Takeda’s chief executive Yasuchika Hasegawa has admitted the company may have used “inappropriate” language in its marketing of blood pressure blockbuster Blopress, but denied any data falsification.
Hasegawa told the Wall Street Journal that the company had used a graph in promotional literature indicating Blopress (candesartan cilexetil) was more effective than rival blood pressure drug Norvasc (amlodipine) from Pfizer which was not supported by clinical data.
Blopress – also sold as Atacand – was a big seller for Takeda for many years, with sales approaching $2bn before it lost patent protection in 2012.
The Japanese authorities started an investigation into the case after a doctor spotted the graph in an advertisement and questioned whether it reflected the published results from the trial.
The mis-marketing stemmed from a trial initially reported at a medical conference in 2006 and subsequently published in the journal Hypertension two years later, according to Hasegawa.
The advertising erroneously carried a graph that was used when the data was first presented which accounted for the discrepancy in the data, he added, and an internal investigation revealed no evidence of data falsification or conflict of interest.
Takeda also admitted that its marketing material contained misleading statements indicating that Blopress was more effective than Norvasc, although the company said it did not believe it had violated Japanese law in running the ads.
The incident comes amid increased scrutiny of pharma marketing practices in Japan, just days after a local Novartis subsidiary was raided as part of a probe into alleged mis-promotion of its blood pressure medicine Diovan (valsartan). That investigation centres on suggestions that data from trials was falsified to inflate the clinical benefits of Diovan.
Last year, GlaxoSmithKline dismissed the head of its Chinese R&D unit after it emerged data from multiple sclerosis study published in Nature Medicine in 2010 had been manipulated.