Access Pharma's Korean Partner Gains Marketing Approval for MuGard
First Asian Approval Furthers Global Availability of Access' FDA-Approved Product for Management of Oral Mucositis
DALLAS, March 25, 2010 /PRNewswire via COMTEX/ -- ACCESS PHARMACEUTICALS, INC.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.
MuGard is a novel, ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
JCOM Co., LTD has operations in two areas, biotechnology and information technology. The Company's biotechnology division specializes in the manufacturing and distribution of medicine and various chemical pharmaceuticals, with a particular emphasis on biosimilars. The majority of the Company's pipeline is in the areas of diabetes/insulin, cancer, stem cells and horse cloning.
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include ProLindac(TM), currently in Phase II clinical testing of patients with ovarian cancer, and MuGard(TM) for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
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Access Pharmaceuticals, Inc. (212) 370-4500