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Symbollon Pharmaceuticals Inc. (SYMBA) |
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CEOCFO
Interview Index |
This is a printer friendly page! With
no safe and effective products on the market for treating fibrocystic
breast disease Symbollon Pharmaceuticals is taking the lead as it enters the final stages
of testing for its IoGen™ drug BIO: CEOCFOinterviews: Mr. Desjourdy, you have been with Symbollon for quite a while; what attracted you initially and how has that played out for you over the years? Mr. Desjourdy: “What first brought me to Symbollon was an opportunity to work a small growth company. I spent almost ten years on the service side working as a CPA and a lawyer and I wanted to get into a company that had a lot of growth potential and that offered me an opportunity to work in several different areas and Symbollon has certainly provided all of that.” CEOCFOinterviews: What is the basic idea behind Symbollon? Mr. Desjourdy: “Symbollon is premised on a core technology based the active molecular iodine. We have the unique ability to produce formulas that generate high levels of molecular iodine. We have been granted eighteen U.S. patents, which cover different formulas producing molecular iodine. The technology has application in two distinct areas; one is the antimicrobial marketplace, which includes indications such as topical dermatology, wound care, oral care and infection control, and the other is as a therapeutic for women. In that area, we have developed a tablet, which is taken once a day by a woman and can resolve certain conditions that are related to hormonal imbalances within a woman.” CEOCFOinterviews: Why are you the only company in the world working in this area? Mr. Desjourdy: “I hope it is because we are the only company that has the ability to do it. Iodine has been around for a long time and it is not cutting-edge in the sense of where science is spending its money these days. Symbollon is unique in the sense that we were the first people to discover a way to generate high levels of molecular iodine. We have just built on those early inventions and have put together a core technology, which has eighteen patents issued. At this juncture, it would be difficult for someone else to come in and replicate the work we have done.” CEOCFOinterviews: What is molecular iodine? Mr. Desjourdy: “Molecular iodine is the active species of iodine. Iodine is actually comprised of several sub species, including iodide, iodate, tri-iodide and molecular iodine. When you look at a pharmaceutical formulation, the ideal formulation would delivery 100% molecular iodine without other types of iodine species present. This is because molecular iodine is the active species that kills the germs in the antimicrobial applications, and it is the least toxic and most effective in terms of treating women. Our formulation have 100% molecular iodine, and because of that, we would be able to use far less iodine and still be far more efficacious. For example, our high level disinfectant is a clear liquid that you would be able to safely ingest.” CEOCFOinterviews: How have you progressed with the various products you are developing? Mr. Desjourdy: “We have produced one product in the antimicrobial marketplace. We launched that product in 1995. It is a bovine teat sanitizer, IodoZymeŽ, which is sold in the U.S. and the U.K. by our marketing partner West Agro, Inc. We have other formulations in the antimicrobial application area ready for clinical development. Our current clinical efforts have been focused in the women’s healthcare area. We have a compound called we refer to as IoGen™, which is a tablet taken once a day by women. The first indication for IoGen™ is the treatment of fibrocystic breast disease (FBD). We are presently preparing to enter into our Phase III pivotal trials for IoGen™ this spring.” CEOCFOinterviews: What led you into the women’s health area? Mr. Desjourdy: “Initially, Symbollon focused on the antimicrobial uses for the technology. A few years ago we became aware of the potential use of the technology in women’s healthcare.” CEOCFOinterviews: You are starting the Phase III clinical trials; where are you in the process? Mr. Desjourdy: “The goal is to get IoGen™ to the market. The remaining tasks to be completed include conducting two pivotal trials and one two-year toxicity study in rats. We intend to launch the first pivotal trial and initiate the two-year rat study this summer. In about twelve months when the first pivotal trial is completed, we will initiate the second pivotal trial. We intend to file for marketing approval in late 2006.” CEOCFOinterviews: Do you have cash to get this operating? Mr. Desjourdy: “We have sufficient cash to operate the company into early 2005. We are out looking for additional resources so that we can undertake the task that I have just outlined.” CEOCFOinterviews: Is there also a connection to preventing breast cancer? Mr. Desjourdy: “The initial indication for IoGen is fibrocystic breast disease. Fibrocystic breast disease is a benign condition where excess cell growth, otherwise known as fibrosis, in a woman’s breast can lead to pain and tenderness. Our indication will be for the treatment of moderate to severe cyclic mastalgia (breast pain and tenderness) associated with fibrocystic breast disease. The drug works by reducing and eliminating the fibrosis and therefore eliminating the pain and tenderness. The possible connection to breast cancer is based on the IoGen’s mechanism of action. We believe that mammary cells have the ability to absorb iodine. Once the iodine is absorbed into the