Date: 2014-08-07
Type of information: Licensing agreement
Compound: MuGard™
Company: Access Pharmaceuticals (USA - TX) Norgine (The Netherlands)
Therapeutic area: Cancer - Oncology - Inflammatory diseases
Type agreement: licensing agreement
Action mechanism: MuGard™ is a viscous, mucoadhesive rinse which provides a protective coating to the oral mucosa. The product has been formulated to adhere to the mucosal surface of the mouth and thereby forms a soothing, protective layer. MuGard™ has received marketing allowance in the United States under a 510(k) from the FDA, and a CE Mark in Europe. In Europe, MuGard™ is indicated for “the prevention and management of the lesions and the symptoms of oral mucositis”. In the US, MuGard™ is marketed by AMAG Pharmaceuticals, under a license agreement with Access announced on June 10, 2013. MuGard™ is also licensed in China, RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
Disease: oral mucositis
Details: * On August 7, 2014, Access Pharmaceuticals, an emerging biopharmaceutical company, announced that it had entered into an exclusive license agreement with Norgine, a leading independent European specialty pharmaceutical company, for the commercialization of MuGard™ in Europe. Norgine will develop, manufacture, and commercialize MuGard in the European Union, Switzerland, Norway, Iceland and Lichtenstein. Norgine anticipates launching MuGard™ in 2015. Jeffrey Davis, CEO of Access Pharmaceuticals, Inc stated : \"With product offerings in complementary therapeutic areas and an established presence in the cancer supportive care space, Norgine is an ideal partner for us and we believe this partnership will drive commercial adoption in Europe and facilitate access of a proven treatment option to help protect patients from oral mucositis, a debilitating side effect. MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis 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.
Financial terms:
Latest news: Under the terms of the license agreement, Access will receive up to $10 million in milestone payments and an escalating double digit royalty on the net sales of the oral mucositis product, MuGard, in the licensed territories.
