Earlier this week, I had the opportunity to conduct a Q&A session for BioMedReports.com (BMR) with the President & CEO of Access Pharma (OTCQB:ACCP), Jeffrey B. Davis (JD), who provided the following information and updates regarding the status and timeline for key upcoming milestones for the Company.
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 it's 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.”
The Medscape eMedicine entry for Chemotherapy-Induced Oral Mucositis estimates that about 400,000 patients per year in both the U.S. and international markets may develop acute or chronic oral complications during chemotherapy. Some degree of OM occurs in about 40% of patients who receive cancer chemotherapy while at least 75% of patients who receive conditioning regimens (chemotherapy with or without total body irradiation) in preparation for hematopoietic cell transplantation (HCT) develop OM. The incidence is also higher in patients who receive continuous infusion therapy for breast and colon cancer and in those who receive adjuvant therapy for head and neck tumors. However, in patients of the same age with similar diagnoses and treatment regimens and equivalent oral health status, the incidence of OM may vary considerably as Mr. Davis points out above in his statement.
Based on National Cancer Institute statistics, the incidence (number of diagnoses) of cancer in the U.S. is expected to be about 1.5 million people in 2009. Please note this number does not even include any patients receiving chemo or radiation therapy who were previously diagnosed with cancer (prevalence includes individuals who are newly diagnosed, in active treatment, have completed active treatment, and those living with progressive symptoms of their disease). The World Health Organization (WHO) estimates that cancer rates (incidence) could further increase by 50% to 15 million new cases in 2020 from 10 million new cases diagnosed globally in 2000. Developed nations with the highest overall cancer rates include the U.S., Italy, Australia, Germany, The Netherlands, Canada, and France.
Upcoming milestones expected for Access Pharma include the following:
(1) Final results (all 280 patients over the entire seven-week duration) expected “in several weeks” for SpePharm's UK post-approval marketing study of MuGard with interim results demonstrating no cases of oral mucositis in 140 patients with head and neck cancer being treated with radiation therapy.
(2) Continuous flow of clinical data (including journal publications and presentations at medical/scientific conferences) for MuGard expected throughout 2H09 as SpePharm is also conducting post-approval marketing studies in Germany and Italy. Access also expects to initiate similar marketing assessment studies within three months (mid-November) in North America as well.
(3) Listing on either the AMEX or NASDAQ exchanges is expected to occur “much quicker than before year-end” timeframe with key requirements now met for share price and market cap.
(4) MuGard launch in Asia expected during 2H09.
(5) U.S. North American Commercialization Strategy for MuGard: Access has already met with one big pharma and one big biotech has more meetings scheduled for August. The Company’s strategy is to initiate GMP manufacturing of MuGard; continue to put the reimbursement strategy in place (get codes, etc.); and then go back to about 5-6 leading OM doctors to conduct US-based post-approval marketing studies. Access will proceed “as-if” preparing for a commercial launch alone while taking a position with potential new North America partners 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.
(6) During 2H09, the Company plans to start multiple Phase 2 clinical trials evaluating both ProLindac (Europe + Asia) and thiarabine (data expected mid-2010). Access intends to design all clinical studies of ProLindac in accordance with FDA standards and intends to use the clinical data from all three planned clinical trials in the Far East to further development in North America and Europe. Access has the right to all clinical data generated in the Far East under the agreements entered into with its partners in that region, and as previously announced, believes that these trials run by its ProLindac partners will save Access between $20-30 million in clinical development expenses.
(7) Discussions are ongoing for global and/or regional partnerships to develop and commercialize ProLindac with the final report pending for the Phase 2 ovarian cancer clinical trial conducted in Europe. In early August, Access announced the initiation of a new clinical study of ProLindac in France. The study will examine dose levels and regimens of ProLindac mono-therapy in cancer patients, provide additional data to support design of combination studies, and extend the safety database for the drug. Two ovarian cancer patients have been enrolled in the study to date, and the Company expects to enroll 6-12 patients this year before beginning to enroll patients in clinical trials evaluating ProLindac in combination with other chemotherapies (likely to involve ProLindac plus paclitaxel--Taxol and/or gemcitabine--Gemzar).
(8) Planned sale of the Company’s anti-infective dermatology assets (EcoNail - topical econazole and Pexiganan - a novel topical anti-infective) with ongoing discussions as Piper Jaffray continues to manage this process (the timeframe for completing this process is difficult to predict).
(9) Licensing discussions for the Company’s cobalamin-based nanopolymer drug delivery technology for the oral administration of a basal (long-acting) insulin product following mid-June announcement that two bio-pharmaceutical companies will conduct preclinical, animal studies before proceeding to more formal negotiations. The results of these preclinical studies will be made public, including one North American biotech company and one European biotech company. Access is providing the oral insulin while the two interested companies will conduct one animal study each (including a rat and dog model) with data expected in about three months. Ongoing discussions with these companies may result in the evaluation of other drugs utilizing this delivery platform, including human growth hormone (hGH) and erythropoietin (EPO).
Disclosure: Long ACCP.OB