Takeda Receives FDA Complete Response Letter for the InvestigationalFixed-Dose Combination of alogliptin and ACTOS® (pioglitazone HCl) for the Treatment of Type 2 Diabetes

DEERFIELD, Ill., and OSAKA, Japan, September 4, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS® (pioglitazone HCl). The FDA informed Takeda on June 26, 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular (CV) safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.”