PPD confirms Japanese approval for Takeda's NESINA NDA

PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited's new drug application for NESINA^® (alogliptin), a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare on April 16. PPD's compound partnering division collaborated with Takeda to develop this product.

“This approval is an important milestone and confirms our strategy of partnering with pharmaceutical companies such as Takeda to bring new therapies to market.”

Under PPD's agreement with Takeda, PPD is entitled to a $7.5 million milestone payment from Takeda upon approval of all regulatory and pricing matters in Japan. The approval of the NDA for NESINA noted above constitutes the regulatory approval required for the milestone payment. Upon pricing approval for NESINA in Japan, PPD will be entitled to receive the milestone payment.

"We are pleased that Takeda has received NDA approval for NESINA in Japan," said Fred Eshelman, executive chairman of PPD. "This approval is an important milestone and confirms our strategy of partnering with pharmaceutical companies such as Takeda to bring new therapies to market."

As previously announced, PPD expects to complete the spin-off of its compound partnering business as Furiex Pharmaceuticals, Inc., by mid-2010. Furiex Pharmaceuticals will operate as an independent, publicly traded company.

Source PPD