Access Pharmaceuticals, Inc has entered into an agreement with a leading commercial manufacturer to produce its FDA-approved MuGard for North American distribution. One or more US market seeding studies could begin as early as Q4 2009, the company said.
In a comparison of cancer patients receiving standard oral mucositis care with those patients receiving MuGard, MuGard has been shown to significantly reduce the incidence and severity of the debilitating side effect of radiation treatment and chemotherapy.
Access has contracted with Accupac, Inc to serve as its commercial manufacturer of MuGard in North America. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world's largest pharmaceutical and consumer products companies.
"Access is moving forward with the development of MuGard in North America," said Jeffrey B Davis, Access' president & CEO. "Establishing our relationship with Accupac, a leader in liquid contract manufacturing, is critical to our successful commercialization of MuGard. In addition, Access is currently evaluating potential eMarketing partners as well as potential co-promotion or other licensing opportunities."
Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed. Access hopes to finalize these protocols and begin one or more market seeding studies in Q4 2009.
MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis. MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. Up to 80 per cent of all patients receiving radiotherapy and approximately 40 per cent of all chemotherapy patients develop oral mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop symptoms. MuGard is currently being marketed in the United Kingdom, Germany, Italy, Norway and Greece by Access' partner, SpePharm.
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, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion worldwide.
Access Pharma is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients.