DALLAS and NEW YORK, June 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 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 the China 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.”
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 RHEI Pharmaceuticals:
RHEI Pharmaceuticals is a specialty pharmaceutical company with operations in the U.S. and in China that acquires licenses, develops and commercializes in China proprietary drug therapies based upon the unmet needs of the emerging China pharmaceuticals market. RHEI leverages its proprietary and extensive network of experienced clinical development and regulatory professionals in China to expedite approvals for pharmaceuticals new to the China market. RHEI’s growing sales and marketing capabilities then provide broad patient access in China to these new and critically necessary therapeutics. RHEI specializes in hospital-based proprietary products with a therapeutic focus on urgent unmet needs in the areas of cancer, cardiovascular disease, diabetes, neurology, and other life threatening conditions.
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.
Contact: Company | Contact: Investor Relations | |
Christine Berni | Donald C. Weinberger/Diana Bittner (media) | |
Director of Investor Relations | Wolfe Axelrod Weinberger Assoc. LLC | |
Access Pharmaceuticals, Inc. | (212) 370-4500 | |
(212) 786-6208 | ||
SOURCE Access Pharmaceuticals, Inc.
