Japanese pharmaceutical company Takeda is scrambling to recover as its once top-selling diabetes drug, Actos, loses market share to generic versions and as Actos lawsuits continue to mount.

Over the six-month period ending Sept. 30, 2012, sales of Actos decreased 46.2 percent from the previous year. From 2011 to 2012, Takeda estimates that sales of Actos will decline 67 percent.

The losses are significant, as Actos sales contributed to 20 percent of Takeda’s revenue in 2011. Evidence of Takeda’s decline in profits became apparent in July 2012, as the company’s stock fell to an 11-year low.

Takeda Seeks Profits from New Drugs

Takeda is turning to new drugs like Adcetris, Alogliptin and Nesina to try to recover.

Adcetris, which is used to treat lymphoma, was approved in the United States in 2011 and brought in $70 million during its first six months of availability. Adcetris was recently approved in Europe.

Takeda has tried unsuccessfully to receive Food and Drug Administration (FDA) approval of its new diabetes drug, alogliptin. The drug manufacturer had hoped that this drug could help it recover some of the lucrative diabetes drug market.

Alogliptin is used to treat type 2 diabetes, which occurs when a patient does not produce enough insulin or does not use insulin efficiently.

Nesina, which is the name brand for alogliptin, is building revenue for Takeda in Japan.

Actos Continues to Lose Money

For Takeda, the days of huge Actos profits are over, as generic versions of the drug flood the market and lawsuits over Actos’ side effects number in the hundreds.

Pharmaceutical companies Watson, Ranbaxy, Teva and Mylan are now manufacturing generic Actos — and capturing large chunks of the $2.7 billion-a-year Actos market.

Meanwhile, the number of Actos lawsuits against Takeda is expected to reach 10,000. The claims focus on the dangerous side effects of Actos, including eye disease, bone fractures, congestive heart failure and bladder cancer, which can be fatal. Hundreds of cases have been consolidated into a multidistrict ligitation (MDL) in the U.S. District Court for the Western District of Louisiana.

Despite carrying a black-box warning that the FDA requires for drugs that may pose serious or life-threatening risks, around 10 million people worldwide have taken Actos.

Takeda may face yet another fiscal blow as its 10-year study on the side effects of Actos comes to an end. Results from the study, which are expected in 2013, could be devastating and are likely to influence litigation.

Read more... http://www.drugwatch.com/2012/11/06/actos-sales-fall-46-percent-as-lawsuits-continue-to-pile-up/