A new type 2 diabetes drug developed by Japan’s largest pharmaceutical company in partnership PPD has been approved by Japan’s Ministry of Health, Labour and Welfare. The approval of a new drug application for NESINA (alogliptin) came on April 16.

Under PPD’s agreement with Takeda, the Wilmington-based company is entitled to a $7.5 million milestone payment from Takeda since the drug received regulatory approval.

“This approval is an important milestone and confirms our strategy of partnering with pharmaceutical companies such as Takeda to bring new therapies to market,” said Fred Eshelman, executive chairman of PPD in a press release.

PPD expects to complete the spin-off of its compound partnering division, which partnered with Takeda to develop this drug. The spin-off will be complete by mid-2010 and Furiex Pharmaceuticals, Inc. will operate as an independent, publicly traded company based out of Morrisville.

In October 2008, the U.S. Food and Drug Administration (FDA) announced it would not complete its review of Takeda's new drug application (NDA) for alogliptin by the Prescription Drug User Fee Act (PDUFA) date because of insufficient FDA resources. The FDA subsequently set a new PDUFA date in second quarter 2009, according to an email from a PPD spokesperson. In addition to the U.S. regulatory review, Takeda submitted an NDA for alogliptin to Japan's Ministry of Health, Labour and Welfare in September 2008, triggering a milestone payment to PPD.

If approved, alogliptin will be one of a new class of drugs for the treatment of type 2 diabetes. PPD's collaboration with Takeda to develop alogliptin demonstrates the effectiveness of PPD's compound partnering program in accelerating the drug development process. PPD took the compound from lead optimization to NDA submission in a total of 49 months, trouncing traditional development timelines. If approved and marketed, PPD will be entitled to receive milestone payments and royalties on drug sales, according to the email.