Under the terms of the license agreement, Access will receive an upfront licensing fee and double digit royalties on net sales of MuGard in the licensed territory.
MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue.
Access Pharmaceuticals president and CEO Jeffrey B Davis noted Hanmi’s international presence, resources and strategic emphasis on expansion makes them an ideal partner for MuGard.
"With the recent publication of MuGard clinical data, completion of this third marketing partnership, and active discussions with additional partnerships abroad, Access is laying the foundation for MuGard growth globally," Davis added.
Access recently announced publication of positive MuGard clinical data in Cancer, the journal of the American Cancer Society. The publication is entitled ‘Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck’.
MuGard mucoadhesive oral wound rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.
MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the US Food and Drug Administration and is marketed by AMAG Pharmaceuticals in the US.