Takeda shares fall on Actos cardiac safety fears

The shares of Japan's largest pharmaceutical company, Takeda, fell 1.8 per cent after the company said it would comply with an FDA request to strengthen cardiac safety warnings on its Actos (pioglitazone) diabetes drug.

Takeda shares fell JPY 150 (USD 1.22), or 1.8 per cent, to JPY 8,190 (USD 66.61) on the Tokyo Stock Exchange, which was the largest single drop since 27 March 2007 and erased most of the stock's 2.1 per cent gain for 2007.

Actos has come under scrutiny since GlaxoSmithKline's (GSK) competitor product Avandia (roseglitazone) was forced to display warnings that those taking the product risked heart failure. Takeda will add the stronger caution, the company said in a statement.

The strengthened label warning will affect sales of Actos, which accounted for almost 25 per cent of Takeda's total FY06 revenue. Actos was first marketed in 1999 for type II diabetes, and had initially gained a share of Avandia's prescription after a New England Journal of Medicine (NEJM) article linking the drug and cardiac disease was published back in March 2007. Doctors wrote 40 per cent fewer prescriptions for Avandia in the two weeks following the report, switching patients over to Actos.

Tokai Tokyo Research Centre analysts have said that the switch in diabetes prescriptions to Actos from Avandia would not be as fast' as some investors had anticipated. They added that Takeda has previously reported the risk of heart failure and was now repeating that warning to doctors.

The FDA asked for the revision to the Actos labelling to include heart-failure risks listed in the prescribing information, more than a year after agency safety reviewers initiated the action. The new warnings for Actos and Avandia alert doctors and patients to congestive heart failure.

GSK's own preliminary data from a study published on 5 June found that Avandia doubled the chances of the condition developing, but did not increase the chances of heart attack and death.

A spokesperson for Takeda's North American Unit, TAP, said in a statement that the company remained confident in the safety and efficacy of Actos when used according to its label, and with this revision, the company would be able to heighten patient and physician awareness of an already known, but serious side effect.

Takeda predicts that worldwide sales of Actos may fall to between 10 and 20 per cent in FY07 after climbing 38 per cent to JPY 336.3bn (USD 2.8bn) in FY06. Actos sales in the US rose 33 per cent to rest at USD 2.4bn in FY06.