Access Pharmaceuticals (Access) has provided an update on its North American commercial launch of MuGard, an FDA approved treatment for oral mucositis. Access plans to commercially launch MuGard in North America in the first quarter of 2010.
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.
The company is currently working with its contract liquid manufacturer, Accupac, on initial clinical and stability batches, and expects to have initial commercial quantities available in 1Q 2010.
Access is working to develop a strategy for post-approval studies if and as needed. Access believes that its approved label indication and directions for use supports positioning MuGard as a preventative for oral mucositis caused by radiation and chemotherapy treatments, and provides for expansion into treatment of all types of oral wounds including aphthous ulcers, canker sores and traumatic ulcers, such as those caused by oral surgery.
In addition, Access continues to seek potential co-promotion arrangements with pharmaceutical and biotechnology companies in the oncology and oncology supportive care fields. Access believes that it can reach a targeted radiation oncologist community while still seeking broader distribution relationships.
MuGard is commercially launched by Access’ partner, SpePharm, in five European countries, having been granted the CE mark certification in October 2008 with the labeling “prevention and management of the lesions and symptoms of oral mucositis.”
The company said that introduction of MuGard into France, Central and Eastern Europe, the Benelux countries and the rest of Europe is anticipated over the next 12 to 18 months.
Frank Jacobucci, consultant at Access, said: “Access is on track for an early 2010 commercial launch of MuGard, and we look forward to bringing this important oncology supportive care treatment to the US market. With the launch of MuGard, we believe clinicians will have a welcome addition to their oncology supportive care arsenal, filling a significant unmet medical need for a treatment of oral mucositis.
“I have always known the substantial potential for MuGard in the prevention and treatment of oral mucositis, as well as an exciting commercial opportunity in the pharma sector.”