Access Pharmaceuticals, Inc., a biopharmaceutical

Access Pharmaceuticals, Inc., a biopharmaceutical company, focuses on developing a range of pharmaceutical and medical device products primarily based upon nanopolymer chemistry technologies and other drug delivery technologies. Products MuGard: MuGard is a marketed product for the management of oral mucositis, a frequent side-effect of cancer therapy. MuGard, a proprietary nanopolymer formulation, has received marketing allowance in the U.S. from the U.S. Food and Drug Administration (FDA). The company launched MuGard in the United States in 2010. MuGard has also been launched in Germany, Italy, the United Kingdom, Greece and the Nordic countries by the company’s European commercial partner, SpePharm. In March 2012, the company’s partner, Rhei Pharmaceuticals HK LTtd., received regulatory and marketing approval for MuGard from the State Food and Drug Administration to treat oral mucositis in cancer patients. ProLindac: The company’s development candidate for the treatment of cancer is ProLindac, a nanopolymer DACH (Diamino Cyclohexane)-platinum prodrug. It initiated a study of ProLindac combined with Paclitaxel in second line treatment of platinum pretreated advanced ovarian cancer patients in 2010. This multi-center study of up to 25 evaluable patients is being conducted in France. A second combination study was initiated in 2011 combining ProLindac with gemcitabine for the treatment of cholangiocarcinoma. Clinical studies of other indications, including liver, colorectal, and ovarian cancer are under consideration by Jiangsu Aosaikang Pharmaceutical Co., Ltd, the company’s licensee for ProLindac in China. Thiarabine: Thiarabine, or 4-thio Ara-C, is a nucleoside analog licensed from Southern Research Institute. The company is in the process of working with leukemia and lymphoma specialists at MD Anderson Cancer Center in Houston and has initiated additional Phase 2 clinical trials in adult AML, ALL and other indications. CobOral: CobOral is the company’s proprietary preclinical nanopolymer oral drug delivery technology based on the natural vitamin B12 oral uptake mechanism. The company is in the process of developing a product for the oral delivery of insulin, and has conducted sponsored development of a product for oral delivery of peptides and RNAi therapeutics. CobaCyte: CobaCyte-mediated targeted delivery is a preclinical technology which makes use of the fact that cell surface receptors for vitamins, such as B12 are often overexpressed by certain cells including many cancers. This technology uses nanopolymer constructs to deliver more anti-cancer drug to tumors while protecting normal tissues. Patents For mucoadhesive liquid technology, two U.S. patents have issued, one European patent has been granted and one European patent application is under review. The European patent has issued in 19 European countries. Five U.S. patents and two European patents were issued and two European patent applications are pending for polymer platinum compounds. The patents and patent applications are the result in part of collaboration with The School of Pharmacy, University of London, from which the technology has been licensed and include a synthetic polymer, hydroxypropylmethacrylamide incorporating platinates, that can be used to exploit enhanced permeability and retention in tumors and control drug release. Thiarabine is subject to two process patents that expire in 2018, one use patent that expires in 2019, as well an additional patent which expires in 2027. Regulation The company is subject to regulation by the federal government, principally by the FDA, and by other federal and state agencies as well as comparable agencies in foreign countries where registration of products would be pursued. The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern the testing, manufacturing, safety, labeling, storage, shipping and record keeping of the company’s products. Competition Thiarabine’s competitors are Eli Lilly and Company, Bayer Healthcare, Cyclacel, Ltd., SciClone Pharmaceuticals and Genzyme. History Access Pharmaceuticals, Inc. was founded in 1988.