WILMINGTON, N.C., Mar 06, 2009 (BUSINESS WIRE) -- PPD, Inc. today announced that Takeda Pharmaceutical Company Limited issued a news release reporting that the U.S. Food and Drug Administration (FDA) notified Takeda that although the alogliptin new drug application (NDA) was filed prior to issuance of the FDA’s December 2008 guidance titled “Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” the FDA will apply these guidelines when reviewing the alogliptin NDA. Takeda’s news release further reported that while the FDA does not believe the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the December 2008 guidance, the FDA is open to discussions regarding the design of additional cardiovascular studies with alogliptin. Takeda’s news release also confirmed that the Prescription Drug User Fee Act (PDUFA) date for the alogliptin NDA of June 26, 2009, remains unchanged.
As a result of this news, PPD is no longer forecasting the receipt of the $25.0 million alogliptin NDA approval milestone in 2009. PPD continues to anticipate that Takeda will submit a marketing authorization application (MAA) for alogliptin to the European Medicines Agency, or EMEA, in the third quarter of 2009. If the MAA is accepted by the EMEA, PPD will earn a $10.0 million milestone payment from Takeda. Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda’s wholly-owned U.S. subsidiary, Takeda San Diego, Inc.
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 approximately 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 contained in this news release, including expectations and assumptions relating to PPD’s financial guidance for 2009 and the prospects for regulatory approval for alogliptin in the United States or any other country, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these 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 filing acceptance or approval for alogliptin; 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; continued success in sales growth; loss of or delay in large contracts; increased cancellation rates; competition within the outsourcing industry; 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. SOURCE: PPD, Inc.
PPD, Inc. Media: Sue Ann Pentecost, 919-456-5890; sueann.pentecost@rtp.ppdi.com or Analysts/Investors: Luke Heagle, 910-558-7585; luke.heagle@wilm.ppdi.com
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