DALLAS and NEW HAVEN, Conn., Jan. 14 /PRNewswire-FirstCall/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP) and RHEI Pharmaceuticals, Inc. ("RHEI"), a specialty pharmaceutical company focused on bringing proprietary medicines to the China market, today announced the signing of a definitive licensing agreement under which RHEI, which has more than 110 national sales representatives penetrating large volume hospitals, will market Access's proprietary product MuGard(TM) in the Peoples Republic of China and certain other Southeast Asian countries. MuGard(TM) has received marketing allowance from the U.S. Food and Drug Administration for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Oral mucositis has become a significant unmet medical need as a result of improved medical care in China and the Southeast Asian region. RHEI will be responsible for marketing MuGard in the People's Republic of China, Hong Kong, Macau, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam, as well as for manufacturing and for obtaining the necessary regulatory approvals for the product in the territory.
"We are pleased to have MuGard in our portfolio of products in China, building on our expertise in the area of oncology," said Dr. X. Sylvia He, Chief Executive Officer of RHEI. "Our mission is to bring innovative products to the Chinese market and MuGard fulfills a real medical need. With an increasing number of patients receiving radiation and chemotherapy in China, the prevalence of oral mucositis is growing. Our expert capabilities in sales and marketing, manufacturing and regulatory will help to maximize MuGard's potential in the marketplace."
"RHEI is a great partner for us in China," added Jeffrey B. Davis, Chief Executive Officer of Access. "We are excited about the potential for MuGard in China and believe RHEI is uniquely positioned to commercialize MuGard in this region. We believe MuGard will fit very well with their existing portfolio of products and benefit from their aggressive marketing programs. We are also excited about the efficiency RHEI will obtain by manufacturing MuGard in their own GMP facility."
MuGard is a ready-to-use mucoadhesive oral wound rinse. The mucoadhesive formulation forms a protective coating over the oral mucosa when washed around the mouth. In a retrospective 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. Up to 40% of all patients receiving chemotherapy and/or 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 worldwide.
About RHEI Pharmaceuticals:
RHEI Pharmaceuticals is a venture backed 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.
Access Pharmaceuticals, Inc. is a biotechnology company that leverages its proprietary nano-polymer chemistry expertise to develop proprietary products. Access' products include ProLindac(TM), a novel DACH platinum drug that is 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. For additional information on Access Pharmaceuticals, please visit our website at http://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: Access' plans to initiate clinical trials, the value of our products in the market (including MuGard and the size of the overall market for mucositis products), our ability to achieve clinical and commercial success, our ability to successfully develop marketed products and the ability to obtain or meet the closing conditions in the merger agreement with Somanta Pharmaceuticals, Inc. and applicable regulatory and tax requirements, and to otherwise complete the merger in a timely manner. These statements are subject to numerous risks, including but not limited Access' need to obtain additional financing and to the risks detailed in Access' Annual Report on Form 10-KSB and other reports filed by Access with the Securities and Exchange Commission.
|SOURCE Access Pharmaceuticals, Inc.; RHEI Pharmaceuticals, Inc.|
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