ARTICLE | Clinical News

MuGard regulatory update

July 11, 2011 7:00 AM UTC

Access Pharmaceuticals said partner Rhei Pharmaceuticals Inc. (Hong Kong, China) received an acceptance letter from China's State Food and Drug Administration (SFDA) for MuGard mucoadhesive oral rinse to treat and prevent oral mucositis (OM). Rhei expects to receive marketing approval for the product from SFDA this half. The acceptance triggered an undisclosed milestone payment from Rhei to Access.

Rhei has rights to commercialize MuGard in China, Hong Kong, Macau, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanamar, the Philippines, Singapore, Thailand and Vietnam from Access under a 2008 deal. Additionally, Rhei granted Jian An Pharmaceuticals Ltd. (Shenzhen, China) an exclusive sublicense to commercialize MuGard in China and Taiwan. ...