DALLAS, July 29 ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), announced today that it is evaluating strategic options for the commercialization of MuGard in North America. MuGard is an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy, and previously announced data suggest that the market for MuGard is significantly greater than previously expected. Frank Jacobucci, formerly President & CEO of Milestone Biosciences, has joined Access as a consultant, and will assist with ongoing reimbursement, manufacturing and commercial launch activities at Access, while discussions with potential licensee and co-promotion partners is ongoing.
"Access is focused on maximizing the potential of MuGard, both for patients and for its shareholders," states Jeffrey B. Davis, Access' President & CEO. "Bringing MuGard back in-house will enable Access to capture more of MuGard's value for shareholders, and be more intimately involved in the ongoing commercialization activities. I welcome the expert insight and experience of Frank Jacobucci, who brings great knowledge and expertise in launching pharma products, with a particular expertise in oral mucositis and related indications, and of course MuGard."
Mr. Jacobucci has over 20 years experience in sales management, including senior sales executive positions at oncology focused companies including MGI Pharma, Genetics Institute, Wyeth Oncology, Aventis, Precision Therapeutics and CRC Oncology Services.
"I have always known the substantial potential for MuGard in the prevention and treatment of oral mucositis as well as it being very important for the medical community, and an exciting commercial opportunity in the pharma sector," stated Frank Jacobucci. "I look forward to working with the Access team while preparing for a MuGard launch in North America and bringing additional pharma resources to bear as needed. These efforts will not only maximize the potential for MuGard but, more importantly, provide access and availability for patients; thus improving outcomes I continue to believe that MuGard is a very important product for the cancer community, as the negative impact of oral mucositis on patient health and treatment is very significant."
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. 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.
The previously announced licensing agreement between Access and Milestone Biosciences, LLC for North American rights to MuGard has been terminated.
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/ 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.