August 12, 2009
Jeffrey B. Davis (JD), President and CEO of Access Pharmaceuticals, Inc. recently conducted a Q&A with Mike Havrilla of BioMedReports.com (BMR) about the status and timeline for key upcoming milestones for the Company.
Here’s a brief excerpt from the interview:
BMR: What is the progress with obtaining an AMEX or Nasdaq listing and is this possible by year-end? Are the listing requirements met at this point?
JD: We have all the information into AMEX (NYSE Alternext) and NASDAQ contacted us proactively last week. I think its much much quicker than year end. We may need to get an exemption on net equity, but I think we’re fine (they’re focused on stock price and market cap, which we’re fine on).
BMR: When do you expect the final post-marketing study results for MuGard? Will these be submitted for journal publication and/or presentation at a conference?
JD: We should expect data from the UK marketing seeding studies in several weeks. SpePharm is doing additional seeding studies in Germany and Italy as well. So we should get a continuous stream of MuGard study data throughout the remainder of the year. As part of getting MuGard in the marketing assessment studies, the clinicians agree to publish in journals, scientific meetings, do posters, etc. I believe that Access should be able to initiate similar marketing assessment studies within 3 months in North America as well.
BMR: Do you expect to complete sale of EcoNail and/or Pexiganan before year-end?
JD: The guys at Piper Jaffray continue to work their process … and it’s hard to handicap. But discussions are ongoing.
BMR: What is the timeline for the two bio-pharma companies identified in mid-June to complete preclinical testing for your Company’s cobalamin drug delivery technology for oral insulin and enter formal licensing discussions? Will their results be made public regarding bioavailability of oral insulin?
JD: The results will definitely be made public. Again, it’s one North American biotechnology company, and one European biotech company. We’re providing the oral insulin – they are going to do an animal study each (one is planning to replicate our study in the rat model, one is doing dogs). Based on plans, we should have data in 3 months (we’ve sent the oral insulin, and it’s probably 6 to 8 weeks to run the study; and a couple weeks to tabulate the data, etc.). I’m leaving some slack time since it’s the end of August. Our ongoing discussions with them have been very positive (with respect to looking beyond insulin, into other potential drugs that they desire to use our Cobalamin drug delivery platform on).
BMR: Since Milestone agreement was cancelled, what is the plan and timeframe for US deal and/or launch of MuGard in US market?
JD: We’ve already met with one big pharma and one big biotech; we have more scheduled this month. Our strategy is to initiate GMP manufacturing of MuGard ourselves; continue to put the reimbursement strategy in place (get codes, etc.); and to go back to about 5 to 6 leading oral mucositis doctors to do US-based seeding studies. We will do this, and proceed “as-if” we are going to do the commercial launch ourselves – and our position with potential new North America partners is that they can do a new license deal (with better economics for Access, but give them control to do it all themselves), or a “co-promote” deal where Access retains the rights to co-promote MuGard in North America.
Finally, the Company is very excited about the prospects for MuGard, especially since nothing currently works very well for the prevention and/or treatment of oral mucositis (OM) and the potential market for the product is a large and growing one in both the U.S. and international markets. The link below provides a conservative estimate of the OM market at nearly 1 million patients per year on a global basis. However, Mr. Davis pointed out that, “You don’t really know in advance which chemotherapy patients (or radiation therapy patients) are most likely to get OM, therefore you can make the argument that MuGard can be used prophylactically.”
Click here to read the interview in its entirety.
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: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access’ plans to continue and initiate clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), its ability to achieve clinical and commercial success and its 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.
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