Triggers $15 million milestone payment
WILMINGTON, N.C., Feb. 28 /PRNewswire-FirstCall/ -- PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective 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 leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 30 countries and more than 10,200 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at http://www.ppdi.com.
Except for historical information, all of the statements, expectations
and assumptions contained in this news release, including expectations and
assumptions about the alogliptin NDA filing with the FDA, subsequent
milestone payments for regulatory approvals for alogliptin, if any, the
|SOURCE PPD, Inc.|
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