FDA decision means delay in $25M payment to PPD

WILMINGTON, N.C. — Pharmaceutical Product Development (Nasdaq: PPDI) won’t receive a $25 million milestone payment this year due to a U.S. Food and Drug Administration delay in reviewing a potential diabetes drug.

PPD is developing the drug, called alogliptin, along with Takeda Global Research and Development Center.

Takeda had filled a new-drug application (NDA) with the FDA, and a response was expected by Oct. 27. The FDA said the NDA review deadline would not be met due to internal resource constraints.

Alogliptin is targeted at type 2 diabetes.