DALLAS and NANJING, PRC, June 4 /PRNewswire-FirstCall/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP) and Jiangsu Aosaikang Pharmaceutical Co., LTD. ("ASK"), a premier pharmaceutical company focused on bringing oncology medicines to the China market, today announced the signing of a definitive licensing agreement under which ASK will manufacture, develop and commercialize Access' proprietary product ProLindac(TM) for the Greater China Region which includes the People's Republic of China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and Taiwan. 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.
Under the terms of the agreement ASK will pay Access an upfront fee and subsequent milestone payments along with a double digit royalty upon commercialization of ProLindac. In addition, in co-operation with Access, ASK has committed to fund and execute two (2) Phase 2 studies for ProLindac in colorectal cancer and one other indication to be determined by the Parties. These major Phase 2 studies would cost up to $20 million if conducted in the US or Europe. ASK has also committed to become a second source for the manufacturing of ProLindac. ASK will be responsible for obtaining the necessary regulatory approvals for ProLindac and commercializing the product in the Greater China Region.
"We are very pleased to have ASK, a leading supplier of platinum based agents in China, as our first partner for ProLindac," said Jeffrey B. Davis, Access' President & CEO. "ASK is the second largest supplier of platinum based oncology agents in China and has a long history of successfully manufacturing and commercializing agents similar to ProLindac. They will be a valuable second source for the manufacturing of ProLindac and their commitment to fund two Phase 2 studies will save us up to $20 million in clinical trial funding we would otherwise have to raise from the equity markets. With the recently announced positive results from the ongoing clinical study plus this commitment from ASK, we believe we are well positioned to quickly advance the development of ProLindac."
"ProLindac is a synergistic product to our current product portfolio, and represents a significant innovation in the area of platinum-based cytotoxic agents," added Qingcai Chen, PhD, President and Chairman of ASK. "We are excited about the potential for ProLindac in China, and we are committed to bringing exciting, innovative new oncology products like ProLindac to the rapidly emerging China market. We look forward to a long and productive relationship with Access over the long term."
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.
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 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 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.