Q&A with Jeff Davis of Access Pharma (OTCBB: ACCP)
Friday, August 20, 2010 at 5:51AM 
Jeffrey Davis is the CEO of Access Pharmaceuticals (OTCBB: ACCP) which is an emerging oncology-focused specialty pharmaceuticals company (January 2008 to present). He is also a Partner in two equity fund groups, SCO Capital Partners LLC and Lake End Capital LLC. The OutsideIn Research interview is broken into two sections:
- Part I - covers Access Pharma's strategy and its first product MuGard, which is in product launch now, and
- Part II - covers Access Pharma's three products in the pipeline, Cobalamin, ProLindac, and Thiarabine.
Jeff Davis
PART I - ACCP Strategy and MuGard Product Launch
OutsideIn Research - Tell us about Access Pharmaceuticals, its history and its focus.
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.
OIR - What are the key components of the strategy which differentiates Access from other biotechnology companies?
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.
OIR - 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?
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.
OIR - How big a problem is it here in the US?
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.
OIR - Where are Access and its partners in the commercialization of MuGard?
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.
OIR - Can you provide any detail on the Clinical Experience thus far?
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.
OIR - Any other observations from the MuGard clinical experience?
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.
Access Pharmaceuticals (OTCBB: ACCP) has made a move up since Part I of our interview which covered MuGard, ACCP's product in production. Part II - covers Access Pharma's three products in the pipeline, Cobalamin, ProLindac, and Thiarabine.
Cobalamin Oral Drug Delivery / Targeted Drug Delivery Technology
OIR - Can you help explain to the readers your Cobalamin platform technology, in simple layman’s terms?
Sure, I can certainly try. It’s easiest to explain in the context of the Oral Drug Delivery activity ongoing, so I’ll use that first to explain how the technology works.
First, you should know that drugs have to be injected today because the molecule itself is too large, or simply physically too big to get across the digestive tract. Because they can’t get across your digestive tract, some drugs need to be injected directly into your blood stream. Clearly, a technology that could transform “injectable” drugs into “oral” or pill forms of drugs would be very helpful to the pharmaceutical industry, and very valuable.
We, as humans, have mechanism to do this for Cobalamin, or Vitamin B-12, which is too big to go directly across the digestive tract. So we have a mechanism that occurs naturally in our stomachs and small intestines … and simply put, Access is using that same naturally occurring human mechanism for absorbing Vitamin B-12, to “trick” the body to absorb other large molecules, namely drugs, through the gut. So very simply put, we can take a large injectable drug – like insulin or human growth hormone, which people are aware need to be injected – and make them “look” like Vitamin B-12 to the human body, and get them to be absorbed in an oral form. We say it’s a “Trojan Horse” like mechanism of tricking the body into absorbing it orally, because we make it look like a vitamin. We have proven that this mechanism works in standard animal models, and that data has been confirmed by our collaborators. We have announced that Access has achieved unprecedented levels of “oral bioavailability” of insulin, greater than 80%, which we believe can make a pill form of insulin a commercial reality.
OIR - Where are you in the development?
Over the past 18 months or so, Access has signed four collaborative agreements around our Cobalamin oral drug delivery technology. Much progress has been made with an oral version of insulin, and an oral version of human growth hormone. Access recently announced an agreement to make an oral formulation of a large drug on the market, which sells close to $1 billion annually in the injectable form, and could be large in an oral form. We are actively seeking additional partnerships and collaborations, and hope to have additional announcements on the technology and potential agreements in the near future. Additionally, we recently announced an initiative with a clinical research organization called BioRASI, based here in the US, that is working with us to get the first human Phase 1 trial of our Cobalamin Oral Insulin drug candidate initiated overseas. More on that initiative is forthcoming as well.
What are the other applications of the Cobalamin technology?
The Cobalamin technology can also be used to make current drugs more targeted in their application. My drugs fail or aren’t as effective as they could be, because they don’t reach the targeted disease cell or don’t get incorporated into the cell to do their work as effectively as possible. Many diseased cells are voracious consumers of vitamins and nutrients, including Vitamin B-12. So, by making our nanoparticle versions of the active drug, and coating it with Vitamin B-12, Access can potential enhance the absorption or availability of the drug within the diseased cell. One example of this is the current delivery challenges around RNA interference drug candidates, or sRNAi therapeutics. Many scientists think that sRNAi drugs are the wave of the future, but the “delivery mechanism” for this type of sRNAi drugs has been the big challenge. Access is currently working on using its Cobalamin technology to make these sRNAi therapeutics “look” like Vitamin B-12 to the cells, enhancing delivery of these types of drugs into the diseased cell.
ProLindac Program
OIR - What is ProLindac?
