TWST: Would you begin with a brief overview of Access Pharmaceuticals, Inc. (AMEX:AKC)?
Mr. Gray: We refer to Access Pharmaceuticals as an emerging specialty pharmaceutical company, executing a reduced-risk product development and commercialization strategy. What we have done is assemble a broad technology base from which we are developing product candidates. Our primary customer is the mid to large pharmaceutical companies, where it is our objective to provide value-added products to these customers for ultimate marketing to the end user. At this point in time, it is not in our business strategy to have our own sales and marketing organization. We are more of a development company, as compared to a fully integrated company or a research company.
TWST: When you say you’re an emerging company, do you mean that literally?
Mr. Gray: Right now, we have one product that was developed by the company that has been approved by the FDA, and we’re anticipating that it will be approved throughout Europe in the upcoming six to nine months. We have numerous products in advanced clinical testing, so, from a product offering point of view, we consider ourselves an emerging pharmaceutical company.
TWST: Where would you like to take Access Pharmaceuticals over the next two or three years?
Mr. Gray: Well, over the next two or three years, we would like to have numerous products from our development portfolio move through the registration process. Right now, we have a product line extension to our currently approved product that is in Phase III development. That product is an oral disc formulation of amlexanox, for the prevention and treatment of canker sores, which could have a registration dossier filed within 12 months. We have a product that is currently in Phase III development in Europe, which is a delivery form of clindamycin for the treatment of acne. We’re anticipating that a registration dossier will be filed in the UK during the fourth quarter of this year. We also have amlexanox in an oral rinse form for the prevention and treatment of mucositis, which is currently in a Phase II study, and we anticipate that this will move to Phase III in the next 12 months. The data generated from the current study will determine our ultimate development strategy. Assuming that the data are very positive, we would see that this would give us the potential for very rapid development and filing with the FDA and international regulatory agencies within two years. So over the next two to three years we have the possibility of having numerous products enter the regulatory process throughout the world. Importantly, during this period I believe the company will commence generating positive cash flow.
TWST: How would an acne product such as clindamycin be administered?
Mr. Gray: This would be a topically applied product. We have a technology for the delivery of drugs topically that uses zinc to reservoir the drug in the skin, as compared to other systems that are developed to deliver drug through the skin, such as transdermal drug delivery systems. This is a system for reservoiring the drug in the skin to act locally in the skin. |
