Regulatory Delay for Takeda’s Alogliptin for Diabetes

PPD, a drug development contractor said Friday it does not expects a $25 million payment from Japan-based Takeda Pharmaceuticals after that company raised concerns of a regulatory delay for the diabetes treatment candidate alogliptin.

Discovered by Takeda's wholly owned U. S. subsidiary, Takeda San Diego, Inc. the drug Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.
According to the statement by PPD the drug is to be reviewed under a new set of cardiovascular safety guidelines. It added that the Food and Drug Administration does not believe the existing study data for the drug is sufficient enough to meet certain requirements.

"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 said in a statement.

Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., which was a United States (U. S.) subsidiary, had been informed by the FDA that although the alogliptin New Drug Application NDA, was filed prior to issuance of FDA's December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA. Takeda submitted its NDA for alogliptin to the FDA in December 2007.

In December, 2008 the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". Takeda received notification in October 2008, from the FDA that it was unable to complete its review of the alogliptin NDA by the original Prescription Drug User Fee Act (PDUFA) date of October 27, 2008, due to internal resource constraints. At the time the FDA did not raise any issues with the data in the alogliptin NDA.

They received this information as a part of regular discussions about the drugs NDA that was with the FDA. The existing clinical data on alogliptin is not believed to be sufficient to meet certain statistical requirements in the new guidance.

The FDA deadline for making a decision on the drug candidate's status is June 26.

PPD stock has traded between $20.60 and $46.70 over the last 52 weeks and its shares fell $1.23, or 5.5 percent, to $21.35 in morning trading.

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