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Chairman's address to the Annual Stockholders' Meeting
Marshall Edwards Inc 2007 Stockholders Meeting
Ladies and Gentlemen,
Welcome to the Marshall Edwards, Inc., Annual Stockholders Meeting. I am Bryan Williams, the Chairman of the Company.
Before we move to the formal motions to be put to the meeting, I would like to make some comments on the current state of the Company, highlight some of our advances and reinforce our strategy for commercialization.
After the formal part of the meeting, our CEO Christopher Naughton, will address further matters of strategy and management, and our Group Director of Research, Professor Alan Husband, will update us on the status of the Ovature trial and the clinical and preclinical programs which we are conducting.
Marshall Edwards, Inc., is in business to in-license clinical stage oncology drugs primarily from our majority shareholder Novogen Limited; to bring them through the clinical stages of development; and complete the preclinical evidence and manufacturing methodologies necessary for product registration. We will then out-license the drugs to biopharmaceutical companies.
Our current year has been focused on this program and advances have been evident and positive across each development aspect of this operational plan.
Firstly we have broadened our drug portfolio by further developing triphendiol, formerly known as NV-196. Triphendiol already has a volume of pre-clinical evidence compiled and encouraging phase I data. Although we already have human data on safety, our task this year has been to amass information for the submission to the FDA of an IND to enable clinical trials to be conducted in the US. This involves pre-clinical and manufacturing data to be produced and assembled and we are in a good position for this application to be lodged in the first half of 2008. We are working closely with our Washington DC based regulatory lawyers to capitalize on all FDA sanctioned avenues available for fast assessment of this drug which is targeted for pancreatic and bile duct cancers. We are very positive about the potential for triphendiol.
The extension of our portfolio via in-license is most likely to come again from our very advantageous relationship with Novogen. As you will be aware, we have a preferential licensing arrangement with Novogen which allows us the first right to bid and the last right to match any oncology drug from its research, other than topical products, which have progressed into the clinic. Novogens next candidate compound which we are monitoring very closely is NV-128. Professor Gil Mor of the Yale University School of Medicine presented some very exciting mode of action findings about NV-128 in October here in San Francisco at the AACR Molecular Targets and Cancer Therapeutics Conference. The take away message for us is that not only does NV-128 operate via a novel pathway, it may very well be synergistic with our drug phenoxodiol. We will continue to monitor this development and know that our special relationship with Novogen will facilitate our access to this exciting candidate drug NV-128.
In addition to the advances in the pre-clinical and clinical drugs mentioned so far, the primary focus this year has been on the phase III human trial of phenoxodiol in ovarian cancer. This is the Ovature study that has the potential to first crystallize our commercialization program.
Ovature is the international double blind controlled trial that has been the recipient of a Special Protocol Assessment by the FDA. Whilst no guarantees can be assumed, this process ensures coordination between the Company and the FDA on the process, expected outcomes and regulatory conditions under which the trial could be deemed a success and thus the timing and conditions for an application for marketing approval.
Details of the protocol and progress of Ovature will be in Professor Husbands address at the conclusion of this meeting, and he will also detail the recent clinical extension of phenoxodiol into the phase II early stage prostate cancer trial being conducted at the Yale University School of Medicine. With its safety profile and expanding therapeutic applications, the future of phenoxodiol looks very positive.
The oversight of these programs and the strategic development of the Company is ultimately the Boards responsibility. I have been your Chairman now for over twelve months and I am pleased to report that the Boards competence and enthusiasm is a great asset of the Company. My experience at the Cleveland Clinic in Ohio, where I had a long involvement in oncology research and management of preclinical developments, enabled me to assess the potential of competing drug candidates. I believe that our portfolio here at Marshall Edwards equals or exceeds any intellectual property package of potential oncology candidates that I saw in many years at that very successful organization.
In addition to the scientific and clinical backgrounds of myself and Professor Nestel and the pharmaceutical industry experience of Mr. Johnston and Mr. Naughton, the financial strength of Mr. Breckenridge has been augmented this year by the US financial markets experience of our US based director Mr. Rueckert. I formally introduce Bill Rueckert to the shareholders and welcome him to the Board.
Your Board has been very conscious of the performance of the share price this year. It is evident to us that the current market for biotechnology has not been favorable and our Company in particular has had a languishing share price. We do not believe that the price represents the true value of the Company and the advances that have been made in the last year, an opinion shared by some analysts. Mr. Naughton will recount some of the investor relations initiatives that we have undertaken to address this issue. We are conscious of shareholder concern in regard to the share price, and although we concentrate on the operations of the Company and not the vagaries of the share market, we nevertheless do take counsel on the share price impact of all of our initiatives.
In anticipation of the pending commercialization program we have continued our close relationship with bankers JPMorgan in New York. Its ongoing assessment of the appropriate timing for licensing and M&A opportunities is monitored by the Board and we believe that the Company is well set for a defining event at or around a potential interim analysis of the phenoxodiol Ovature trial.
2007 has been a good year for the consolidation of the Companys programs, of advancements into the clinic, of manufacturing validations, and regulatory preparedness. Provided patient recruitment during 2008 is on target, we expect to have considerable data to share with the regulators, the industry and shareholders when we meet again.
Bryan Williams Chairman
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