Takeda Pharmaceuticals (TYO:4502), which is partnered with Morrisville, North Carolina-based Furiex Pharmaceuticals (NASDAQ:FURX) on the diabetes drug candidate alogliptin, has filed two new drug applications for the compound with the U.S. Food and Drug Administration. One application is for marketing approval of alogliptin and the second is for the fixed-dose combination therapy of alogliptin and pioglitazone, a diabetes drug that Takeda currently markets as Actos.
Alogliptin approval had been expected in 2009. But that year, the FDA called for new cardiovascular studies of the drug candidate based on newer cardiovascular guidance. At that time, Furiex was the drug development division of Wilmington, North Carolina clinical research organization PPD (NYSE:PPDI). PPD stood to gain a $25 million milestone payment as well as royalties upon successful commercialization of the drug. Furiex was spun out of PPD as a separate company in 2010 and Furiex now stands to gain those milestone and royalty payments if the drug becomes successful.
The potential for blockbuster status is there. Type 2 diabetes is the most common form of diabetes and it affects an estimated 25.8 million Americans, according to the American Diabetes Association. Diabetes results in more than $174 billion in annual costs, of which $116 billion is for direct medical costs.
But if the Takeda drug is the same, the market for such drugs is not. Last year, cardiovascular safety concerns regarding GlaxoSmithKline’s (NYSE:GSK) diabetes drug Avandia led to regulatory inquiries and ultimately stronger restrictions that all but barred the drug from the U.S. and European markets. GSK continues to litigate numerous Avandia lawsuits. In a post-Avandia world, regulators and clinician sensitivity to the cardiovascular risks tied to diabetes drugs remains high. That awareness will certainly factor in the regulatory process for alogliptin.
Takeda is in the midst of conducting the additional studies requested by the FDA. The company is confident that results so far support the compound’s safety.
“We believe interim results from a cardiovascular outcomes trial satisfy the FDA’s cardiovascular safety requirements to allow the agency to complete its review of our NDA, and further support the product profile of alogliptin,” Dr. David Recker, senior vice president, clinical science, Takeda Global Research & Development Center, said in a prepared statement.
Final study results are expected in 2014. Takeda’s resubmission of the applications to the FDA do not yet trigger any payments to Furiex. But Furiex currently receives milestone payments for alogliptin sales in Japan, where the drug is marketed as Nesina.