DARA Biosciences Inc

DARA Biosciences Inc was incorporated on June 22, 2002. It is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care pharmaceutical products. Through its acquisition of Oncogenerix, Inc., which occurred on January 17, 2012, the Company acquired exclusive U.S. marketing rights to its first commercial proprietary product, Soltamox (oral liquid tamoxifen). The Company's main focus is on the development and commercialization of oncology treatment and supportive care pharmaceutical products: Soltamox, Gemcitabine and other generic sterile injectable cytotoxic products, and Cancer support therapeutics. Soltamox (oral liquid tamoxifen), its first proprietary, FDA approved product, is a drug primarily used to treat breast cancer. Soltamox has been approved by the U.S. Food and Drug Administration ('FDA') for the treatment of breast cancer. Soltamox will be the only liquid formulation of tamoxifen available for sale in the United States. Soltamox is used mainly for the chronic treatment of breast cancer or for cancer prevention in certain susceptible breast cancer subgroups. The Company is also focusing on the development and commercialization of generic sterile injectable cytotoxic products. The Company's agreement with Uman Pharma Inc. pursuant to which it received an exclusive license to import, sell, market and distribute Uman's gemcitabine lyophilized powder product in 200mg and 1g dosage sizes in the U.S. Gemcitabine went off patent in 2011 in the U.S. and is prescribed as first-line therapy for ovarian, breast, lung and pancreatic cancers. Currently, the Company has two main drug candidates advancing through clinical development with cleared Investigational New Drug applications from the FDA: KRN5500, a novel, non-narcotic/non-opioid for the treatment of neuropathic pain in patients with cancer; and DB959, a first-in-class drug candidate for the treatment of type 2 diabetes and dyslipidemia. The Company mainly competes with other pharmaceutical companies, biotechnology companies and other research and academic institutions. The Company's advertising, marketing and distribution of pharmaceutical products in the United States is subject to the regulation of United States Food, Drug and Cosmetic Act.