Access’ President and CEO, Jeffrey B. Davis recently conducted a Q&A with OutsideIn Research, a small-cap equity research firm. The interview was published in two parts, the first of which is below:

Q: Tell us about Access Pharmaceuticals, its history and its focus.

Jeffrey B. Davis: Access Pharma is a Dallas-based biotechnology company that’s been around for many years, but underwent a re-engineering and re-focusing roughly three years ago. At that time, the Company refocused on its oncology assets, and divested of its dermatology and wound healing assets. The three year “re-engineering” effort has been a great success, resulting in its first FDA-approved therapy, MuGard, significant development in its two Phase 2 assets, ProLindac and Thiarabine, and great progress in its Cobalamin Oral Drug Delivery and Targeted Drug Delivery platforms. Over that period, the Board of Directors was revamped, new management expertise brought in, a new strategy put in place, and many partnerships being signed. I believe that it positions Access Pharmaceuticals very well for success, and I think it’s a great time for the investment community to take a fresh look at our Company.

Q: What are the key components of the strategy which differentiates Access from other biotechnology companies?

Jeffrey B. Davis: First and foremost, we at Access focused on late stage assets for the pipeline, and we have that in MuGard, which is FDA-approved and launching commercially in the US, Europe and the Far East.  Not many small biotechs can actually get a product through development, and through the FDA to approval;  Access has done it, and we’re proud of it.  Our next two drug candidates, ProLindac and Thiarabine, have already been through multiple Phase 2 human trials, so we know they’re active in humans and we have a good idea of their safety profile;  many biotechs are at the preclinical or Phase 1 stage (before human activity/efficacy), where the risk profile is significantly greater.  So, having late stage assets is key.

Second, we’ve been active in our corporate partnering activity.  This helps keep our cash burn in check, and allows us to gain clinical development and marketing experience through those collaborations.  Partnering is key to validation of your programs as well.

Lastly, we think its key to have the right board of directors and management team in place, and to really focus on building shareholder value.  Those have been key to our success to date.

Q: Please update clients and potential users on MuGard Commercialization Activity. What is MuGard?  What condition does it treat, and why is it important to the oncology community?

Jeffrey B. Davis: MuGard is Access Pharma’s FDA-approved treatment for oral mucositis (“OM”), a debilitating side effect of chemotherapy and radiation therapy.  MuGard is patented, and it’s FDA approved here in the US, has gained EMEA approval in Europe, and is approved in Korea as well.

Oral mucositis is an ulceration of the oral mucosa, or the skin in your mouth, tongue and down your esophagus (see photos below).  Its very common, in so much as roughly 90% of radiation patients, and 40% of chemo patients will experience some form of it.  But patients are usually not made aware of it prior to treatment, because there hasn’t been anything with clinical evidence that it can be prevented or treated, until MuGard.

And, OM is very problematic and costly, as patients have a lot of pain which require pain killers, have significant problems with eating and drinking which leads to the requirement of a feeding tube and/or hospitalization, and it can lead to infections which require antibiotics.  Most importantly, it very often leads to a reduction or stoppage in the underlying cancer treatment – which can lead to sub-optimal clinical outcomes that are not good for patients or clinicians.  Until now, the treatments have been palliative in nature, and are often utilized only after the patients have presented with oral mucositis.  MuGard has been FDA-approved for the management of oral mucositis, and we have and will continue to present clinical experience data and information that reflects its utility in the potential prevention and ultimate treatment of patients with oral mucositis.

Q: How big a problem is it here in the US?

Jeffrey B. Davis: The NCI and NIH websites and statistics state that they estimate there are 400,000 patients in the US that get a formal diagnosis of oral mucositis.  However, that’s just part of the potential patient population, as they go on to state that they believe that roughly half of the patients never get a formal diagnosis of oral mucositis.  We believe that this occurs because there’s never been anything to give to patients to prevent OM, and after they present with OM, clinicians usually just go to some sort of pain relief.  So, the market is potentially up to one million patients annually in the US, and therefore the market opportunity can be measured in the multiples of hundreds of million dollars in the US alone.  Europe and the Far East are probably each equally as large.  It is really what they call an “unmet clinical need” and we at Access are very excited about the opportunity to bring MuGard to the oncology community to address this problem.

