UPDATE 1-Takeda shares hurt by diabetes drug U.S. setback

Mon Jun 29, 2009 12:46am EDT

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* Analysts generally say delay is in line with expectations

* Daiwa says may downgrade earnings projections

TOKYO, June 29 (Reuters) - Shares of Takeda Pharmaceutical (4502.T), Japan's largest drugmaker, fell on Monday after it said it expects a delay until March 2012 or later in U.S. approval of its key diabetes drug SYR-322 [ID:nSP468416].

Takeda said on Saturday it expects a delay in approval of the drug, which the stock market expected, after U.S. regulators repeated on Friday their request made originally in March for an additional study and more safety data from Takeda on the drug.

Takeda reiterated it was still discussing with U.S. regulators details of an additional study on cardiovascular risks.

Analysts said the delay in approval of the successor to Takeda's top-selling drug Actos by around two and a half years from the previously targeted deadline of Friday was generally expected after the regulators' request in March.

Takeda shares fell 1.6 percent to 3,730 yen, underperforming sector rivals such as Astellas Pharma (4503.T), which dipped 0.6 percent, and Daiichi Sankyo (4568.T), which fell 0.5 percent.

Takeda's comments still prompted some analysts to review the company's outlook slightly negatively, however.

"The delay itself was not a surprise," said Kumi Miyauchi, an analyst at Daiwa Institute of Research.

"But we now expect a further one year delay from the previously expected deadline of March 2012 in the drug's approval, as the company has not yet begun the needed additional study, which will take two years," she said.

Daiwa may downgrade its projections for Takeda's earnings outlook for the year to March 2012 and thereafter to reflect increased risks from the debut of the SYR-322 falling well behind the expiry of Actos in January 2011, she said.

Some analysts cited deteriorated competition outlooks for the Takeda drug in the U.S. market for new-type diabetes drugs called DPP-4 inhibitors, where Merck & Co's (MRK.N) Januvia is the only player now.

Bristol-Myers Squibb's (BMY.N) rival drug Ognlyza, which won a positive review in April from the U.S. Food and Drug Administration's outside experts panel, has replaced Takeda's SYR-322 as the likely second debutant in the market, analysts said. (Reporting by Yumiko Nishitani; Editing by Michael Watson)

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