Japan´s biggest drugmaker Takeda Pharmaceutical Co has stated the U.S. health authorities´ review on their experimental diabetes drug alogliptin or SYR-322, scheduled to finish on October 27th and critical to Takeda as their main replacement for best-selling Actos, is not on schedule due to a lack of resources.

Diabetes drug Actos, with sales in Japan´s first quarter 2008 of $ 958 million dollars (yearly sales of some $ 3 billion dollars, almost 30 percent of Takeda´s income) will lose U.S. patent protection in 2011.

The U.S. Food and Drug Administration (FDA) did not ask for more information on alogliptin, raise any issues with data or provide any guidance on when a review – submitted on January 4th, 2008 - might be completed, a Takeda spokeswoman said.

Last month, the FDA also failed to complete a review of Eli Lilly & Co and Daiichi Sankyo Co Ltd´s anti-clotting drug prasugrel, which industry analysts have said was most likely due to a backlog at the FDA, or small issues with the labeling.

Alogliptin-SYR-322 belongs to a new class of diabetes drugs called DPP-4 inhibitors, and if approved, would be competing with Merck & Co´s Januvia ($ 606 million dollars in 1H2008), the only DPP-4 inhibitor approved for marketing in the U.S.

Submitted in July 2008 and under review by the FDA and Europe´s regulating agency EMEA is Bristol-Myers Squibb/AstraZeneca´s experimental diabetes DPP-4 inhibitor Onglyza.

Takeda has also sought U.S. approval for a combination alogliptin-Actos pill.