Takeda Pharmaceutical Company Limited and its wholly owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. have announced that moremore than 96% of eligible claimants have opted into the Actos (pioglitazone HCl) product liability resolution program that was announced on April 28, 2015. Takeda now is evaluating the submissions to determine whether they satisfy various criteria specified under terms of the resolution program. Takeda expects the resolution program to become effective upon completion of that review. Actos is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with Type 2 diabetes.

Per the resolution program, a 95% participation or greater triggers a $2.37 billion dollar payment by Takeda into a settlement fund. However, that figure will rise to $2.4 billion if after a review of the claims submissions it is determined that 97% or more of them meet the settlement criteria. The settlement would not affect Takeda’s ability to pay dividends.

Once the settlement is operative, the company also will have resolved seven of the nine previously tried Actos product liability cases, which have been in various stages of the appeals process. In Cooper v. Takeda, which was tried in Los Angeles, California, Takeda is appealing from a judgment against the company. In Triana and Cipriano v. Takeda, the plaintiffs are challenging through post-trial motions a judgment in favor of Takeda.

“Takeda's decision to pursue this settlement does not change the company's continued commitment to Actos,” said Takeda in a statement. Actos continues to be available as a treatment option in the US and other countries. The drug has been approved for use in 95 countries, including the US, Japan, several in Europe, Australia, Brazil, Canada and Russia, to highlight a few.

In a statement, Takeda said it “believes the company acted responsibly with regard to Actos and firmly stands behind the substantial data confirming a positive benefit/risk profile for Actos. The data sets include a 10-year, prospective cohort study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California, which showed no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone, and the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large multi-database retrospective matched cohort study.”

Takeda said that the settlement would reduce the uncertainties of complex litigation for the company and resolve a high percentage of the Actos product liability claims.

Source: Takeda