Takeda Pharmaceutical and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., have reached an agreement expected to resolve the vast majority of ACTOS (pioglitazone HCl) product liability lawsuits in the U.S.
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Takeda will take a $2.7 billion charge against earnings in the fourth quarter of fiscal year 2014 to cover the settlement and the costs associated with defending remaining cases and for other related litigation.
The settlement will become effective if 95 percent of current litigants and claimants opt into the settlement. Once that threshold is achieved, Takeda will pay $2.37 billion into a settlement fund. However, that figure will rise to $2.4 billion if 97 percent or more of the current litigants and claimants opt to participate in the settlement.
Takeda believes that the claims made in this litigation 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.
Takeda's decision to settle does not change the company's continued commitment to ACTOS. ACTOS continues to be available as a treatment option in the U.S., Japan and other countries. Pioglitazone has been approved for use in 95 countries, including the U.S., Japan, several in Europe, Australia, Brazil, Canada and Russia, to highlight a few.
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. The settlement allows the company to fully focus on developing innovative medicines for patients around the world.
Under the settlement, current litigants and claimants who meet prescribed criteria would receive payouts from the fund. The settlement will not affect Takeda's ability to pay dividends.
Takeda 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. ■