Hematide, a synthetic, peptide-based erythropoiesis-stimulating agent (ESA), is designed to act on the erythropoietin receptors and stimulate the production of red blood cells by dosing once every four weeks.
Takeda and Affymax have been conducting Phase 3 program in the US and EU. Follow-up of patients in the Phase 3 program was completed in January 2010 and top-line study results are expected to be reported in the 1Q of FY 2010. An NDA submission in the US is expected later in 2010.
Nancy Joseph-Ridge, general manager of pharmaceutical development division at Takeda: said: “We are pleased that the clinical program for Hematide shows promise and that we can move to phase 3 in Japan. This milestone enables Takeda to be a step closer to providing patients with a potential new treatment option for anemia in chronic renal failure.”