* Takeda expects to take 2 years to submit test results
* Approval may be delayed until March 2012 or later
(Adds Takeda comments)
TOKYO, June 27 (Reuters) - Takeda Pharmaceutical (4502.T), Japan’s largest drugmaker, said on Saturday a key diabetes drug had failed to get approval from U.S. regulators who had asked for additional safety tests, a process the company predicts could take at least two years.
While much depends on the kind of additional tests needed, approval for the drug might take until the end of the business year to March 2012, or even later, Hisashi Tokinoya, assistant manager of Takeda’s public relations division, told Reuters.
The delay in approval of alogliptin, which Takeda has positioned as a successor to its top-selling drug Actos, was largely expected after the U.S. Food and Drug Administration (FDA) said in March it wanted more data [ID:nT186292].
The FDA’s request gave rise to fears the drug may not be ready to hit the market before Actos’ patent expiration in 2011, and sent Takeda’s shares diving to 10-year lows, although they have since regained much of that lost ground. [ID:nT239013].
Takeda also said this month it would delay seeking European approval for alogliptin, which is also known as SYR-322, to 2012 instead of its original target of this year, to conduct another study.
The study in Europe is separate to the additional one planned for the U.S. market and was decided without prompting from European regulators, Takeda said.
With alogliptin, which belongs to a new class of diabetes drugs called DPP-4 inhibitors, Takeda aims to compete with Merck & Co’s (MRK.N) Januvia, the only DPP-4 on the U.S. market.
Other rival drug candidates, which work through the same mechanism of action, are also in advanced stages of development.
Actos accounts for roughly a quarter of Takeda’s revenues and will lose U.S. patent protection in 2011.
Takeda said to ensure alogliptin is approved in Europe it would conduct an additional two-year 2,500-patient study, comparing its safety to glipizide, a much older generically available diabetes medicine when used in combination with another generic drug metformin.
Takeda shares ended on Friday up 0.8 percent at 3,790 yen. (Reporting by Leika Kihara; Editing by Sugita Katyal)