DALLAS, Sept. 11 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) has entered into an agreement with a leading commercial manufacturer to produce its FDA-approved MuGard for North American distribution. One or more U.S. market seeding studies could begin as early as Q4 2009, the company says.
In a comparison of cancer patients receiving standard oral mucositis care with those patients receiving MuGard , MuGard has been shown to significantly reduce the incidence and severity of the debilitating side effect of radiation treatment and chemotherapy.
Access has contracted with Accupac, Inc. to serve as its commercial manufacturer of MuGard in North America. 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 is moving forward with the development of MuGard in North America," said Jeffrey B. Davis, Access' President & CEO. "Establishing our relationship with Accupac, a leader in liquid contract manufacturing, is critical to our successful commercialization of MuGard. In addition, Access is currently evaluating potential eMarketing partners as well as potential co-promotion or other licensing opportunities."
Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed. Access hopes to finalize these protocols and begin one or more market seeding studies in Q4 2009.
MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis. MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. 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 symptoms. MuGard is currently being marketed in the United Kingdom, Germany, Italy, Norway and Greece by Access' partner, SpePharm.
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 worldwide.
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 MuGard(TM) for the management of patients with oral mucositis and ProLindac(TM), currently in Phase 2 clinical testing of patients with ovarian cancer. ProLindac(TM) is also under study for its potential role in combination with other pharmaceuticals in the treatment of hepatocellular carcinoma (a form of liver cancer), and pancreatic cancer. The Company's pipeline also includes: 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 Stephen B. Thompson Vice President, Chief Financial Officer Access Pharmaceuticals, Inc. (214) 905-5100 Contact: Investor Relations Donald C. Weinberger/Diana Bittner(media) Wolfe Axelrod Weinberger Assoc. LLC (212) 370-4500
|SOURCE Access Pharmaceuticals, Inc.|
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