DALLAS and NEW YORK, April 13 ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced that it has completed its first commercial scale production run of MuGard in North America at Accupac, Inc. manufacturing facilities outside Philadelphia. Access intends to use the initial batches of MuGard for pre-launch key institution evaluations, preliminary stock for select wholesalers and specialty distributors, and additional post-approval studies to be conducted in the U.S. pursuant to guidelines and protocols that are currently being developed. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world's largest pharmaceutical and consumer products companies. Access' MuGard is FDA-approved for the management of oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.
"Access is pleased with the pre-launch progress for MuGard, and the successful completion of our first commercial scale production run at Accupac is a key step to making MuGard product available here in North America," states Frank Jacobucci, Vice President Sales and Marketing for Access Pharmaceuticals, Inc. "In addition to working with reimbursement consultants to better position MuGard with payers and providers, Access is currently developing plans for additional studies with key opinion leaders and key cancer centers. We also look forward to additional opportunities to share clinical experiences and data throughout 2010."
As previously announced, MuGard has been launched in the UK, Germany, Italy, Sweden, Norway and Greece through its European partner, SpePharm. Additionally, JCOM, Inc., its Korean licensee for both MuGard(TM) and ProLindac(TM), has received approval from the Korean Food and Drug Administration (KFDA) for MuGard and plans a commercial launch 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 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.
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.
Company Contact: ---------------- Christine A. Berni Director of Investor Relations Access Pharmaceuticals, Inc. (212) 786-6208 Contact: Investor Relations --------------------------- Donald C. Weinberger/Diana Bittner (media) Wolfe Axelrod Weinberger Assoc. LLC (212) 370-4500
SOURCE Access Pharmaceuticals, Inc.