Deerfield, ILWhile various signs point to positive expectations for Actos manufacturer Takeda Pharmaceuticals, analysts and investors are nonetheless keeping a wary eye on the fortunes of Actos—and, specifically Actos bladder cancer—given a steady stream of lawsuits alleging such Actos side effects.
The first hearing associated with an Actos lawsuit is expected to get the green light after a March 22nd status conference. US District Judge Rebecca Doherty was assigned to the consolidated Actos lawsuit cases by the US Judicial Panel on Multidistrict Litigation, in December of last year.
Meanwhile, BMI Asia Pacific Pharma and Healthcare Insights will report on March 1 that Takeda posted mixed results for the nine months ending December 31, 2011. While sales increased and investor sentiment toward Takeda is said to be improving, there are concerns related to Takeda's newly acquired exposure to Europe, a minimal presence in China together with ongoing questions over the safety of Actos.
The latter is a Type 2 Diabetes medication long thought to carry less risk than GlaxoSmithKline's Avandia. However, there have been recent revelations surrounding Actos and bladder cancer, as well as other adverse heath events including Actos heart failure.
Actos has reportedly been withdrawn from the market in some countries, although the US Food and Drug Administration (FDA) is continuing to study Actos. There are limited options for treating Type 2 Diabetes, which is growing amongst the largest segment of the population.
BMI will report on March 1 that Takeda could be facing upwards of 10,000 lawsuits in the US alleging Actos bladder cancer and other side effects. It has been reported that a Takeda-funded clinical study in June of last year revealed an increased risk for bladder cancer. Legal teams representing Actos lawsuit plaintiffs have indicated the presence of evidence showing Actos as having a clear and strong link to an increased cancer risk.
Takeda also reportedly announcing a reduction to the size of its global workforce, cutting nine percent by March 31, 2016. BMI reported that most of the estimated 2,800 redundancies would occur in Europe as well as the US in an attempt to shave $1.7 billion.
Actos was approved by the FDA in 1999 and enjoyed slow, but steady growth until 2008, when the Avandia issue surfaced. Identified as carrying less risk for Actos heart failure than Avandia, sales of Actos exploded and the latter quickly became a top-seller. Takeda Pharmaceuticals has since removed Actos from markets in Germany and France last year at the behest of health regulators there. However, the FDA—while warning about the potential for Actos bladder cancer in 2010—decided to leave Actos on the market.
Many an Actos bladder cancer lawsuit has ensued, over the interim.
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