DALLAS, July 27 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced today that its European partner, SpePharm, has commenced commercial launch of MuGard in Norway. This follows previous commercial launches in the UK, Germany, Italy and Greece. Under a license from Access Pharmaceuticals, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard throughout Europe over the next 12 months, with direct launches planned in France, Spain and the Benelux countries, and launches through local distributors in Central and Eastern Europe. The license agreement includes royalties on net sales to Access.
Central to the MuGard commercial launch strategy is a coordinated effort to seek reimbursement from governmental agencies, placement in pharmacy formularies and an aggressive seeding strategy in leading cancer treatment centers and with leading clinicians. Aggressive sampling and education of patients and clinicians on early prophylactic use is proving important in reducing incidence, severity and duration of oral mucositis.
"The early feedback includes a high rate of enthusiasm and intention to continue use by practicing clinicians and patients, who have used MuGard," stated Jeffrey B. Davis, Access' President & CEO. "We believe this enhanced awareness of the benefits associated with use of MuGard as a preventative treatment is likely to result in solid marketing traction and market penetration in Europe as SpePharm continues market seeding studies in the major EU markets to continue to develop awareness within the medical community. Access continues to aggressively seek ways to maximize MuGard's potential for cancer patients and for its shareholders."
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 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, 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(R), 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/ Vice President, Diana Bittner (media) Chief Financial Officer Wolfe Axelrod Weinberger Assoc. LLC Access Pharmaceuticals, Inc. (212) 370-4500 (214) 905-5100
|SOURCE Access Pharmaceuticals, Inc.|
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