Type 2 diabetes drug alogliptin may have fallen short of regulatory approval in the United States, but its latest progress overseas is paying off for Furiex Pharmaceuticals (Nasdaq: FURX) in the form of a $10 million milestone payment.
The marketing authorization application filed by drug partner Takeda Pharmaceutical was accepted, triggering the payment to Furiex.
If the drug ultimately receives European approval, Morrisville-based Furiex stands to gain another $10 million milestone and it will also collect royalties on alogliptin sales. Alogliptin was approved in Japan in 2010. Furiex draws royalties on alogliptin sales in Japan, where the drug is marketed under the names Nesina and Liovel.
Furiex stands to gain a $25 million milestone payment if alogliptin is approved in the United States. But the drug candidate fell short of approval in April, receiving a complete response letter from the U.S. Food and Drug Administration. It was the third complete response letter for the compound. For the two CRLs issued in 2009, the FDA requested more cardiovascular data.
Takeda disclosed few details about the latest CRL for alogliptin but acknowledged that regulators asked for more information that Takeda said it would be able to provide from postmarketing studies and ongoing clinical research. Takeda is currently conducting a cardiovascular outcomes study. Final results aren’t expected until 2014.
Furiex’s partnership with Takeda dates to 2005 when Furiex was the drug development arm of Wilmington-basedclinical research organization PPD.
PPD spun out Furiex as a standalone company in 2010.