Takeda Pharmaceutical, the top Japanese drug maker, agreed to pay around $2.4 billion to settle lawsuits which raised claims over Actos diabetes drug to have risk of cancer.
The agreement would resolve lawsuits representing some 8,000 people who used the treatment for type 2 diabetes beginning in the late 1990s and claimed the company did not warn them that it increases the risks of cancer.
Takeda said that it agreed to pay out $2.37 billion if 95% of the litigants agree to the deal, rising to $2.4 billion if the number rises to 97% or more. It believes the claims of the litigants "are without merit and does not admit liability."
"Takeda believes the company acted responsibly with regard to Actos and that Actos has a positive benefit/risk profile for the treatment of type 2 diabetes," it said.
Takeda said the settlement does not change its continued commitment to Actos, or pioglitazone hydrochloride. Actos continues to be available as a treatment option in the US, Japan and other countries.
Last year a federal jury in Louisiana ordered Takeda and US-based Eli Lilly & Co to pay a combined $9 billion in punitive damages to a patient who said Actos had caused his bladder cancer. A judge later slashed the payout to $36.8 million.
Eli Lilly was Takeda's US marketing and sales partner until 2006, with the US firm keeping the rights to sell Actos in parts of Asia and Europe, as well as in Canada and Mexico. Takeda said it was taking a $2.7 billion charge in its fourth quarter earnings to cover the settlement and related costs.
"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.