Takeda fesses up to improperly marketing its blood-pressure blockbuster, Blopress

Takeda CEO Yasuchika Hasegawa

Japan's health ministry is one of the world's toughest when it comes to demanding truth in advertising. The newest target of its scrutiny is Takeda Pharmaceutical, which is now admitting it may have mismarketed its hypertension drug Blopress. Takeda's CEO, Yasuchika Hasegawa, told reporters at a news conference on Monday that the company used "inappropriate expressions" to advertise the drug, according to The Wall Street Journal.

The admission comes a week after a doctor in Japan pointed out that an ad for Takeda's drug contained data that didn't match the results of a clinical study. The health ministry launched an investigation into the question, which involved a clinical trial concluded in 2006 that compared Blopress (candesartan) to Pfizer's ($PFE) Norvasc (amlodipine). The ad suggested that Takeda's drug was the more effective of the two, despite the fact that the trial results indicated no discernible difference.

Takeda said the ad contained a graph that had been presented during an academic conference in 2006, rather than data showing the results of the head-to-head trial, which was published two years later, according to the WSJ. The company acknowledged the switch could cause confusion over how the two drugs actually compare.

"We deeply regret and apologize for the fact that our promotional activities were partially inappropriate," Hasegawa said during the news conference.

In Japan, it's illegal for a company to engage in exaggerated or misleading advertising, and the penalties can include up to two years in prison and/or a fine of up to ¥2 million (about $19,600). This latest investigation follows close on the heels of a probe into Novartis' ($NVS) marketing of its blood pressure drug, Diovan. Japan filed a criminal complaint against Novartis in January, alleging the company manipulated data used in ads suggesting Diovan (valsartan) could prevent strokes or angina.

It's been a tough run for Takeda on the legal front. The company is facing thousands of lawsuits alleging it didn't properly flag potential cancer risks associated with its diabetes drug, Actos. In September a jury ruled against Takeda in an Actos case, though the judge did throw out the $1.7 million damages award. A long-term study of the drug's risks that was ordered by the FDA is set to conclude this year. Meanwhile, a whistleblower case involving a Takeda sales manager who says the company pushed higher-than-approved doses of a stomach drug is pending before the Supreme Court.

Blopress was bringing in nearly $2 billion in sales for Takeda before it went off-patent in 2012. Takeda plans to set up an external panel to investigate what went wrong in its marketing of the drug. The company maintains that it didn't violate the law, however, because it didn't manipulate or fabricate any research data.

- here's the WSJ story (sub. req.)
- read more at PMLive

Special Reports: The top 10 largest pharma layoffs in 2013 - Takeda | 10 Largest U.S. Patent Losses of 2012 - Actos