PPD is facing yet another delay for its diabetes drug alogliptin. The Wilmington, NC-based CRO anticipated that its partner Takeda would submit the application for alogliptin to the EMEA within the next few months. Unfortunately for PPD, Takeda has decided not to seek European approval for the drug candidate just yet. The drugmaker is postponing its submission while it collects more data in a two-year trial. The comparative study will involve 2,500 patients with Type-2 diabetes and pit alogliptin against a generic combo of glipizide and metformin. Takeda decided to complete another study to ensure approval though European regulators have not asked for more data, Reuters reports.
The EMEA application is not expected to be submitted until 2012, which means PPD must do without another $10 million payment it anticipated receiving this year. Last October, PPD revealed it was out a $25 million milestone payment from Takeda due to FDA delays stemming from internal resource constraints. And again in March of this year, PPD said it would likely not receive the payment this year either, after the FDA issued new safety guidelines for diabetes treatments.
Although the FDA has said it will make a decision on alogliptin's status by the June 26 deadline set last October, the development partners have said the current amount of clinical data doesn't meet the new guidelines. Analysts expect the FDA to request more data, but a Takeda spokeswoman tells Reuters that the drugmaker is still holding out hope that the FDA will approve the drug in June. In case that doesn't happen, plans are already underway to conduct another study in the U.S., the news service reports.
All of this means it will be years before PPD sees any real payout from its investment. It's also a major setback for Takeda, which has positioned alogliptin as the successor to the diabetes med Actos, a top-seller that loses patent protection in 2011. As a DPP-4 inhibitor, alogliptin would compete with Merck's Januvia, the only DPP-4 diabetes med currently on the market.
- here's the PPD release
- and the Takeda statement
- check out the Reuters piece