Access Pharmaceuticals Inc (OTC: ACCP.OB) has completed its first commercial scale production run of MuGard in North America. The company intends to use the initial batches for pre-launch key institution evaluations, as preliminary stock for select wholesalers and specialty distributors, and for additional post-approval studies.
MuGard is an FDA-approved oncology supportive care treatment in the form of an oral wound rinse. It is used for the management of oral mucositis, a painful inflammation and ulceration of the mucous membranes which is a debilitating side effect of radiation treatment and chemotherapy.
Access Pharmaceuticals Sales and Marketing VP Frank Jacobucci commented:
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 re-imbursement 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.
The MuGard shipment was manufactured by contractor Accupac Inc, at its manufacturing facilities outside Philadelphia. Accupac is a contract manufacturer of a wide range of products for pharmaceutical and consumer products companies.
The drug has already been launched in the U.K., Germany, Italy, Sweden, Norway and Greece through Access’ European partner SpePharm. Additionally, the company’s Korean licensee, JCOM, has received approval from the Korean Food and Drug Administration (KFDA) for MuGard and it plans a commercial launch later this year.
Access estimates the market for the treatment of oral mucositis to be in excess of US$1 billion worldwide.
Disclosure: No positions