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Access Pharmaceuticals Provides Update on MuGard Commercial Launch in North America

DALLAS, Nov. 11 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), today provided an update on its North American commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. Access intends to commercially launch MuGard in North America in the first quarter of 2010. Key strategic items pertaining to the launch include:

  • Manufacturing: Access is currently working with its contract liquid manufacturer, Accupac, on initial clinical and stability batches, and expects to have initial commercial quantities available in 1Q 2010.
  • Reimbursement: Access is working with outside regulatory consultants in developing and finalizing its reimbursement strategy as it pertains to third-party payors and Medicare/Medicaid.
  • Clinical: Consistent with strategies employed by its global marketing partners, Access is working with key opinion leaders to develop a strategy for post-approval studies if and as needed. Access believes that its approved label indication and directions for use supports positioning MuGard as a preventative for oral mucositis caused by radiation and chemotherapy treatments, and provides for expansion into treatment of all types of oral wounds including aphthous ulcers, canker sores and traumatic ulcers, such as those caused by oral surgery.
  • Marketing/Sales: Access has signed a deal with iMedicor to support online eMarketing efforts and education of oncologists, radiation oncologist and support staff as it pertains to oral mucositis and MuGard specifically. Access intends to build a hybrid, dedicated salesforce with oncology supportive care experience.
  • Co-Promotion: Access continues to seek potential co-promotion arrangements with pharmaceutical and biotechnology companies in the oncology and oncology supportive care fields. Access believes that it can reach a targeted radiation oncologist community while still seeking broader distribution relationships.

"Access is on track for an early 2010 commercial launch of MuGard, and we look forward to bringing this important oncology supportive care treatment to the US market," stated Frank Jacobucci, a consultant to Access, and previously CEO of Milestone Biosciences. "With the launch of MuGard, we believe clinicians will have a welcome addition to their oncology supportive care arsenal, filling a significant unmet medical need for a treatment of oral mucositis. I have always known the substantial potential for MuGard in the prevention and treatment of oral mucositis, as well as an exciting commercial opportunity in the pharma sector." 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.

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.

MuGard is commercially launched by Access' partner, SpePharm, in five European countries, having been granted the CE mark 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.

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, Chief          Wolfe Axelrod Weinberger Assoc. LLC
     Financial Officer             (212) 370-4500
    Access Pharmaceuticals, Inc.
    (214) 905-5100

SOURCE Access Pharmaceuticals, Inc.

SOURCE Access Pharmaceuticals, Inc.
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