WILMINGTON, N.C.--(BUSINESS WIRE)--PPD, Inc. today announced that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda Global Research & Development Center, Inc., its wholly-owned U.S. subsidiary, has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for alogliptin.
PPD is partnering with Takeda to develop alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.
In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.
PPD announced on March 6, 2009, that the FDA had informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA guidance titled, “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA guidance.
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 38 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 about 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.
Contact:
PPD 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
