PPD, Inc. confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a DPP-4 inhibitor for the treatment of type 2 diabetes, has been accepted for filing by the U.S. Food and Drug Administration. PPD partnered with Takeda to develop the compound.
Under PPD's agreement with Takeda, the FDA's acceptance of the NDA filing triggers a $15 million milestone payment to PPD. This milestone payment was included in PPD's previously issued 2008 financial guidance.
"We are pleased to partner with Takeda, one of the leading pharmaceutical companies in the area of diabetes," said Fred Eshelman, PPD's chief executive officer. "We are also delighted that this important regulatory milestone has been achieved as a result of close cooperation between Takeda and our company."
PPD is a global contract research organization providing discovery, development, and post-approval services as well as compound partnering programs.
Release date: February 28, 2008
Source: PPD, Inc.