cell it combines with peroxidase. The byproduct of that reaction is an antiproliferative iodinated lipid. We believe that agent is resolving and eliminating the fibrosis. If that mechanism of action is accurate, then that agent should also be able to prevent the formation of malignant tumors this population of fibrocystic breast disease patients who might otherwise be at an increased risk of breast cancer.” CEOCFOinterviews: How widespread is the fibrocystic breast disease? Mr. Desjourdy: “The scientific literature indicates that approximately 30-50% of the childbearing-age women have some degree of benign fibrosis in their breasts. That represents about 20-33 million women in the United States. Market research also indicates that about 11-20% of that same population has clinical cyclic mastalgia (breast pain). That represents about 7-13 million women in the United States.” CEOCFOinterviews: Is there much interest in solving this problem? Mr. Desjourdy: “This is not an indication that has received significant interest to date from the pharmaceutical industry. There are other companies that are initiating programs for compounds to treat fibrocystic breast disease; however, Symbollon is certainly in the lead and has been out in the forefront in developing IoGen™. Fibrocystic breast disease certainly represents an unmet market need, and I believe that when the proper pharmaceutical is delivered to the marketplace, people will begin to realize how many women are in need of treatment.” CEOCFOinterviews: Do you have any indications beyond the area of fibrocystic breast disease? Mr. Desjourdy: “We believe that IoGen has additional indications in women’s healthcare beyond fibrocystic breast disease. Once IoGen™ is on the market for fibrocystic breast disease, we would envision doing supplemental work to broaden its indications. The other indications in women’s healthcare include endometriosis, ovarian cysts, and premenopausal breast cancer. Beyond women’s healthcare, Symbollon’s technology has a wide range of potential uses in area of antimicrobial applications. We have in the lab now formulations for an antimicrobial hand wash and hand cream. The molecular iodine hand washes and hand creams are a perfect solution in terms of killing pathogens because molecular iodine has the ability to penetrate into people’s skin and efficaciously outgas over time. So not only would you be able to kill the germs upon application, but over time as a person comes into contact with other pathogens the formulation would continue to have killing power. We also want to explore possible uses in topical dermatology. For example, we have a formulation ready to enter clinical trials to evaluate the technology as a treatment for acne.” CEOCFOinterviews: You are acquiring some data from Mimetix Inc. Will you tell us more about that? Mr. Desjourdy: “Mimetix is a company that was working with the same active molecular iodine that is generated by IoGen. They were the first company trying to treat fibrocystic breast disease with molecular iodine. They got to the point where they ran out of money and were not able to continue their development effort. We are purchasing from them their patient data records and intellectual property. Their patient data records contain information on over 800 patients who were dosed with molecular iodine at or above the dosage we will be taking into our pivotal trials. We intend to supplement our information to FDA (Food and Drug Administration) with those patient data records.” CEOCFOinterviews: Do you have income from any antimicrobial products? Mr. Desjourdy: “IodoZymeŽ, our bovine teat sanitizer generates somewhere between a quarter of a million and half million annually in revenues.” CEOCFOinterviews: What is the business of the company on a day-to-day basis? Mr. Desjourdy: “We operate as a virtual corporation in the sense that there are only two employees. Dr. Jack Kessler handles drug development and clinical trial activities. I focus on the business side of the operations. My activities include investor relations, business development, manufacturing, financing, etc. We try to focus our daily activities to advancing various product opportunities based on our technology and ultimately forming marketing relationships to commercialize those opportunities.” CEOCFOinterviews: In closing, why should potential investors be interested and what should they realize that perhaps that don’t see when they first look at the company? Mr. Desjourdy: “Symbollon has a low market cap relative to the fact that we are about to enter into the final stages of testing for our drug IoGen™. If you look at the fibrocystic breast disease market, it is a potential very large market opportunity. There are currently no safe and effective products for its treatment. If Symbollon is able to deliver IoGen to the market, we should have control of the market for quite some time to come. If you are evaluating the probability of IoGen making it to the market, you need to consider that before Symbollon got started the IoGen program, other parties reported successfully treating over 1,500 women with fibrocystic breast disease with iodine. We now know that from the literature and our own work that molecular iodine does work and is safe for women to take. We are ready to complete the remaining requirements that the FDA has indicated are necessary for IoGen to be get to market. If I look at that large market opportunity and the known efficacy and toxicity profile for the drug, I think that our market cap is not reflective of where we are in this clinical development program.” disclaimers |
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