DALLAS and NEW YORK, Aug. 7, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, today announced that it had entered into an exclusive license agreement with Norgine B.V., a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in Europe. Under the terms of the license agreement, Access will receive up to $10 million in milestone payments and an escalating double digit royalty on the net sales of the oral mucositis product, MuGard, in the licensed territories. Norgine will develop, manufacture, and commercialize MuGard in the European Union, Switzerland, Norway, Iceland and Lichtenstein. Norgine anticipates launching MuGard in 2015.
Commenting on the news, Jeffrey Davis, CEO of Access Pharmaceuticals, Inc stated, "Access is excited to announce this partnership with Norgine, a leading European specialty company, as it further validates our global MuGard commercial strategy." He added, "With product offerings in complementary therapeutic areas and an established presence in the cancer supportive care space, Norgine is an ideal partner for us and we believe this partnership will drive commercial adoption in Europe and facilitate access of a proven treatment option to help protect patients from oral mucositis, a debilitating side effect."
"This new partnership with Access Pharmaceuticals Inc. represents an excellent opportunity to ensure that cancer patients affected by oral mucositis can access MuGard, to help manage this condition for which there are limited effective treatment options," said Peter Stein, CEO of Norgine. He continued, "This collaboration is further evidence of Norgine's commitment to acquire specialty pharmaceutical products to strengthen its portfolio."
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 received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is also licensed in China, RHEI/Jian An, and in Korea with Hamni Pharmaceuticals.
Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine's total revenue was €274 million and the company employs over 1,000 people.
Norgine's focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology , critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France. In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US.
For more information, please visit www.norgine.com
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, and ProLindac™, a second generation DACH platinum drug. 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 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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