DALLAS, Oct. 15 /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 five European countries, having been granted the CE mak certification in October 2008 with the labeling "prevention and management of the lesions and symptoms of oral mucositis." 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 1500 to 2000 patients who will be assessed in this project, a subset of patient forms will be collected by year end, and aggregated clinician and patient feedback will continue to be available on a rolling basis during the fourth quarter 2009 and 2010. Introduction of MuGard into France, Central and Eastern Europe, the Benelux countries and the rest of Europe is anticipated over the next 12 to 18 months.
"SpePharm is very pleased with the commercial launch of MuGard thus far, and I am happy to report that initial clinician and patient feedback has been very positive," stated Jean-Francois Labbe, SpePharm's President & CEO. "Our intention is to continue to gather clinician and patient feedback, and use this information to expand our presence throughout Europe. MuGard faces limited competition in Europe as traditional palliative solutions offer limited efficacy and/or poor compliance."
"As Access prepares for the MuGard commercial launch in North America, we look forward to close cooperation with our European partner particularly with respect to planned market assessments studies here in the US," 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. Access' recently announced agreements with Accupac in manufacturing and iMedicor with e-marketing and education reflect our commitment to the MuGard launch."
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 mucositis. The market for the treatment of oral mucositis, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion world-wide. 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.
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; Angiolix®, a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; 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: 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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