Takeda to start key diabetes drug trial in Sept

TOKYO Aug 28 (Reuters) - Takeda Pharmaceutical (4502.T), Japan's largest drugmaker, said on Friday it is set to start an additional clinical study on a key diabetes drug candidate next month, setting a timeline that could see it receive U.S. approval in 2012.

Takeda had originally aimed to have the drug alogliptin or SYR-322 on the market ahead of the 2011 U.S. patent expiration of its blockbuster diabetes drug Actos but its application for approval suffered a setback when U.S. health regulators requested an additional safety test.

It expects to report data from the new study in about two years, it said in a statement.

"We would normally receive a response from the Food and Drug Administration six months after data submission, however, the timing depends on conditions," a Takeda spokeswoman said.

It will start the placebo-controlled examination, involving 5,400 Type 2 diabetes patients at a total 1,000 facilities in the United States, Europe and Asia, Takeda said, adding that U.S. regulators had agreed to the design of the trial.

Credit rating agency Moody's Investors Service on Thursday changed the outlook on its Aa1 rating for Takeda to negative, saying revenue growth and earnings may be pressured by a series of U.S. patent expirations for core products. [ID:nWLA2036] (Reporting by Yumiko Nishitani; Editing by Edwina Gibbs)