June 29, 2009 / 6:53 AM / in 9 years

UPDATE 2-Takeda shares hurt by diabetes drug U.S. setback

* Stock ends 2.4 pct lower, underperforms rivals

* Daiwa says may downgrade earnings projections (Adds analyst quote in last paragraph, updates share price)

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. 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. [ID:nSP468416]

Takeda reiterated it was still discussing details with U.S. regulators about the additional study to gather data 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’s shares closed down 2.4 percent at 3,700 yen, underperforming rivals such as Astellas Pharma (4503.T), which dipped 0.6 percent, and Daiichi Sankyo (4568.T), which also shed 0.6 percent.

Takeda’s comments still prompted some analysts to review their outlook on the company.

“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, Miyauchi said.

Some analysts said it would now be more difficult for the Takeda drug to compete 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.

“We see a need to review peak sales estimates for the SYR-322 for the scenario of it becoming the third runner instead of the second runner,” said Kenji Masuzoe, analyst at Deutsche Securities. (Reporting by Yumiko Nishitani; Editing by Michael Watson and Anshuman Daga)

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