Access planning full commercial availability by mid August Print E-mail
By M.E.Garza   
Thursday, 24 June 2010 11:21

As a follow up to our subscriber alert and article about Access Pharmaceuticals' (ACCP.OB) presentation at the Multinational Association of Supportive Care in Cancer (MASCC) Conference in Vancouver, B.C, BioMedReports reached out to the company for reaction and specifics regarding the commercialization of the company's FDA approved product, MuGuard.

The product has huge fnancial and medical potential and it has attracted the attention of several big players in the onocology pharmaceuticals space. Given today's earlier news, its clear that the company intends to educate the oncology medicine community about the product going forward, but sources have told BioMedReports in the past that the company could decide to sell the technology to one of those bigger pharma players- whose deeper pockets and marketing resources could help launch the product faster and on a much bigger scale.

Here now is our exclusive interview with Jeffrey Davis, CEO of Access Pharmaceuticals:

BioMedReports: What is MuGard?  Why is it important to the oncology community?

Jeffrey Davis, CEO of Access Pharmaceuticals: MuGard is Access Pharma’s FDA-approved treatment for oral mucositis (“OM”), a debilitating side effect of chemotherapy and radiation therapy.  Most people are aware that patients undergoing chemo or radiation for cancer will experience alopecia (or hair loss) and nausea and vomiting.  And now, for example, there are billion dollar markets with therapies for anti-nausea and vomiting.

Oral mucositis is an ulceration of the oral mucosa, or the skin in your mouth, tongue and down your esophagus (see photos below).  Its common, in so much as roughly 90% of radiation patients, and 40% of chemo patients will experience some form of it.  And, its 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 in turn leads 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 it’s utility in the potential prevention and ultimate treatment of patients with oral mucositis.

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

Jeffrey Davis, CEO of Access Pharmaceuticals: 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.

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

Jeffrey Davis, CEO of Access Pharmaceuticals: We excited to say that MuGard has launched in Europe through our EU partner SpePharm, is launching here in the US as we speak, and will launch in the Far East through our Korean marketing partner later in the year.  As far as US activities are concerned, we’ve spent recent months ramping up commercial production through our manufacturing partner, Accupac so that we have commercial product ready to go.  We’re working with reimbursement consultant to secure third-party payor reimbursement and get necessary reimbursement codes at the Federal level.  And, lastly, we’ve recently announced the MuGard Centers-of-Excellence Sampling Program, whereby we’re working with major oncology networks throughout the US to get MuGard sample kits in clinician’s and ultimately patient’s hands to build clinical experience and to work MuGard into the standard protocols of specific treatment regimens.

BioMedReports: What’s happening this week at the MASCC meeting?

Jeffrey Davis, CEO of Access Pharmaceuticals: MASCC is the Multi-national Association of Supportive Care in Cancer meeting happening this week in Vancouver, BC.  It’s one of the most important meetings of the year in the cancer supportive care area.  Access is represented there very well, and I think MuGard will be “the buzz” of the meeting.  First, on Tuesday, we’re sponsoring an Oral Mucositis symposium that brings leading clinicians and researchers in the area of oral mucositis together to share ideas and experiences on how to address the OM challenge.  Our Chief Scientist David Nowotnik will be there and will present some information on MuGard, and help spread the word on its clinical benefits.  On Thursday, Access and SpePharm have co-authored a scientific presentation on the global clinical experience with MuGard, which will reflect clinical data and information from the US clinical trial, the European clinical experience, as well as a separate evaluation done by our Chinese marketing partner, RHEI Pharmaceuticals.

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

Jeffrey Davis, CEO of Access Pharmaceuticals: 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 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.

BioMedReports: Any other observations from the clinical experience?

Jeffrey Davis, CEO of Access Pharmaceuticals: 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.

BioMedReports: When will MuGard be available in the US?

Jeffrey Davis, CEO of Access Pharmaceuticals: We are planning to have full commercial availability by August 15, 2010.  In addition to the steps mentioned above, we’re working with potential specialty distributors and other pharma detailing companies to help us raise awareness and make it available.  We continue to speak to potential co-promotion partners as well, both here and in “un-licensed” territories around the world, as we hope to make MuGard available as broadly as possible.


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