Access Pharmaceuticals Receives Letter of Acceptance For MuGard Filing From SFDA of China

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 its MuGard partner in China, RHEI Pharmaceuticals has received the acceptance letter from the State Food and Drug Administration (SFDA) of China acknowledging all necessary documentation for the MuGard has been submitted and accepted. Together with its marketing partner Jian An, RHEI Pharmaceuticals completed the required process required to satisfy all requirements to receive marketing approval in China and its other South East Asian territories. RHEI has advised Access of the next steps the SFDA will take to grant approval in its territories and anticipates receiving marketing approval in the second half of this year.As part of its licensing agreement with Access, RHEI is responsible for obtaining the necessary regulatory approvals for MuGard. Access and RHEI recently signed a $30 million supply agreement for MuGard to ensure manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. In addition, Access also approved a sub-license agreement between RHEI Pharmaceuticals and Jian An Pharmaceuticals ("Jian An") Limited in Shenzhen, China to leverage Jian An's extensive sales, marketing and regulatory infrastructure for the launch of MuGard in China and Taiwan. Jian An is headquartered in Shenzhen, China and has a 25-year history of selling pharmaceutical and other medical products in theChina market. Jian An has 1400 sales representatives covering all majors centers in China through 169 sales offices. With Jian An's sales and marketing infrastructure, the supply agreement and the letter of acceptance, Access Pharmaceuticals' commercialization efforts remain on track in China. Access retains its existing milestone and royalty structure for the territory. "The acceptance of MuGard submission is a critical step in receiving marketing approval for MuGard in China and South East Asian territories," said Phillip Wise, Vice President of Business Development and Strategy, Access Pharmaceuticals, Inc. He continued, "We knew that the SFDA would perform a significant amount of due diligence before it would accept our MuGard submission. Receiving the acceptance letter helps us, as a company, gauge more accurately the timeline to marketing approval. We are pleased with RHEI and Jian An's ability to streamline the process thus far and their continued progress and commitment to advancing the marketing approval."

Access Pharmaceuticals Appoints Industry Executive Anthony Mottola as Vice President of Managed Care and Market Access

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes,has named Anthony Mottola as its Vice President of Managed Care and Market Access. A 16-year industry veteran, Mottola brings to Access an extensive pharmaceutical industry knowledge and experience in specialty pharmacy, healthcare services and reimbursement solutions. Anthony will lead the overall management of reimbursement and market access for MuGard within Access Pharmaceuticals.

Prior to joining Access, Anthony served as VP of Trade for BioScrip, where he developed customized distribution strategies, patient access and reimbursement programs to support the successful launch of various products, including MuGard. He was previously Associate Director National Accounts for Novartis, where he was responsible for the management and development of multiple national accounts, including Specialty Pharmacies, Reimbursement HUB Providers, Specialty distributors, GPO's, Managed Care Plans such as Cigna, Humana, Wellpoint and Government Organizations. Prior to Novartis, Anthony served in different capacities of sales management, mainly in the oncology area, at Pfizer, US Bioservices and Abbott Laboratories.

Anthony Mottola, Vice President Managed Care and Market Access, Access Pharmaceuticals, stated, "While working with Access at BioScrip, it became clear that MuGard was a superb product in a market relatively untapped by its competitors. I was encouraged to join Access by the enthusiastic patient and clinician support surrounding MuGard and its strong potential to become a market leader. I look forward to leveraging my experience and relationships to further strengthen Access' sound patient access program for MuGard."

"This appointment is an important step of our MuGard launch in the US," said Jeffrey Davis, CEO of Access Pharmaceuticals, Inc. He continued, "Anthony's hands-on development and reimbursement solutions expertise will be central to our efforts to further build out the necessary infrastructure and capability for the continued growth of our MuGard division."

Access Pharmaceuticals Signs eMarketing Agreement With iMedicor For MuGard(TM)

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced today that it had signed an agreement with iMedicor (OTC Bulletin Board: VMCI) for the North American commercial launch of MuGard, its FDA approved mucoadhesive oral rinse for the management of oral mucositis and stomatitis caused by radiotherapy and/or chemotherapy. Using iMedicor's highly targeted Alerts System application, initial introduction of MuGard to the 216,000 selected physicians in the US is expected to begin by the end of the year. MuGard is being commercially launched worldwide, with initial launches in the United Kingdom, Germany, Italy, Norway and Greece having been previously announced. Access expects additional commercial launches in Europe, and in the Far East through two partners to start shortly.

