FDA To Continue Review Of Alogliptin NDA - New Treatment Option For Diabetes Type 2 Patients

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 13 Oct 2008 - 3:00 PST

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PPD, Inc. (Nasdaq: PPDI) today announced that Takeda Pharmaceutical Company Limited reported that Takeda Global Research and Development Center, Inc., a wholly owned U.S. subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin new drug application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

In the news release, Takeda stated that in its most recent discussion with the FDA, the agency indicated that due to internal resource constraints it would not be able to complete the alogliptin review by the PDUFA date. Although Takeda said the FDA did not provide any guidance on when a review might be completed, Takeda indicated that it remains confident in alogliptin's potential as a new treatment option for people suffering from type 2 diabetes and reiterated that it will work with the FDA as the agency continues this NDA review.

As a result of this notification, PPD does not anticipate the FDA will complete its review of the alogliptin NDA by the end of 2008. Thus, PPD does not expect to receive the $25.0 million alogliptin NDA approval milestone in the fourth quarter of 2008.

Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda's wholly owned U.S. subsidiary, Takeda San Diego, Inc. In December 2007, Takeda submitted its NDA for alogliptin for the treatment of type 2 diabetes.

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 33 countries and more than 10,500 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, including expectations and assumptions about the approval of the alogliptin NDA, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making those forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause results to differ materially include the following: risks associated with the development and commercialization of drugs, including obtaining regulatory approvals; risks associated with and dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; economic conditions and outsourcing trends in the pharmaceutical, biotechnology and medical device industries and government-sponsored research sector; loss of or delay in large contracts; risks associated with acquisitions and investments, such as impairments; competition within the outsourcing industry; success in sales growth; the ability to attract and retain key personnel; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.