Transaction Value in Excess of $10 Million; Access Gains Second
Source Manufacturing and Significant Clinical Trial Support
DALLAS, and SEOUL, South Korea, Feb. 19 /PRNewswire-FirstCall/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP) and JCOM Ltd, an affiliate of DONG-A Pharmaceuticals, the premier pharmaceutical company in the Republic of Korea, today announced the signing of a definitive licensing agreement under which JCOM and DONG-A will manufacture, develop and commercialize Access' proprietary products ProLindac and MuGard for the Republic of Korea. ProLindac is Access' novel DACH platinum prodrug currently in Phase 2 clinical studies which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. 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 US and European regulatory authorities.
Under the terms of the agreement JCOM will pay Access an upfront fee and subsequent milestone payments along with a double digit royalty upon commercialization of ProLindac and MuGard. In addition, in co-operation with Access, JCOM has committed to fund and execute a Phase 2 combination study for ProLindac in an indication to be determined by the Parties. This controlled Phase 2 combination study would cost up to $10 million if conducted in the US or Europe. Dong-A will be responsible for obtaining the necessary regulatory approvals for ProLindac and MuGard and commercializing the products in the Republic of Korea.
"We are very pleased to have JCOM and Dong-A as partners for ProLindac and MuGard," said Jeffrey B. Davis, Access' President & CEO. "We are excited about their commitment to rapidly start a Phase 2 study with ProLindac. This is the third major Phase 2 study to be funded by our external partners for ProLindac and will allow us to build a robust data package in a number of potential indications far beyond what we could generate on our own." Mr. Davis continued, "We are also extremely excited about having one of the largest Pharma companies in Korea promoting our MuGard product."
ProLindac is a novel DACH platinum prodrug which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. Access believes that ProLindac's unique molecular design potentially could eliminate some of the toxic side effects seen in the currently marketed DACH platinum, Eloxatin, which has sales in excess of $2 billion. Access recently presented data from the ongoing Phase 2 monotherapy clinical study of ProLindac in patients with recurrent ovarian cancer. In two dosing regimens, ProLindac was given once every two weeks and once every three weeks. During the last and highest dose levels explored, sustained and significant reductions in the specific serum market Ca-125 were seen over multiple dosings in several patients. ProLindac was well-tolerated with minimal side-effects.
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.
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. 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 ability to close the financing transaction, early results from our clinical trial, Access' plans to continue and initiate clinical trials, the value of its 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.
|SOURCE Access Pharmaceuticals, Inc.|
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