Rochester,NY 6/30/2009 1:32:42 AM
PPDI - PPD Confirms Takeda Receives FDA Complete Response for Alogliptin
Pharmaceutical Product Development Inc
Afternoon Movers - PPDI - PPD Confirms Takeda Receives FDA Complete Response for Alogliptin - Sourced WhisperFromWallStreet.com
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Pharmaceutical Product Development Inc.PPDI
After Hours: 23.31 Down 0.01 (0.04%) 2:26PM ET
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.
About
Pharmaceutical Product Development, Inc. (PPD), a contract research organization, provides drug discovery and development services, post-approval expertise, and compound partnering programs. The company operates in two segments: Discovery Sciences and Development. The Discovery Sciences segment offers various preclinical services, including preclinical program design, preclinical oncology research models, toxicology consulting, laboratory services, and technical writing and regulatory submissions; biomarker discovery and patient sample analysis; and compound collaboration programs. The Development segment provides a range of development services, including strategic product development solutions; Phase I clinical testing; laboratory services, such as testing services with customized results databases for pharmaceutical and biotechnology companies engaged in clinical drug development, as well as government-funded studies; and Phases II-IV clinical trial management services primarily comprising study protocol and case report form design, site and investigator recruitment, patient enrollment and study feasibility, interactive voice and/or Web response systems, investigative product services, study monitoring and data collection, government services, data management and biostatistical analysis, medical writing and regulatory services, and post-approval services.
Last Trade: 23.29
Day's Range: 22.65 - 23.37
52wk Range: 17.97 - 45.72
Volume: 369,987
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