NEW FDA-APPROVED TREATMENT FOR ORAL MUCOSITIS
DALLAS, - ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), announced today that MuGard(TM), its proprietary oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care. The Company has previously announced commercialization agreements in North America, China and eight Southeast Asian countries and Korea, and is actively seeking additional marketing partners in other regions; MuGard expects commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement gets established regionally.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiation therapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
"Access is pleased with the commercial launch of MuGard in Europe, and the progress made by our partners in other regions of the world," said Phillip Wise, Vice President of Business Development at Access. "Access is also working with its partners outside of Europe to establish GMP manufacturing and secure necessary approvals and/or reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option," he continued.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
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