TOKYO, Oct 20 (Reuters) - Japan’s Takeda Pharmaceutical Co (4502.T) said U.S. regulators have pushed back the possible approval of a key drug candidate, the latest in a string of delays in the world’s largest drug market.
Japan’s biggest drug maker also said it would beat its first half profit forecast on strong sales and a softer-than-expected yen, and it unveiled plans to buy back up to 50 billion yen ($492 million) worth of its own shares.
Takeda said the U.S. Food and Drug Administration had pushed back the deadline for possible approval of TAK-390MR, a possible successor to its Prevacid ulcer drug, by three months to Jan. 31, due to examination delays but not due to any problem with the drug.
The U.S. patent on Prevacid will expire next year.
U.S. regulators have missed their target dates for assessing a string of drug candidates recently and have blamed staff shortages for slowing the review process. [ID:nN02287148]
Earlier this month Takeda said U.S. authorities had not been able to complete a review of a key diabetes candidate, called alogliptin or SYR-322, on schedule due to a lack of resources.
U.S. regulators have also left hanging the potential blockbuster drug candidate of Eli Lilly (LLY.N) and Daiichi Sankyo (4568.T), the blood-thinner prasugrel, on which a decision was due originally in June and then on Sept. 26.
SYR-322 and TAK-390MR are two of Takeda’s biggest drug candidates on which it is banking to counter likely sales drops in its two best-sellers, the Actos diabetes drug and Prevacid. Actos will lose U.S. patent protection in 2011.
A delay of even a few months beyond the usual six- or 10-month review time can cost companies millions of dollars.
Even so, this should not put Takeda at a competitive disadvantage “because reviews by the FDA have been delayed for everyone, not just Takeda,” said Daiwa Institute of Research analyst Kumi Miyauchi.
Separately, Takeda said it now expects to post a group operating profit of 85 billion yen for the April-September first half, up from a prior estimate for 50 billion yen. It raised its sales estimate to 805 billion yen from 760 billion yen.
However, it left its full-year projections for an operating profit of 280 billion yen on sales of 1.57 trillion yen unchanged for further review. The company is due to announce its first half results on Nov. 4.
“Sales have been stronger than expected. But the company may not upgrade its full-year outlooks, because of the yen’s renewed strength recently,” Daiwa’s Miyauchi said.
Takeda also said it would spend up to 50 billion yen to buy back up to 11 million of its own shares, equal to 1.35 percent fo all stock outstanding, from Tuesday through Nov. 25. (Reporting by Yumiko Nishitani; Editing by Hugh Lawson)