DALLAS, Aug. 18 /PRNewswire-FirstCall/ — ACCESS PHARMACEUTICALS, INC. (BULLETIN BOARD: ACCP) and Milestone Biosciences, LLC (“Milestone”) today announced the signing of a definitive license agreement under which Milestone will market Access’ proprietary product MuGard(TM) in the United States and Canada. Milestone is a company recently started by former executives and sales representatives of companies with an established commercial presence in oncology, including MGI Pharma, Amgen and Genentech. MuGard is used for the management of oral mucositis, a debilitating side effect of many anticancer chemotherapy and radiation treatments, and has already received marketing allowance from the U.S. Food and Drug Administration. Under the terms of the agreement, Milestone will pay Access upfront license fees and subsequent milestone payments that total $10 million along with a double digit royalty upon commercialization of MuGard. Milestone expects to launch MuGard in the US early in the first quarter of 2009.
“We are pleased to have Milestone as our North American partner for MuGard,” said Jeffrey B. Davis, President & CEO of Access. “Milestone has assembled a team of very experienced pharmaceutical executives with a great track record of commercial success in oncology supportive care, including experience with the oral mucositis market and related chronic dry mouth market. We are excited and confident that this team of experienced executives will successfully launch and commercialize MuGard.”
“MuGard is an important product for Milestone as it gives us a tremendous near term product around which to launch and further grow our sales team. We believe there is a significant un-met medical need for MuGard with solid commercial sales potential,” stated Eric Loukas, CEO of Milestone. “Our seasoned commercial team is excited about the potential for MuGard in the oral mucositis marketplace. We look forward to a long and productive relationship with Access with MuGard, and the potential opportunity to work with them on other products as well.”
About MuGard(TM): 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 comparison of cancer patients receiving standard mucositis care with those patients using 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 Milestone: Milestone Biosciences, LLC is a privately held specialty biotech company with offices in Florida, Minnesota and New Jersey, that focuses on in-licensing and commercializing niche oncology products that would otherwise have limited exposure in the oncology marketplace. Milestone is dedicated to making these products available to patients whose treatment options are limited, or where there are recognized unmet medical needs.
About Access: 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 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, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix(R), a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; Prodrax(R), a non-toxic prodrug which is activated in the hypoxic zones of solid tumors to kill cancer cells; Alchemix, a chemotherapeutic agent that combines multiple modes of action to overcome drug resistance. Access is also developing Phenylbutyrate (“PB”), an HDAC inhibitor and differentiating agent currently a Phase 2 clinical candidate. 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: our ability to achieve milestone payments relating to MuGard, the timing of the expected launch of MuGard, the value of our products in the market, its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited 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.
Access Pharmaceuticals, Inc.
CONTACT: Media, Stephen B. Thompson, Vice President, Chief FinancialOfficer of Access Pharmaceuticals, Inc., +1-214-905-5100; or InvestorRelations, Donald C. Weinberger or Alisa Steinberg, both of Wolfe AxelrodWeinberger Assoc. LLC, +1-212-370-4500, for Access Pharmaceuticals, Inc.; orFrank Jacobucci, President and COO of Milestone Biosciences, LLC,+1-609-330-4949
Web site: http://www.accesspharma.com/
Comments