Takeda Issues Study on Diabetes Drug Actos; Comments on Actos LitigationBy
Takeda Pharmaceutical Company Limited has completed the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Ministry of Health, Labor and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency for pioglitazone- containing medicines, including Actos (pioglitazone HCl), the company’s diabetes drug.
This study was a 10-year epidemiology study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California (KPNC), and was designed to investigate whether patients exposed to pioglitazone were at an increased risk of bladder cancer. “Findings demonstrate that there is no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone, said the company in a press statement. “The primary analysis found no association between the use of pioglitazone and the risk of bladder cancer. Additionally, no association was found between the risk of bladder cancer and the duration of pioglitazone use, increased cumulative dose of pioglitazone or the time since initiating pioglitazone
Pioglitazone has been the subject of recent product-safety litigation. Takeda has gained a favorable ruling in five of the six product liability cases regarding Actos that have been brought thus far, with the exception being a decision in federal district court in Louisiana in which a jury found in favor of the plaintiffs in Terrence Allen, et al. v. Takeda Pharmaceuticals North America, Inc., et al.regarding claims that pioglitazone contributed to a patient’s bladder cancer. The Allen case is the only case to reach trial in the multidistrict litigation pending in the federal courts; Takeda prevailed in all five Actos cases tried in state courts thus far. In the Allen case, the jury awarded $1.475 million in compensatory damages. The allocation of liability was 75% Takeda and 25% Eli Lilly. The jury also awarded $6 billion in punitive damages from Takeda and $3 billion from co-defendant Eli Lilly. Eli Lilly co-promoted Actos with Takeda from 1999 to 2006. Under Lilly’s agreement with Takeda, Lilly will be indemnified by Takeda for its losses and expenses with respect to the US litigation and other related expenses in accordance with the terms of its indemnification agreement.
A federal district court in Louisiana recently rejected a bid by Takeda and Eli Lilly to overturn the combined $9 billion punitive damage when a US district judge of the Western District of Louisiana ruled that the jury had sufficient evidence to make its decision. The court has yet to rule on Takeda and Eli Lilly's post-trial motion for a new trial, or alternatively, a significantly reduced punitive damage award.
“We respectfully disagree with the judgment and await a ruling on our motion for a new trial, or alternatively, a significantly reduced punitive damage award,” said Kenneth D. Greisman, senior vice president and general counsel, Takeda Pharmaceuticals U.S.A., Inc, in a company statement. “The ruling on that motion is expected in the coming weeks.”