Access Pharmaceuticals, Inc, has received issue notifications from the United States Patent and Trademark Office that two US patents relating to MuGard, the company's approved oral rinse product for the management of mucositis will issue in June as US Patent numbers 7,544,348 and 7,547,433. MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments.
Access announced that MuGard was launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm. Under a license from Access Pharmaceuticals Inc, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. The license agreement includes royalties on net sales to Access.
"SpePharm and Access are pleased with the commercial launch of MuGard in Europe, and while it is still in the early days, initial feedback has been positive," said Phillip Wise, vice president of Business Development at Access. "SpePharm is working hard to secure 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 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 per cent of all patients receiving chemotherapy and/or radiotherapy 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.
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.