ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, announced that its MuGard partner in China, Rhei Pharmaceuticals HK Ltd., received regulatory and marketing approval for MuGard in China from the State Food and Drug Administration, or SFDA, to treat oral mucositis in cancer patients. Manufacturing of MuGard will commence shortly in the United States to meet the demand created by Jian An, Rhei's sales and marketing partner in China.
Last year, Access and RHEI signed a $30 million supply agreement for MuGard to ensure manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. In addition, Access also approved a sub-license agreement between RHEI Pharmaceuticals and Jian An Pharmaceuticals ("Jian An") Limited in Shenzhen, China to leverage Jian An's extensive sales, marketing and regulatory infrastructure for the launch of MuGard in China and Taiwan. Jian An is headquartered in Shenzhen, China and has a 25-year history of selling pharmaceutical and other medical products in the China market. Jian An has 1400 sales representatives covering all majors centers in China through 169 sales offices.
Expressing enthusiasm on the approval, Jeffrey B. Davis, President and Chief Executive Officer of Access Pharmaceuticals, Inc. stated, "Receiving final marketing approval from the SFDA of China is a transformative milestone for our global MuGard program. China represents a key target market with its large and increasingly affluent population and its desire for improved oncology care. With the approval process now complete, we look forward to moving as quickly as we can to complete manufacturing so Rhei and Jian An can launch MuGard through their well established sales and marketing infrastructure in China."
"China is one of the fastest growing oncology markets and cancer supportive care has been improving throughout recent years," said Sven De Backer, Chief Executive Officer, Rhei Pharmaceuticals HK Ltd.. He continued, "Rhei and Jian An are proud to bring MuGard to patients and physicians as we believe it is a critical and valuable product that addresses a significant unmet need for a large and growing patient population."
Access Pharmaceuticals, Inc.