Immuron.
Board Membership and Management Structure
Membership of the Board of Management changed during the year: Dr Peter Jenkins resigned in February 2009 after a long period of active and constructive involvement with the company, including a period as Chairman from July 2008 to February 2009.
I rejoined the Board in June 2008 after having been an original member when Anadis was first established, and was subsequently elected chairman in February 2009.
Dr Elane Zelcer was appointed to the Board in November 2009 as a representative of Hadasit.
There were also some significant changes in management team: Dr Zeil Rosenberg was not re-appointed as Chief Executive Officer (CEO) after several extensions of his contract, and this was announced to the ASX in May 2009.
I took on the role Executive Chairman until the Company appointed a new CEO. Dr Grant Rawlin, previously General Manager, Research and Development, was appointed CEO in November 2009.
Capital Raising
A very significant achievement during 2009 was the successful capital raising. I wish to sincerely thank the shareholders who contributed to the SSPP, and the new shareholders who made this raising of much-needed additional capital so successful. A significant portion
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of the funds raised will used to meet the projected research and development expenditure associated with the very important links with the Hadassah Medical Center in Jerusalem. Some of the funds raised will be used to fund new research and development projects.
Hadassah Medical Center
As indicated previously a significant proportion of the funds raised will allow Immuron to embark on exciting new research and development projects, in conjunction with Hadasit, through the Hadassah Medical Center. A key link has been established with Professor Yaron Ilan and his team at Hadassah, and both Dr Grant Rawlin and I have visited Israel to participate in the planning stages of several exciting projects.
Hadasit promotes and commercialises the intellectual property, along with the research and development capabilities associated with Hadassah’s physicians and scientists.
Immuron has acquired some specific technology and patents developed and registered by Professor Ilan and his team, and Professor Ilan has been appointed the company’s Medical Director to facilitate ongoing aspects of Immuron’s product development work.
The technology and patents acquired relate to the findings that oral administration of antigenspecific colostrum is particularly effective in influencing the immune system through actions on T regulatory cells, more so than antibodies alone, to exert control over the body’s immune response – particularly when such responses are known to be defective and/or misdirected in many infectious, inflammatory and malignant disorders.
The initial targets for the research and development work to be performed at Hadassah will be metabolic syndrome and diseases associated with the Hepatitis B and C viruses.
Professor Yaron Ilan is with us today and will give you a more detailed report on the basis of the work and our current progress as we develop this technology towards human clinical trials. A well-received paper on one aspect of the technology, Fatty Liver Disease, was delivered at the prestigious American Liver Society Meeting last month. I congratulate the Hadassah team on this achievement. Many papers are proffered to this group and few are accepted for presentation.
Market reach of Travelan
Immuron is unusual for a biotech company in that it is generating revenues from the commercialisation of one of its early research and development projects, in the form of Travelan .
An export market has been developed by way of Alaven Pharmaceuticals in the USA. This company is in the process of manufacturing and starting distribution of Travelan within the USA. Further orders have been received from our distributors in South Africa, Pharmaco, when the product is sold in pharmacies and through Travel Medicine Clinics. In addition, Immuron is currently in final negotiations with a third party for the distribution of Travelan within Australia and New Zealand, and with a view for other overseas markets, so further enhancing market share and reach of the product. Dr Rawlin will provide more details on this transaction during his presentation.
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So for shareholders who have been strong supporters of this product in the past, the plan is that whilst the name ‘Travelan’ will not change, it will be sold under the name of the world’s 15[th] largest provider of over the counter products.
In preparation for the commercialisation of products into the Medical Foods category, particularly in the USA, Immuron convened an independent expert panel that reviewed the Company’s platform of hyper-immune colostrums. This expert panel agreed that hyperimmune colostrum met the definition of Generally Regarded as Safe (GRAS) under FDA regulations. This classification will be very important because it will greatly assist the future commercialisation of the products for HIV and mucositis, along with products which may be developed as a result of the Hadassah collaboration.
Research and development projects
Immuron is conducting phase 2 trials for the use of hyper-immune colostrum containing antibodies to lipopolysaccharide (LPS) as an adjunct in the treatment of people with AIDS.
Two scientific groups, one in Australia and the other in the USA, are working with populations of HIV positive people at different stages of their disease. Both groups are exploring if Immuron’s hyper-immune colostrum can decrease the troublesome over-activation of the gut immune response by decreasing the triggers (such as LPS) and can increase the healing capacity of the lining of the gut.
Immuron anticipates that the results of both trials will be received in the March 2010 quarter.
Immuron is also undertaking research into the use of antibodies given orally or by inhalation for the prevention and treatment of influenza. This work is being undertaken in conjunction with the University of Melbourne, and with the assistance of an Australian Research Council Linkage grant. Using laboratory animal models, good protection from infection for a period of up to seven days has been achieved. This is an exciting result, in particular in the current climate. We are following this line of development strongly to make the most of the findings and timing.