Q: Where are Access and its partners in the commercialization of MuGard?

Jeffrey B. Davis: Access recently announced it had signed two specialty distribution agreements here in the US, one with BioScrip and one with iMedicor/DMS.  The official commercial launch is occurring very soon, and Access and its partners are already in the field working with large oncology networks and key clinical sites to educated oncologists and radiation oncologists, and to provide MuGard sampling kits and materials.  The initial feedback from clinicians and patients has been very positive, and we expect to continue to have announcements on the progress and feedback throughout the remainder of the year.

We’re excited to say that MuGard has launched in Europe through our EU partner SpePharm, and will launch in the Far East through our Korean marketing partner later in the year.  Initial feedback from our partners about their experience has been very positive as well.  In Europe, they are commercially launched in roughly 6 countries, and will roll-up in the remaining 20-odd EU countries throughout the next 12 to 18 months.  Additional announcement regarding their clinical experience will be forthcoming as well.

Q:Can you provide any detail on the Clinical Experience thus far?

Jeffrey B. Davis: MuGard has been used in more than 2,000 cancer patients globally, and the clinical experience has been very positive; therefore we at Access are pretty excited about the upcoming full commercial US launch of MuGard.  The data and other clinical information will reflect that it is very supportive of the FDA-approved label claims and directions for patient use from a number of perspectives.  First, the data from the US trial support the instructions that state patients should use it prior to starting their underlying therapy – and in the trial, 43% of a head-and-neck cancer patients using MuGard didn’t get OM (and OMAS score <0.5), whereas normally virtually 100% normally do.  Also, those patients using it in a preventative setting had reduced levels of erythema, which is a “precursor” inflammatory condition that occurs prior to the actual OM ulcerations.  So, we are positioning MuGard to be used prophylactically, or in a preventative sense.  In Europe, the regulatory label is for both prevention and treatment or oral mucositis, and the clinical experience supports the label.  Additionally, they are finding that a significant number of patients – both radiation and/or chemotherapy patients – actually wait until they present with oral mucositis lesions (rather than use it preventatively).  These patients have experienced a significant reduction in their pain or oral discomfort while using MuGard, which is really a critical clinical benefit.  Clearly, it’s the oral pain or discomfort that causes patients to stop eating, drinking or even discontinuing their underlying cancer treatment.  Given there is no pain drug in MuGard, we believe the reduction in pain and oral discomfort is correlated to an improvement in the underlying OM;  both of which are beneficial to the patient.  So, there is a lot of clinical experience and data on MuGard, and there is much to be excited about whether you’re looking at prevention of OM, curative use of OM including reductions in pain and oral discomfort, and lowered erythema scores in patients with various oral inflammatory conditions, such as xerostomia and stomatitis.

Q: Any other observations from the MuGard clinical experience?

Jeffrey B. Davis: We at Access think its important for clinicians and patients to think about OM the same way they think about nausea and vomiting – meaning, in a preventative way. Even before your first course of cancer treatment, its highly likely that your oncologist or radiation oncologist will have written you a prescription for an anti-emesis drug in anticipation of you experiencing nausea and vomiting. This was an education process 10 years ago which anti-nausea drugs were just launching; today, it’s simply part of the treatment protocol. Despite the prevention label in Europe, many patients don’t start using MuGard until after the OM lesions or ulcers occur. We believe the best course of treatment is to use it prophylactically, and we are encouraging clinicians and patients to use MuGard “early and often” as we believe that it will lead to the best outcomes. MuGard, unlike some competing products, comes in a ready-to-use formulation which is much easier for patients to use, and supports patient compliance. And the treatment is generally well accepted and no treatment related adverse reactions have been reported.

Click here to read Part 2 of the interview. Topics discussed: Cobalamin, ProLindac and Thiarabine.

This interview contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.