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Access Pharma (OTCQB:ACCP) provided an update Wednesday on the status of its FDA cleared treatment for oral mucositis, MuGard. The drug's North American commercial launch is expected to occur during 1Q10 in conjunction with the availability of initial product inventory by its liquid contract manufacturing partner, Accupac. In addition, Access signed an e-marketing deal with iMedicor 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 deal and pending domestic MuGard launch are part of the company’s strategy that includes simultaneous discussions for potential co-promotion agreements with oncology-related bio-pharmaceutical companies and the development of a sales team with experience in the supportive treatment of cancer patients. Access is also working with consultants to finalize third-party reimbursement for MuGard from insurance plans, Medicare, Medicaid, etc.
iMedicor’s ClearLobby is an application within the NaviNet healthcare communications portal that includes a network of more than 700,000 physicians. Doctors, healthcare providers and support staff included in this network have the ability to access information on new medications and medical devices, in addition to medical / scientific journals, clinical trials, webinars and continuing education programs. Sponsored products such as MuGard go beyond simply providing information, including the capability to order samples and make specific inquiries about the product.
The combination of liquid contract manufacturing (Accupac), e-marketing (iMedicor), a dedicated oncology sales team and the pending post-approval marketing data from Europe positions Access to launch MuGard in North America on its own in a highly targeted and cost-efficient manner without giving away a large chunk of sales as part of a licensing agreement. In addition, the pending capital raise is likely to be in the $10-15 million range (40-60% of the $25 million maximum in the recent SEC S-1 filing) to further strengthen the balance sheet, fund the MuGard launch, and ultimately improve the company’s negotiating position for a potential MuGard co-promotion agreement(s).
Access Pharma's European MuGard partner, SpePharm, is currently collecting information from approximately 1,500-2,000 patients as part of a comprehensive set of post-marketing / seeding studies being conducted in the UK, Germany and Italy. SpePharm anticipates that data from these studies will be made on a rolling basis throughout late 2009 to early 2010 while the commercial launch of MuGard in France and other European countries will continue over the next 12-18 months. According to SpePharm, initial patient and clinician feedback has been very positive for MuGard, which validates interim data released from the UK study that demonstrated no cases of oral mucositis in 140 patients who received MuGard while undergoing treatment for head and neck cancer.
Access is also developing its own strategy for similar post-marketing studies in the U.S., if required, to support the use of MuGard as a preventative measure for oral mucositis arising from chemo / radiation therapy, in addition to expanding the scope of use for all types of oral trauma such as canker sores, ulcers, and oral surgery complications.
Disclosure: Long ACCP.OB
Source: Access Pharma Looking for Smooth U.S. MuGard Launch in 2010