Access Pharmaceuticals, Inc. has announced that JCOM Co., Ltd., its Korean licensee for both MuGard(TM) and ProLindac(TM), has received approval from the Korean Food and Drug Administration (KFDA) of its Registration Dossier for MuGard, an oncology supportive-care treatment for the management of oral mucositis.
Under the agreement, JCOM is responsible for obtaining the necessary regulatory approvals for MuGard in Korea. As soon as JCOM has completed the additional steps required to import MuGard from the United States, marketing will commence.
"JCOM is a well-regarded company with an extensive distribution network in Korea," said Jeffrey Davis, CEO of Access Pharmaceuticals. Davis continued, "JCOM receiving technical approval is a critical step in the launch of MuGard in Korea and it fits in nicely with our broad commercialization strategy of MuGard in the global market. We look forward to working with them on next steps, including a potential supply arrangement, and to leveraging their expertise throughout the region." "We are pleased with the continued progress being made to commercialize MuGard in Korea," stated Mr. Yong Seok Kang, CEO of JCOM Co., Ltd. "We remain on track and look forward to commercializing actively in the second half of the year." As previously announced, MuGard has been launched in the UK, Germany, Italy, Sweden, Norway and Greece through its European partner, SpePharm.
Additionally, Access Pharmaceuticals and its respective marketing partners continue preparing for the commercial rollout of MuGard in the United States and additional countries in Europe, set for later this year.