Takeda shares plummet as FDA delays new drug

Japanese drug-maker Takeda Pharmaceutical Co fell the most in 21 years on concerns that US approval of its diabetes drug alogliptin, a successor to its bestselling Actos, may be delayed.

Asia's biggest drugmaker dropped 500 yen, or 13 per cent, to 3,320 yen on the Tokyo Stock Exchange, the biggest fall since October 1987, and the second-biggest decliner today among shares that comprise the Nikkei 225 Stock Average.

Takeda announced after markets closed on Friday that the US Food and Drug Administration had said its clinical data on alogliptin were ''insufficient'' because of changes to diabetes guidelines released by the US in December. The second such delay for alogliptin means it probably won't hit the market until after Actos loses patent protection in January 2011.

Takeda will discuss with the FDA whether additional tests are required for cardiovascular risks, while the FDA has maintained its 26 June deadline for assessing the drug's approval application, company spokeswoman Ayako Iwamuro said.

Cardiovascular disease is the leading cause of death among US diabetics, who number about 24 million. Proposed treatments for Type 2 diabetes should follow new testing standards to rule out an ''unacceptable increase'' in heart problems, according to new guidance by the FDA, after US lawmakers demanded a review of testing when GlaxoSmithKline Plc's Avandia was linked to heart attacks.

The recommendations apply to all experimental diabetes drugs, even if studies are in progress or the medicine has been submitted for approval.

Takeda, which hasn't released a new product in the US since the sleeping pill Rozerem in September 2005, applied to the FDA to sell alogliptin, or SYR-322, as a once-daily treatment in December 2007. The FDA postponed its decision on the drug in October because it wasn't able to complete its evaluation of the data, citing ''internal resource constraints''.

Takeda President Yasuchika Hasegawa is counting on alogliptin to prevent a potential Alogliptin is in the same class as Merck & Co's Januvia, which generated $1.4 billion last year in sales. The two medicines are in a new class of diabetes treatments known as DPP4 inhibitors that spur the pancreas to produce more insulin and the liver to make less glucose, or blood sugar.

Meanwhile, drug development contractor PPD Inc said on Friday that it no longer expects a $25 million payment from Takeda Pharmaceutical after that company raised concerns of a regulatory delay for alogliptin.

"As a result of this news, PPD is no longer forecasting the receipt of the $25.0 million alogliptin NDA approval milestone in 2009," the company said in a statement.