Access Pharmaceuticals Receives Final Marketing Approval From SFDA of China for MuGard

DALLAS and NEW YORK, Feb. 24, 2012 /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 its MuGard partner in China, Rhei Pharmaceuticals HK Ltd., received regulatory and marketing approval for MuGard in China from the State Food and Drug Administration, or SFDA, to treat oral mucositis in cancer patients.  Manufacturing of MuGard will commence shortly in the United States to meet the demand created by Jian An, Rhei's sales and marketing partner in China.

Last year, Access and RHEI 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 the China market.  Jian An has 1400 sales representatives covering all majors centers in China through 169 sales offices. 

Expressing enthusiasm on the approval, Jeffrey B. Davis, President and Chief Executive Officer of Access Pharmaceuticals, Inc. stated, "Receiving final marketing approval from the SFDA of China is a transformative milestone for our global MuGard program.  China represents a key target market with its large and increasingly affluent population and its desire for improved oncology care.  With the approval process now complete, we look forward to moving as quickly as we can to complete manufacturing so Rhei and Jian An can launch MuGard through their well established sales and marketing infrastructure in China."

"China is one of the fastest growing oncology markets and cancer supportive care has been improving throughout recent years," said Sven De Backer, Chief Executive Officer, Rhei Pharmaceuticals HK Ltd..  He continued, "Rhei and Jian An are proud to bring MuGard to patients and physicians as we believe it is a critical and valuable product that addresses a significant unmet need for a large and growing patient population."

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, characterized by inflammation and erythema or ulcerations throughout the oral mucosa.  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.

About RHEI Pharmaceuticals:
Rhei Pharmaceuticals HK Ltd. (RHEI) is a global pharmaceutical business development firm, with special focus on bringing core medicines from the U.S., Europe and Japan into the fast-growing South-East Asian marketplace. They are experts in business development, regulatory approval and clinical development and have a management team that combines a Western approach to pharmaceuticals with a long experience in Europe, North America and South-East Asia. They use their development capabilities and network of preferred commercial partners to help other pharmaceutical companies introduce their products into specific niche markets, such as the European institutional health care market and the Chinese hospital market. RHEI is headquartered in Hong Kong and has operations in Europe, the USA and China. www.rheipharma.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.