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Access Pharmaceuticals Provides Update on MuGard Commercial Launch in Europe

DALLAS, Dec. 3 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), today provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. MuGard is commercially launched by Access' partner, SpePharm, in six European countries, including the UK, Germany, Italy, Norway, Greece and Sweden. Access is conducting pre-marketing activities, including ramping of commercial production, with the goal of a commercial launch in 1H 2010 in the US. MuGard was granted the CE mark certification in Europe in late 2008 with the labeling "prevention and management of the lesions and symptoms of oral mucositis." Key findings and feedback from SpePharm's ongoing commercial launch and patient assessment project include:

  • Over 15,000 bottles of MuGard have been used by over 2,000 patients since launch.
  • The European patient population includes adult patients undergoing radiotherapy and/or chemotherapy regimens.
  • Patients experience includes those being prescribed and using MuGard prophylactically, as well as those using MuGard following the onset of oral mucositis.
  • Initial feedback continues to reflect that MuGard is well accepted by both patients and healthcare professionals both as a preventative and curative treatment for oral mucositis.
  • Patients and healthcare professionals like MuGard's ready-to-use formulation, and believe it supports treatment compliance by patients.
  • SpePharm is currently gathering feedback from clinicians in the UK, Germany and Italy that are participating in a patient assessment project. SpePharm expects that out of a total of approximately 1,500 patients who will be given MuGard in this project, a consistent number of patient forms will be collected by year end, and the information will be quality checked for potential presentation at a scientific or medical conference or meeting in the first half of 2010.
  • Introduction of MuGard into several additional countries in Europe is anticipated over the next 12 to 18 months.

"As of today, more than 2,000 cancer patients undergoing radiotherapy and/or chemotherapy have been treated with MuGard," stated Jean-Francois Labbe, SpePharm's President & CEO. "We are very pleased with progress to date, and MuGard is well accepted by patients and by healthcare professionals, both as a preventative and curative treatment. MuGard's ready-to-use formulation helps to support treatment compliance by the patients, and we believe is leading to its adoption as treatment-of-choice to prevent and treat oral mucositis."

"Access is pleased with the early acceptance of MuGard as a preventative and curative treatment for oral mucositis," stated Jeffrey Davis, Access' President & CEO. "We hope to be able to leverage SpePharm's early experiences around its launch in Europe to jump start our efforts here throughout the remainder of the year and into 2010."

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 80% of all patients receiving radiotherapy and approximately 40% of all chemotherapy patients develop oral mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop oral mucositis. The market for the prevention and treatment of oral mucositis, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion worldwide. MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac(TM), currently in Phase 2 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

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: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access' plans to continue and initiate clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), its ability to achieve clinical and commercial success and its 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.

Contact: Company                Contact: Investor Relations
Stephen B. Thompson             Donald C. Weinberger/Diana Bittner (media)
Vice President,                 Wolfe Axelrod Weinberger Assoc. LLC
 Chief Financial Officer        (212) 370-4500
Access Pharmaceuticals, Inc.
(214) 905-5100

SOURCE Access Pharmaceuticals, Inc.

SOURCE Access Pharmaceuticals, Inc.
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