Takeda settles Actos damages case for $2.7bn

Takeda has agreed to pay an eye-watering $2.7 billion to settle claims that its diabetes drug Actos caused bladder cancer, in one of the largest cases of its kind in the pharma industry.

The Japanese drugmaker insists that the claims linking Actos (pioglitazone) to cancer are without merit and denies any liability, but clearly wants to put the long-running lawsuit in its rear-view mirror.

“The settlement will reduce financial uncertainties for the company and provides a significant degree of assurance toward resolving a high percentage of the Actos product liability claims,” it said in a statement. The settlement only becomes effective if 95 per cent of claimants opt in, it noted.

Around 9,000 claims are estimated as pending in the long-running dispute, which first emerged several years ago and led to the withdrawal of Actos from the market in France and Germany. Both the US FDA and EMA launched investigations into the link with bladder cancer but concluded it was safe to remain on the market as long as the possible link was mentioned on labelling.

Takeda’s willingness to settle comes after the jury in a US district court awarded damages of $9 billion against Takeda and its Actos marketing partner Eli Lilly, although that was reduced to less than $40 million on appeal.

The settlement is one of the biggest ever agreed by a drugmaker, although it is smaller than the $4.85 billion Merck & Co allocated to set aside lawsuits claiming its Vioxx (rofecoxib) painkiller increased the risk of heart attacks, as well as the $3 billion paid by GlaxoSmithKline (GSK) to settle claims it failed to report safety data for its diabetes therapy Avandia (rosiglitazone).

Other big settlements involving big pharma companies have tended to result from mis-promotion of drugs. They include Johnson & Johnson’s $2.2 billion payment in 2013 to settle claims it marketed schizophrenia therapy Risperdal (Risperdal) and other drugs for unapproved uses in the US, and Abbott’s $1.5 billion fine in 2012 for illegal promotion of epilepsy drug Depakote (divalproex sodium).

Takeda said it “stands behind the substantial data that confirm a positive benefit/risk profile for Actos, which includes more than 14 years of clinical and patient experience with the product.”

The drug brought in upwards of $4 billion at its peak, but succumbed to generic competition in 2012 and has seen a steady decline in sales since then.

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