Takeda's alogliptin submission to European regulators delayed til 2012

Japanese drug major Takeda has notified the European Medicines Agency (EMEA) that it will postpone its marketing authorization applications  for alogliptin (SYR-322) and alogliptin/pioglitazone (SYR-322-4833),  originally planned for mid-2009, as it is initiating a long-term trial  for the type 2 diabetes drugs. The two-year study will test the efficacy  and safety of alogliptin compared to glipizide when used in combination  with metformin in subjects with type 2 diabetes, whose blood sugar level  is inadequately controlled with metformin. Due to Takeda's decision to  postpone its submissions, the firm's US partner PPD is no longer  forecasting the receipt of a $10.0-million MAA acceptance milestone  this year. Takeda's target timing for the submissions is now 2012. The  compound is a dipeptidyl peptidase-4 inhibitor. The firm bought the  rights to the agent from PPD for an upfront fee of $15.0 million in  2005.