For solid scientific reasons, FDA is giving the Taketa diabetes drug candidates program the slow-roll, per Reuters' Matthew Goldstein, a few minutes ago:
. . . .[Taketa's] Alogliptin, which belongs to a new class of diabetes drugs called DDP-4 inhibitors, has been positioned by Takeda as a successor to Actos, which will lose U.S. patent protection in 2011.
"The approval process for alogliptin by itself is separate from that of the fixed-dose combination," said Takeda spokeswoman Hisako Nagata.
"But it is difficult to think that the combination drug would receive approval prior to alogliptin by itself," she said.
There is currently only one DPP-4 diabetes drug on the U.S. market, Merck & Co's Januvia. . . .
This development is likely behind the over 3 percent increase in Merck's shares on the NYSE, this morning -- while Schering-Plough, via the coming exchange ratio, is rising about half that much, on the NYSE, this morning.
