Access Pharmaceuticals Inc (OTC: ACCP) told investors that it is collaborating with Stephen T Sonis, a leading expert in oral mucositis, to further advance ongoing marketing and reimbursement efforts for its treatment for the condition, MuGard. As such, Dr Sonis and Access Pharma will develop a program to generate additional clinical data to further support the marketing and reimbursement initiatives for the US commercial launch of its lead product.
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.
"I am pleased that the introduction of MuGard will offer patients a new alternative to help control the painful symptoms of oral mucositis”, Dr Sonis stated. “Access' commitment to demonstrate MuGard's effectiveness through rigorous clinical trials will separate MuGard from other currently available oral rinses and gels and set a new standard for agents in this class”.
Dr Sonis will be the primary author on a study protocol aimed at obtaining specific data that will help further broaden the indication for MuGard, and support efforts geared towards enhancing payer uptake of MuGard.
Access Pharma chief executive Jeffrey Davis commented, "Dr Sonis has the ability to provide Access with critical insight into the conditions of OM, its impact on clinical outcomes, patient health and overall healthcare costs. We believe his counsel will be enormously valuable to us."
Dr Sonis is a Clinical Professor of Oral Medicine at Harvard, and he has published extensively on the biology, clinical impact, and health and economic ramifications of mucositis. He also acts as Chief of the Division of Oral Medicine at the Dana Farber Cancer Institute, and Program Director for Supportive Cancer Care at Clinical Assistance Programs.
Yesterday, Access announced it 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.
The drug has already been launched in the UK, 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: The author holds no positions in the company