Access Pharma Completes First North American MuGard Production

Access plans to use the initial batches of MuGard for pre-launch key institution evaluations, preliminary stock for select wholesalers and specialty distributors, and additional post-approval studies to be conducted in the US pursuant to guidelines and protocols that are currently being developed.

Access’ MuGard is FDA-approved for the management of oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.

Frank Jacobucci, vice president of sales and marketing at Access Pharmaceuticals, said: “Access is pleased with the pre-launch progress for MuGard, and the successful completion of our first commercial scale production run at Accupac is a key step to making MuGard product available here in North America.

“In addition to working with reimbursement consultants to better position MuGard with payers and providers, Access is currently developing plans for additional studies with key opinion leaders and key cancer centers. We also look forward to additional opportunities to share clinical experiences and data throughout 2010.”

Reportedly, MuGard has been launched in the UK, Germany, Italy, Sweden, Norway and Greece through its European partner SpePharm. Additionally, JCOM, its Korean licensee for both MuGard and ProLindac, has received approval from the Korean Food and Drug Administration (KFDA) for MuGard and plans a commercial launch later this year.