ProLindac is Access’ proprietary platinum-based chemotherapy, which is currently initiating its first Phase 2 combination trial in Europe. This trial follows two previously run human trials that showed very good activity, and a very good safety profile. The new trial will be in women with recurrent ovarian cancer, and will test ProLindac in combination with taxol in this patient population. The protocol has been approved, sites have been identified and gone through their approval processes, and we expect the first patients to be enrolled and treated very shortly.
OIR - What is the potential for ProLindac, and what makes you optimistic about its chances for success?
First, you should know that “platinum-based” chemotherapies have been around for 30 plus years, and they are one of the most clinically successful, and commercially successful, classes of chemotherapies. The first two platinum chemotherapies, called cis-platinum and carbo-platinum were initially Bristol Myers Squibb drugs, which are still well used in generic form today. The third and most recently approved platinum is called Eloxatin, and it was available through Sanofi-Aventis. As far as we know, ProLindac is the only new platinum drug that is in active clinical development at this stage.
What makes ProLindac different from some recent platinum failures is that we are not trying to do something that is entirely “innovative” in nature. Access simply took the same active drug in Sanofi’s Eloxatin, called DACH platinum, and came up with an innovative delivery mechanism that enables us to deliver more DACH platinum to the patient, in a more tolerable way. It’s a traditional “drug delivery” strategy, using Access proprietary polymer delivery platform. One of the problems with platinum chemotherapies, including Eloxatin, is that they are difficult for the patients to tolerate. In our prior human trials, Access was able to deliver more of the active platinum drug to the patients, in a very well tolerated way, which makes us very optimistic about its prospects in upcoming trials.
OIR - What is your longer term plan with ProLindac?
We believe ProLindac’s commercial potential is measured in the billions of dollars, as Sanofi’s Eloxatin sold between $2 and $3 billion at its peak. For a drug of that potential, Access will need a large pharma development partner to run the confirmatory Phase 3 trials and finalize a drug approval strategy. Access has been discussions, and will continue to seek a large pharma partner for ProLindac. In the past year or so, Access has signed partnerships for ProLindac with leading pharma companies in China and Korea, which have agreed to pay for the next three pivotal trials for ProLindac, which are currently in the process of development right now.
Thiarabine
OIR - What is Thiarabine, and what is the product development program?
Thiarabine is Access’ proprietary treatment for various leukemias and lymphomas. It is in a class of compounds called nucleoside analogues, which are very commonly used in the treatment of different forms of leukemias and lymphomas, or blood cancers. Access licensed this compound into the Company from the Southern Research Institute at the University of Alabama at Birmingham. Thiarabine had previously been in two Phase 2 human trials in patients with solid tumors, where there was evidence that it would be better suited to blood cancers. Under the watchful eye of Dr. Hagop Kantarjian, Chair of the Leukemia Department at the MD Anderson Cancer in Houston, Texas, Access has recently initiated a dose-escalating Phase 1/2 trial at that site in leukemias and lymphomas. Dr. Kantarjian has significant experience in the development of this class of compounds, and has run and continues to run many clinical trials at MD Anderson in this patient population. We are very optimistic about the prospects for Thiarabine, and will have additional updates on progress of that trial throughout the year.
OIR - Jeff Davis, Thanks for your time.
Michael W Sweeney
Furthered Cobalamin-Mediated Formulation Interest Leads to New Patent Filings and CobOral Branding
Access Pharmaceutical (OTCBB: ACCP) has had nice run over the past few weeks.
Today, ACCP put out a press release that Access has rebranded its Cobalamin-mediated oral drug delivery technology as CobOral™ delivery technology, and they submitted additional patent applications:
"its Cobalamin-mediated oral drug delivery technology formulations of many global top-100 injectable drugs, as a result of the growing interest surrounding the company's proprietary oral delivery technology."
An improved CobOral insulin-containing nanoparticle formulation delivered orally provided a pharmacological response (lowering of blood glucose levels in an animal model of diabetes) equivalent to greater than 80% of that achieved by insulin delivered subcutaneously. Adaptation of this technology has provided a CobOral HGH formulation that has demonstrated good efficacy, represented by more than 25% improvement in weight gain, when given orally in an established animal model.
The patents cover oral formulations of leading injectables including:
- bevacizumab (Avastin®),
- trastuzumab (Herceptin®),
- adalimumab (Humira®),
- etanercept (Enbrel®),
- insulin glargine (Lantus®).
Jeffrey B. Davis, President and CEO, Access Pharma stated,
"The CobOral branding and additional patent filings reflect the high level of interest from partners in our CobOral and CobaCyte drug delivery platforms," stated As we continue exploiting our CobOral and CobaCyte technology platforms to yield valuable oral formulations of top-selling injectables, we believe filing these additional patents is critical in maintaining our strong IP position when further executing on our collaboration and partnering strategy."
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™, for the management of patients with mucositis, ProLindac™, currently in Phase II clinical testing of patients with ovarian cancer, and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.
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