Access Pharmaceuticals Announces MuGard License Agreement With Hanmi Pharmaceutical In Korea
NEW YORK, March 11, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) today announced that it had entered into an exclusive license agreement with HANMI PHARMACEUTICAL CO., LTD. (KSE: 128940) related to MuGard commercialization in South Korea. Under the terms of the license agreement, Access will receive an upfront licensing fee and double digit royalties on net sales of MuGard in the licensed territory. MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients in the US alone developing the condition each year.
"Access is pleased to announce this partnership with Hanmi Pharmaceuticals, a leader in Korea, as we believe that international expansion and licensing is critical to the commercial success of MuGard," said Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Hanmi's international presence, resources and strategic emphasis on expansion makes them an ideal partner for MuGard. With the recent publication of MuGard clinical data, completion of this third marketing partnership, and active discussions with additional partnerships abroad, Access is laying the foundation for MuGard growth globally."
Access recently announced publication of positive MuGard clinical data in Cancer, the journal of the American Cancer Society. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available at http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.
About Hanmi: Established in 1973, Hanmi Pharmaceutical dedicates over 15% of its annual revenue into research and development on novel drug discovery and incrementally modified drugs. Hanmi transferred its technology to Roche and Novartis in what was Korea's first and largest scale in drug technology export. Hanmi further raised its global profile and recognition as the pharmaceutical leader of South Korea following its export license and agreement with Merck on Hanmi's fixed dose hypertension drug Amosartan. Beginning with the establishment of Beijing Hanmi Pharmaceutical Co., Ltd in domestic China, Hanmi is expanding its global presence into major markets such as Japan, Europe and USA. For more information, please visit http://www.hanmipharm.com/eng/.
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 developed MuGard and is developing multiple follow-on products. Access 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 timeliness and clinical results for MuGard and Cobalamin, 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.
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