Affymax Inc was incorporated in Delaware in July 2001. The Company is a biopharmaceutical company in the process of restructuring operations. In March 2012, the U.S. Food and Drug Administration, or FDA, approved the Company's first and only product, OMONTYS or peginesatide Injection for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. OMONTYS is a synthetic, peptide-based erythropoiesis stimulating agent, or ESA, designed to stimulate production of red blood cells and has been the only once-monthly ESA available to the adult dialysis patient population in the U.S. In March 2013, Company implemented plans to restructure its operations in order to reduce operating costs and focus on the OMONTYS safety and other related FDA issues associated with the recall of the product. Until the product recall in February 2013, final OMONTYS drug product was manufactured as a buffered aqueous solution for intravenous or subcutaneous administration. Under its collaboration with Takeda, Company was responsible, through its contract manufacturing organizations, or CMOs, for the manufacture and supply of all quantities of OMONTYS active pharmaceutical ingredient, or API, to be used in development and commercialization around the world, and Takeda was responsible for final drug product manufacture and control. In the U.S., pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
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