Ahead of the expected 1Q10 North American commercial launch for MuGard, Access Pharma (OTCQB:ACCP) announced yesterday that it appointed Frank Jacobucci as VP of Sales and Marketing. Mr. Jacobucci will lead the marketing effort for MuGard in North America and has over 20 years of sales management experience, including a focus on products for the treatment and supportive care of cancer (including specific knowledge and experience with MuGard) at companies such as MGI Pharma (acquired by Eisai, OTC: [[ESALY.PK[[), Wyeth Oncology, and Aventis (now Sanofi-Aventis, NYSE: [[SNY[[).
Below is a summary of a phone interview Q+A that I conducted with the President / CEO of Access, Jeffrey B. Davis, on Monday afternoon to provide an update on expected upcoming milestones, catalysts, and recent developments for the company.
1.) What is the current status and strategy for the commercial launch of MuGard in North America?
There are really four distinct areas surrounding the commercial launch of MuGard in North America, which include manufacturing, reimbursement, sales / marketing, and the clinical advancement program.
As previously announced, Access has hired Accupac, which is a leading contract drug manufacturer that focuses on liquid products. The first commercial scale product for MuGard is expected during 1Q10, including approximately 100,000 bottles by late Feb-early March that will be targeted toward key opinion leaders and high-volume radiation oncologists who specialize in the treatment of head and neck cancer (due to the very high incidence of treatment-associated mucositis in this patient population).
Regarding reimbursement and sales strategies, Access is currently executing on a number of strategies pertaining to both third-party payer reimbursement and Medicare / Medicaid reimbursement, as well as making sure it has a dedicated marketing and sales organization in place to reach the initial target market of both radiation oncologists (especially those that treat head and neck cancer) and large oncology networks.
With respect to MuGard clinical advancement program, Access has met with key oral mucositis (OM) opinion leaders and expects to make some announcements shortly which should shine some light on the advantages of MuGard as both a preventative and curative option for OM.
In addition, Access signed an e-Marketing deal with iMedicor (OTC: VMCI.OB) in early October as a cost-efficient and highly targeted means of reaching over 200,000 oncologists in the U.S. market. The e-Marketing effort is part of the company’s strategy that includes simultaneous discussions for potential co-promotion agreements (including an update on Canada that is expected shortly) with oncology-related bio-pharmaceutical companies and the development of a sales team with experience in the supportive treatment of cancer patients.
2.) What is the status of MuGard in Europe and Asia?
As previously announced, SpePharm is very pleased with the launch to date … so we’re very pleased as well. The reception of MuGard has been good as clinicians and patients are happy, and SpePharm is preparing to launch in additional EU countries outside of the six countries where it’s currently marketed (UK, Germany, Italy, Norway, Sweden, Greece).
SpePharm has expanded the MuGard post-marketing studies and now expects up to 2,000 patients to be assessed in the study. As stated in a recent release, MuGard is being well accepted both as a preventative and a curative treatment, and SpePharm hopes to present MuGard information at a medical or scientific conference in early 2010 (i.e. possibly ASCO). Clearly, the key is getting clinicians to prescribe it as a preventative, or for prophylactic use and for the patients to use it that way.
It should be noted that SpePharm has different priorities as a privately held company and the patient feedback assessments have been collected more slowly than originally anticipated. Therefore, the original plan for releasing the results of the MuGard post-marketing studies starting during 4Q09-1Q10 has shifted to presentation at an appropriate medical conference next year.
3.) What is the key factor that will determine success of the MuGard commercial launch in North America?
As outlined previously, the key will be getting both clinicians and patients to think about oral mucositis just as they think today about preventing or treating emesis, or nausea and vomiting. Now, before one goes in for their first treatment of chemo, their clinician will write them a script for an anti-emetic drug – or something to prevent or treat nausea and vomiting.
Until MuGard, clinicians did not have something that was indicated for prophylactic or preventative use for OM; so they’d wait until the patient presented with the condition and then prescribe something palliative, usual some liquid form of painkiller, like lidocaine in a saline solution or magic mouthwash / MBX solution (a combination of Mylanta, Benadryl and lidocaine).
MuGard’s approved label suggests using MuGard prior to their cancer treatment and it says that the product is safe to swallow, which is key, because some of the most painful lesions are the lesions or ulcers tend to occur in the throat. We believe these two items are key, “preventative or prophylactic use” and “safe to swallow.”
4.) Are there any other updates or new developments to report?
As we’ve mentioned in the past, we’re about to start the first combination trial for ProLindac, and we will have some additional news and details on that clinical trial shortly. The company’s director of clinical development, Esteban Cvitkovic, is excited about these new indications (i.e. first or second relapse patients with recurrent ovarian cancer), and believes that they represent a much quicker registration pathway to approval in Europe, and possibly the U.S., than going after colorectal cancer.
Access is currently working with leukemia and lymphoma specialists to initiate additional Phase 2 pilot studies during 1Q10 in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and B-Cell lymphomas. These pilot studies will seek to determine the optimal dosage regimen and most susceptible malignancies for future trials to serve as the basis for partnership discussions for further development and commercialization.
Disclosure: Author holds a long position in ACCP.OB