Press Releases
February 18, 2010
Takeda Pharmaceutical Company Limited
HEMATIDE™ ENTERED INTO THE PHASE 3 CLINICAL PROGRAM
TO TREAT ANEMIA IN CHRONIC RENAL FAILURE PATIENTS IN JAPAN
Osaka, Japan (Feb-18) Takeda Pharmaceutical Company Limited “Takeda” today announced that the investigational compound, Hematide™, of which Takeda and Affymax Inc (Palo Alto, Calif) “Affymax” contracted the global license agreement, for the treatment of anemia in chronic renal failure has entered into phase 3 clinical program in Japan.
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.
"We are pleased that the clinical program for Hematide™ shows promise and that we can move to phase 3 in Japan,” said, Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division of Takeda. “This milestone enables Takeda to be a step closer to providing patients with a potential new treatment option for anemia in chronic renal failure."
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 U.S. is expected later in 2010.
| Subjects | Patients with anemia in chronic renal failure |
| Study Design | Randomized comparative studies 1) A multicenter study to evaluate efficacy and safety of Hematide in chronic renal failure patients not on dialysis and not on ESA treatment compared with rHuEPO agent 2) A multicenter study to evaluate efficacy and safety of Hematide in chronic renal failure patients on hemodialysis and on ESA treatment compared with rHuEPO agent |
| Number of Patients | About 350 |
| Duration of Administration | 24 weeks (Once every four weeks) |
| Study Site | Japan |
| Primary Endpoint | The mean change in hemoglobin |