Drug, which is already on the European market, will enter the U.S. through market-seeding studies.
Accupac has been contracted to manufacture Access Pharmaceuticals’ MuGard, an FDA-approved drug for treating oral mucositis in cancer patients. Accupac will produce the therapy for North American distribution. Initial batches will be used in market-seeding studies in the U.S.
“In addition, Access is currently evaluating potential eMarketing partners as well as potential co-promotion or other licensing opportunities,” reports Jeffrey B. Davis, Access’ president and CEO.
Access would like to begin one or more market-seeding studies in the U.S. with MuGard before the end of the year. Protocols are currently being developed, and a final version is expected in the fourth quarter.
MuGard is a mucoadhesive oral wound rinse for the management of oral mucositis in cancer patients who are undergoing chemotherapy or radiation. It is currently being marketed in the U.K., Germany, Italy, Norway, and Greece by Access’ partner, SpePharm.
In July Access reported that the licensing agreement with Milestone Biosciences for MuGard in North America had been canceled. At the time Frank Jacobucci, formerly president and CEO of Milestone Biosciences, joined Access as a consultant to assist with reimbursement, manufacturing, and commercial activities at Access. The original distribution deal was inked in August 2008.