"We look forward to working with Access Pharma to help them introduce MuGard in a cost effective, non-intrusive manner, a potential blockbuster product which could significantly improve the quality of life for patients undergoing certain cancer treatments," said Fred Zolla, CEO of Vemics iMedicor. "Using our Alert System, iMedicor's ability to deliver essential information from a trusted source to specific physician audiences will significantly increase our client's marketing ROI."

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.

"We are excited about iMedicor's ability to introduce MuGard more rapidly and to a broad physician audience than we would expect through traditional distribution channels," said Access' CEO Jeffrey Davis. "We believe through this new marketing partnership with iMedicor, Access will be able to reach a broad spectrum of oncologists, radiation oncologists and other key clinicians in a very cost-effective manner, to utilize the medical education aspects of the system to educate about oral mucositis and MuGard, and to accelerate commercial uptake in the US market."

Access Pharmaceuticals Signs Agreement to Manufacture Its FDA-Approved MuGard in the United States

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 Provides Update on Global Launch of MuGard(TM)

NEW FDA-APPROVED TREATMENT FOR ORAL MUCOSITIS

DALLAS, - ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), announced today that MuGard(TM), its proprietary oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care. The Company has previously announced commercialization agreements in North America, China and eight Southeast Asian countries and Korea, and is actively seeking additional marketing partners in other regions; MuGard expects commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement gets established regionally.

MuGard is a 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 radiation therapy 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.

"Access is pleased with the commercial launch of MuGard in Europe, and the progress made by our partners in other regions of the world," said Phillip Wise, Vice President of Business Development at Access. "Access is also working with its partners outside of Europe to establish GMP manufacturing and secure necessary approvals and/or reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option," he continued.

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 Presents New Data on ProLindac(TM) at the 2009 AACR Annual Meeting

DALLAS, ACCESS PHARMACEUTICALS, INC. (OTC:ACCP) (BULLETIN BOARD: ACCP) announced today that its collaborators at Centre Rene Huguenin in France presented new preclinical data on its lead anticancer compound, ProLindac(TM), at the American Association for Cancer Research (AACR) Annual Meeting taking place April 18-22, 2009 at the Colorado Convention Center in Denver. The poster presentation entitled "DACH platinum (dach-Pt) release kinetics, ex-vivo and in vivo plasma protein binding and evaluation of red blood cell (RBC) partitioning of ProLindac, a novel DACH-Pt-bound biopolymer" was presented on Monday, April 20.

 

ProLindac is Access' novel polymer-based DACH platinum prodrug which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. Access recently announced positive results from the completed phase 2 monotherapy clinical study in recurrent ovarian cancer. The study reported in the 2009 AACR poster provides in vitro and ex-vivo data on the binding of ProLindac to blood components, and suggests a mechanistic rationale for ProLindac's favorable efficacy and safety profile.

 

"The data shows that ProLindac's polymer carrier is highly bound to circulating plasma proteins," stated David P. Nowotnik, Ph.D., Access' Senior Vice President, Research and Development. "As a result, we would expect ProLindac to provide sustained tumor exposure to platinum. In addition, there was little red blood cell accumulation, which could account for the lower level of hematological toxicities observed for ProLindac compared to others platinum species."

 

"We are grateful to our European collaborators for their ongoing studies, which continue to expand our knowledge and understanding of the unique characteristics of our proprietary platinum prodrug," commented Jeffrey B. Davis, Access' President & CEO. "Following the recent announcement of positive results from the completed phase 2 clinical study in patients with recurrent ovarian cancer, and from in vitro data reported previously showing that the anticancer properties of ProLindac are enhanced when used in combination with other anticancer drugs, Access is manufacturing additional supplies of ProLindac for planned combination studies later this year."

 

Access currently has two development and commercialization partners for ProLindac. A licensing agreement with Jiangsu Aosaikang Pharmaceutical Co., Ltd. ("ASK") was signed in 2008 under which ASK will manufacture, develop and commercialize ProLindac for the Greater China Region which includes the People's Republic of China. In February 2009, Access announced it had signed a licensing agreement with JCOM, Ltd for South Korea for both ProLindac and MuGard, its FDA approved therapy for oral mucositis. Under these licensing agreements, Access receives milestone payments and royalties on sales. Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories.