Healthcare Industry News: Oral Mucositis
News Release - December 13, 2006
Access Pharmaceuticals Receives MuGard(TM) Marketing Clearance From the FDADALLAS, Dec. 13 (HSMN NewsFeed) -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP ) announced today that it had received 510(k) clearance from the Food and Drug Administration to market MuGard(TM) in the United States.
MuGard(TM) is Access' proprietary oral rinse product for the management of Oral Mucositis, the debilitating side-effect which afflicts more than 40% of cancer patients undergoing radiation and chemotherapy. There is currently no well-accepted treatment for mucositis, and the Company believes that MuGard(TM) should be a valuable supportive care option for cancer patients. The estimated size of the market for this indication in the U.S. exceeds $1 billion. The Company is actively seeking marketing partners for this product in the U.S. and in other territories.
Rosemary Mazanet, MD, PhD, Acting CEO of Access stated, "This approval marks a major milestone for the company following the decision to focus on the development and commercialization of proprietary products for the treatment and supportive care of cancer patients. We are in active discussions for licensing and manufacturing the product and expect to have more announcements in the future."
In previously reported clinical studies MuGard(TM) prevented significant mucositis in over 40% of patients in a population where the incidence of mucositis normally exceeds 90%. In addition to the management of mucositis, the approved indication for MuGard(TM) includes all types of oral wounds, including aphthous ulcers (canker sores) and traumatic ulcers, such us those caused by oral surgery or ill-fitting dentures or braces. This broad-based approval provides the Company with the opportunity to promote the use of the product for several related oral ulcerative conditions.
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac(TM), currently in Phase II clinical testing of patients with ovarian cancer and MuGard(TM) for the treatment of patients with mucositis. The Company also has other advanced drug delivery technologies including vitamin-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, including statements relating to the size of the market for mucositis products, the effectiveness of MuGard, the Company's ability to engage a marketing partner for MuGard, the value of our products in the market, 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 the risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2005 and other reports filed by us with the Securities and Exchange Commission.
Source: Access Pharmaceuticals
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