Access Pharmaceuticals Provides Update on MuGard Commercial Activities

DALLAS and NEW YORK, May 17, 2011 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, announced that it had made significant progress with the commercial introduction of MuGard in the radiation oncology and medical oncology communities.  MuGard is a novel, ready-to-use mucoadhesive oral wound rinse and coating that has been shown to be very effective in the management of oral mucositis, a debilitating side effect of many anticancer treatments.  Access provided the following information related to its ongoing commercialization efforts:

• Salesforce Management:  At the end of 2010, Access commenced training of third-party MuGard representatives on the product, the oral mucositis condition and sales strategy.  These reps initiated a broad-scale marketing push that will continue throughout 2011.  While greater than 90 reps have received initial MuGard training, efforts to identify and train additional representatives in uncovered or under-resourced geographic areas will also remain a focus throughout the year.

• MuGard Prescriptions Ramping:  MuGard prescriptions have been ramping consistently for the last several weeks, starting from 10 prescriptions per week and growing to greater than 75 prescriptions per week.  Over 200 doctors to date have prescribed MuGard for their patients and over 80% of these doctors are reoccurring prescribers.  Access believes it has the right team and resources in place to continue ramping prescriptions throughout the year.

• Reimbursement Activities:  The Company has placed a significant emphasis on its sampling and marketing efforts to build demand, grow oncologist awareness and increase payer uptake. To date, Access has received nationally recognized insurance reimbursement, including select state and Federal plans from Blue Cross Blue Shield, United Healthcare, Humana, Anthem and Medicaid.  Access has allocated additional resources to address reimbursement needs with the recent hiring of Anthony Mottola, Vice President of Managed Care and Market Access, and anticipates announcing the addition of outside groups to assist in ongoing aggressive third party payer outreach programs, and distribution activities.

• Commitment to Clinical Excellence:  Given the significant clinical benefit of MuGard to all cancer patients suffering with oral mucositis, Access is committed to providing access to MuGard for all patients during its initial commercial introduction of the product.  The goal of this effort is to build nationwide clinical experience at the oncologist, nurse practitioner, nurse and patient levels, such that the oncology community continues to write MuGard prescriptions and experiences the significant clinical benefits of MuGard.  As reflected below and on the testimonial page of the MuGard website, Access is pleased to report that clinical feedback on MuGard from healthcare providers and patients has been extremely positive in a broad spectrum of clinical settings, treatment regimens and tumor types.

• Manufacturing and Distribution:  The significant prescription ramp and MuGard access program has required Access to initiate, earlier than expected, its second commercial manufacturing run of MuGard product.  Access will produce approximately four times as much MuGard product during this second commercial production run to meet the ongoing demands of the market.  Additionally, Access is exploring additional wholesaling and specialty distribution arrangements nationwide, consistent with anticipated production and product revenue levels.

• MuGard Clinical Data:  Access is driving additional reimbursement nationally through both commercial acceptance and demand for the product, and supplementary MuGard clinical data.  Additional MuGard clinical studies, both investigator sponsored and otherwise, in the US and abroad, are ongoing or completed, and Access anticipates announcements of clinical data, including that from randomized and controlled clinical trials, throughout 2011 and 2012.

Access continues to collect clinical data and anecdotal feedback from clinicians, nurses and patients across the US.  Recent testimonials, all of which will be included in the testimonial page of www.MuGard.com, include the following:  

"Access is extremely pleased with the initial progress of the commercial roll-out of MuGard," stated Jeffrey B. Davis, President and CEO, Access Pharmaceuticals.  "Clinical feedback has been extremely positive, and we as a Company remain committed to getting this very important treatment option to doctors, nurses and patients.  Oral mucositis, while not widely understood by the investing public, is a very large and growing healthcare unmet clinical need; MuGard meets that need."

"The MuGard prescription ramp is exceeding my expectations," said Frank Jacobucci, Vice President of Sales and Marketing for Access Pharmaceuticals.  "Access continues to identify and train additional MuGard representatives to further expand our footprint in the US, and believes this will add significantly to current prescription growth, clinical experience and general MuGard awareness."

"The very positive clinical feedback and commercial uptake of MuGard had a significant impact on my decision to join Access Pharmaceuticals," stated Anthony Mottola, Vice President, Managed Care and Market Access.  "I am spearheading internal efforts to expand third party payor outreach, enhance our nationwide distribution capabilities, and add certain components to our offering such as hotline services and additional hub and distribution capabilities.  We will announce additional collaborations in this area as they occur."

Investor Conference Call Details:

An investor conference call is scheduled to be held on Tuesday, May 24, 2011 at 11:00 am EDT.  Interested parties may participate by dialing 877-407-4019 (US) or 201-689-8337 (International) approximately five to ten minutes before the call start time.  A replay of the call will be available starting on May 24, 2011 at 1:00 pm EDT, through June 07, 2011 until 11:59 pm EDT.  Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering account number 383 and conference ID number 372986.

About MuGard:

MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and 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 is estimated to be in excess of $1 billion world-wide.  For more information, please visit www.MuGard.com.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum in Phase 2 clinical testing of patients with ovarian cancer, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas.  

The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  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: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to 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.

SOURCE Access Pharmaceuticals, Inc.