Diseases: Multiple myeloma and mantle cell lymphoma
Estimated 2016 U.S. sales: $1.13 billion
U.S. patent expiration date: November 3
Takeda took an unexpected hit on its aging multiple myeloma blockbuster Velcade back in 2015, when a U.S. federal judge invalidated a 2022 patent, clearing the way for a host of generics companies to roll out their knockoffs late this year.
Now, Takeda is bracing for the damage, and it's going to come quickly, Takeda CEO Christophe Weber said during the company's fourth-quarter earnings call. The company is considering launching an authorized generic to soften the blow, if only a bit.
"We expect very rapid loss of our sales with Velcade," Weber said on the call. "Whether we launch or not an authorized generic, it will not change the outcome. We lose a lot, because this is the nature of the U.S. market."
EvaluatePharma analysts predict Velcade will cede nearly $1 billion in U.S. sales by 2022 as generics take their toll. The analysts predict the drug will fall to $187 million in 2022, down from an estimated $1.13 billion in U.S. sales for fiscal 2016, which ends March 31. Through Takeda's third quarter, the drug had brought in 83 billion yen, or about $732 million.
So far, Actavis—now owned by Teva—and Fresenius have FDA-approved copies of the drug. Sandoz and Accord Healthcare are also in the mix.
Osaka, Japan-based Takeda is hoping to take its Velcade downfall in stride. Weber last fall touted a follow-up oral med, Ninlaro, as “significantly bigger” than its predecessor. Weber said he believes the newer med can blow past $3 billion in annual sales. The company has also set aside $15 billion for dealmaking as it scouts for deals that can help grow sales and beef up its pipeline.
By the time Velcade generics hit, Ninlaro "will have developed," Weber said, adding that the newer drug's sales growth will help make up for the loss of Velcade exclusivity. "What we are seeing at the moment in our overall forecast is that we are able to offset the loss of Velcade at a global level so it will not create a massive dent in our growth," he said.