A phase 2 trial for the treatment of mucositis is underway at the Sourasky Medical Centre in Tel Aviv. This trial is using hyper-immune colostrum prepared by Immuron to control inflammatory responses in the gastro-intestinal tract following cancer treatment. Completion of this trial is expected in mid 2010, and is being undertaken with the assistance of a grant received by Immuron under the Victorian Government’s Vistec scheme.
A phase 2 trial for treatment of Ulcerative Colitis (IBD) is underway at Sourasky Hospital in Tel Aviv. It has only two more volunteers to recruit so it is on track for full results to be available Q2 2010.
Change of name and location
To symbolise the change in direction of the Company you will have noticed a name-change to better reflect the company’s expansion into a wider Oral Immunotherapy portfolio. The Company is situated in North Melbourne near Melbourne University to allow easier
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interaction with key scientists and board members as the current and new directions are developed.
In conclusion, the coming year should be an exciting period in terms of our research and commercialisation potential as the current clinical trials are completed, and we undertake the proposed clinical trials in respect of the Hadasit oral immunotherapy technology.
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Colin Chapman Chairman.
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ASX:IMC; OTCQX: IMROY
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Annual General Meeting
www.immuron.com 23rd November , 2009
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Forward Looking Statements
This presentation contains forward-looking statements which are subject to risks and uncertainties. These statements include those regarding the therapeutic and commercial potential of Immuron technologies and products in development and commercialization. Any statement describing the company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an “at-risk statement”. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements to be different from the statements in this presentation.
Actual results could differ materially depending on a number of factors including, but are not limited to, results of studies and trials, the timing and effects of regulatory actions, ability to penetrate markets, the strength of competition and the effectiveness of patent protection.
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Confidential
Dr Grant Rawlin, CEO Immuron
A new hands-on CEO based in Australia: to bring on the new direction of Immuron.
Developed the harvesting system and regulatory stance that is core to our company – i.e. the core platform from lab to market.
Developed the patent portfolio.
Widened the reach of the core technology. Developed close ties with Hadassah for over a year.
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2010 – A pivotal year: what to expect
More deals to commercialise current products with third parties in both food and pharma spheres
Look for news of a series of completed licensing deals starting now and onwards particularly over Q1 and Q2 of 2010 in both ‘Pharma’ and ‘Functional Food’ spheres.
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Travelan :
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South Africa and USA distribution in place and developing.
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- News Now : Terms now agreed for distribution Australia / New Zealand to expand local sales. Investigating further markets with in Asian region in particular.
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Confidential
The Nycomed license
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Nycomed : term sheet is now agreed to license Travelan and Travelan product extensions for sale in Australia/New Zealand.
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To be sold as under ‘Travelan’ trademark under Nycomed label and supported by the Nycomed sales force.
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First Nycomed packaged Travelan product to be produced in Q1, 2010.
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Nycomed will provide significant market support for the product.
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Who is Nycomed ?
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Privately owned Global Pharmaceutical company
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One of the top 25 pharmaceutical companies, 15[th] largest global OTC company,
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Nycomed Global is based in Switzerland (Pharma €3.4 billion sales, 12,000 employees).
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Nycomed, Australia is based in Sydney ($110 million sales, 120 employees) focus on OTC market
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Nycomed corporate strategy fits with Immuron’s: “Pioneering partnerships” for licensing in new products and with working with innovative companies for joint product development.
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Major areas of interest in common with Immuron: Gastrointestinal medicine and respiratory medicine.
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Confidential
2010 – A pivotal year: what to expect
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Complete the current Phase 2 clinical trials
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HIV adjunct therapy (Australia),
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HIV adjunct therapy – Cleveland Clinic (USA)
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Inflammatory Bowel Disease (Tel Aviv)
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Mucositis prevention (Tel Aviv)
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Look for news of results, analysis and decisions on further actions for all above in Q2/3 2010.
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If successful what then? e.g. HIV: License to HIV company or OTC company and use swift regulatory stance of GRAS to enter market quickly. Income from both license and production of raw material.
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The ‘new’ program - Influenza A
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Influenza antibody program shows very successful treatment and prevention in animals with intra-nasal formulation.
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Next steps: investigate an oral formulation in animals. (ARC Linkage Grant won).
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Look for publication of current results Q1 2010.
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To make the most of this concept we should partner and co-develop with the future marketers. Discussions are advancing around the concept as an OTC product.
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Confidential
So what’s new? The next 18 months.
Building the new technologies
Building on the new alliance Immuron/Hadassah: “Ilan and Rawlin”
Building on what?
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Immunotherapy technology (Yaron)
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R and D in 2 countries plus a responsive clinical trials unit – what an advantage!
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Hadasit contacts and reach – what an advantage!
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Hadassah WHO Centre of Excellence is helping with Influenza and expanding the influenza concept in light of preliminary good results – an unexpected advantage!
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The overall strategy of the alliance
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Fast turnover of oral immunotherapy developments into human pilot trials at Hadassah clinical trial unit.
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Human results have much greater value for negotiation.
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Hadasit to find best commercialisation partners
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Realise short-term value through co-development partnerships/licensing of human proven concepts.
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Realise long-term value through product royalties and sale of raw product to distribution partner.
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Confidential