With approvals in the U.S and Europe expected soon, it looked like Takeda would have time to get its new multiple myeloma treatment into the market before patents fell off of blockbuster Velcade in 2022. But CEO Christophe Weber may need to plot a new strategy after a federal judge overturned a key patent, putting the Japanese drugmaker's drug vulnerable to generics 5 years early.
U.S. District Judge Gregory Sleet struck down the patent Thursday, Bloomberg reports. The patent was being challenged by Allergan's ($AGN) Actavis, Novartis' ($NVS) Sandoz and Accord Healthcare.
The injected treatment is one of Takeda's top sellers and pulled in 41.8 billion yen ($340 million) in the first quarter for Takeda. It is sold by Johnson & Johnson ($JNJ) outside the U.S. "We are currently reviewing the official ruling and evaluating next steps," Elizabeth Pingpank, a U.S.-based spokeswoman for Takeda, told the news service in an email.
Takeda's submitted ixazomib, also a treatment for treating the blood marrow cancer, to the FDA in July and to European regulators just last week. Like Velcade and Amgen's ($AMGN) Kyprolis, ixazomib is a proteasome inhibitor, designed to kill tumors by cutting off the production of proteins they need to grow. But ixazomib has the advantage of being an oral treatment and the drugmaker is expecting it to eventually hit blockbuster sales. Getting there has taken on more urgency after the drugmaker experienced some late-stage setbacks in oncology with lymphoma and prostate cancer treatments.
"This is a blow because no drug company wants to lose any patent protection on its top product," Erik Gordon, a University of Michigan law professor told Bloomberg in an emailed statement.
|Takeda CEO Christophe Weber|
It is particularly a blow to Weber, who took on the CEO title earlier this year and is Takeda's first non-Japanese leader. In his debut earnings report in May, the company reported a small loss for the year, but he promised the a corner had been turned and that the company would be profitable this year.
The loss, he said, was mainly tied to the charge it took after agreeing this spring to settle for $2.3 billion cases tied to risks of it diabetes drug Actos, a product whose patent loss contributed to Takeda's need for a turnaround. But there are signs that settlement is in trouble, which may leave Takeda having to chip in more money to get it done. Takeda has said it will consummate the deal when it has 95% of patients on board but when the first deadline came Aug. 12, only about 75% of plaintiffs signed up, prompting Takeda to extend the deadline another month.
- read the Bloomberg story