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Opthea Ltd — AGM Information 2011
Nov 23, 2011
32698_rns_2011-11-23_d2001214-33e9-41d9-acbd-d6c84812f88f.pdf
AGM Information
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ASX / Media Release
24 November 2011
CHAIRMAN’S ADDRESS TO ANNUAL GENERAL MEETING 24 NOVEMBER 2011
Ladies and Gentlemen, welcome to the 27th Annual General Meeting of the members of Circadian Technologies Limited.
May I introduce the Directors of the Company who are present here today:
Mr Don Clarke Ms Tina McMeckan Dr Errol Malta Mr Robert Klupacs, Managing Director
Dr Jonathan Skipper, who resides in the United States, is not able attend the meeting today and has provided his apologies. As shareholders are aware Dr Skipper retires from our Board effective as from today, and I would like to take the opportunity to thank him for the enormous contributions he has made over the past 3 years.
I also introduce the company’s auditor Ms Joanne Lonergan of Ernst & Young, Mr James Hutton from Minter Ellison Lawyers, Gary McLean from Deloitte, our nominated auditor, and our company secretary Ms Susan Madden.
A quorum being present, I now declare the meeting open.
Let me start by saying that we are very excited by the future of your company building on what we believe to be very significant achievements this year, culminating in the recent clearance by the FDA of our IND for VGX-100, as well as the new opportunities which have arisen to develop our technology for unmet clinical needs in ophthalmology, and in clinical diagnostics.
As shareholders are aware, Circadian’s strategy is based on the significant commercial potential of its subsidiary Vegenics’ technologies. Vegenics owns worldwide intellectual property rights to three targets for the treatment of cancer, Vascular Endothelial Growth Factors (VEGF) C, D and the VEGFR-3 receptor. The cancer treatments we are developing are predominantly antibody-based drugs.
While Circadian is focusing primarily upon cancer, VEGF technology also has applications in other diseases. Shutting down angiogenesis and/or lymphatic vessel growth is important in eye diseases, particularly diseases or injuries of the cornea. Circadian has licensed some of its IP to other companies for exploration of these therapeutic opportunities.
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During the 2011 financial year, we made significant progress in the execution of our business strategy.
The key components of this strategy are:
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Advancing our drug-development pipeline to show significant clinical efficacy in appropriately designed human clinical trials;
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Continuing the extension and enforcement of our core intellectual property position covering VEGF technology to both protect our ongoing development activity as well as generate increasing revenues through licensing partnerships; and
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Continuing to build partnerships for the commercialisation and ongoing development of our therapeutic and diagnostic products.
The following is a brief summary of our activities in each of these areas:
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In June this year we announced the completion of a significant array of pre-clinical studies with VGX-100. In particular, we successfully completed GLP toxicology studies in two animal species in accordance with FDA guidelines. We also announced that we intended to commence clinical trials with VGX-100 in cancer patients before the end of 2011 under and IND filed with the FDA. As I mentioned earlier the FDA cleared this IND at the end of October and we now expect to dose our first patient before the end of the year.
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In June, 2011, based on some very exciting data generated by our collaborators at Harvard University and the pre-clinical development work we had completed with VGX-100, we announced that we would also be developing VGX-100 as a therapeutic agent to treat front-of-the eye (corneal) diseases. We are currently undertaking intensive pre-clinical studies and are targeting commencement of clinical trials in these indications in the second half of 2012.
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In September 2010, we were granted a patent in the US claiming diagnostic kits for detection of VEGF-D in human samples such as blood. This patent is important in protecting the VEGF-D test launched in partnership with Cincinnati Children’s Medical Hospital to diagnose the debilitating lung disease – lymphangioleiomyomatosis or LAM for short.
Another significant achievement for us was the granting of an exclusive, global licence by Chugai Pharmaceutical Co, Ltd to Chugai IP relating to VEGF-D. The licence secures Circadian’s position as the dominant player in respect of VEGF-D worldwide.
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Since the announcement of our strategic partnership with Healthscope in February 2009, to commercialise a diagnostic for Cancers of Unknown Primaries (CUP), Healthscope, in collaboration with Circadian, Peter MacCallum Cancer Centre and NICTA, has continued to invest considerable time and effort into the development of this product. Although the status of development continues to remain commercial in confidence, beta testing of the diagnostic is expected to be completed in early 2012.
- Another of our partners, ImClone Systems - an Eli Lily company, commenced Phase I clinical trials in cancer patients in the United States which are expected to be
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completed in the second half of 2012. ImClone has exclusive rights from our subsidiary company, Vegenics, to develop the VEGFR-3 antibody in return for annual licence fees and royalties on potential future product sales.
- As we focus our efforts on our research and development, we have continued to reduce our administrative costs through the streamlining of our financial and administrative systems and reduction in the size of the board from 6 non-executive directors to 4. We are currently in the process of reviewing and restructuring the remuneration of our senior executives to enable us to remain cost effective and competitive as well as continue to retain a high calibre team.
We are grateful for the support of shareholders as we continue the transformation of Circadian from a biotech incubator to a leading drug development company. The Board shares the frustrations of shareholders that the continued implementation of our business plan and development activities is yet to be valued in our share price. While we believe Circadian is enormously undervalued based on a comparison with its Australian and international peers, we are confident that as we move into the clinical development phase during 2011/12 and obtain increasing royalties from our partnered products that the true market value will begin to emerge.
Robert Klupacs will provide more details on Circadian’s achievements during the 2011 financial year later this morning. He will also provide an update on activities since year end.
With a continuing and enhanced focus on drug development, a strong board of directors, an outstanding management and advisory team and strong financial position, we look forward to consolidating the successes of the past year and building further value for shareholders in the future.
Yours faithfully
Dominique Fisher Chairman
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