In a major lift for Takeda and its aging multiple myeloma blockbuster Velcade, a U.S. appeals court overturned a ruling that invalidated a key patent, granting new exclusivity that should translate to significant sales over time.
Takeda will have exclusive protections on Velcade until 2022 because of the court’s Monday opinion, which found the “district court erred” in its decision to strike down a key Velcade patent.
That's a coup for Takeda, which relies on Velcade's revenue and had braced for generic rivals later this year. The cancer medication brought in an estimated $1 billion in the U.S. last year, and now it can continue fueling Takeda's efforts to develop new drugs—and build sales of its new oral multiple myeloma med, Ninlaro—that can make up the difference when generics do arrive.
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It's also a potential boost for Amgen. Cheaper Velcade copycats would have competed with Amgen's multiple myeloma med Kyprolis, too, at a time when Amgen is trying to expand its market.
In the Velcade appeal, the generic company “defendants did not establish the obviousness of the asserted claims of the ’446 Patent by clear and convincing evidence,” according to Monday's opinion. “The district court’s judgment of invalidity is reversed,” the document states.
Novartis’ Sandoz unit was one of a dozen companies challenging the patent. Also among them were Mylan, Teva Pharmaceuticals, Glenmark, Sun Pharma and Pfizer’s Hospira unit. Takeda sued after the companies registered their challenges with the FDA.
Following that 2015 district court ruling, Velcade’s exclusivity was expected to expire in November. The drug pulled in more than $1 billion in the U.S. alone last year, according to estimates from analysts at the life science commercial intelligence firm Evaluate. Velcade ranked No. 4 on FiercePharma’s May report detailing the top U.S. patent expirations for this year.
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Previously, Evaluate analysts predicted the drug would fall to $187 million in sales by 2022 as cheap rivals entered the market following the patent expiration. That’s set to change with the appeals court's decision.
Meanwhile, Takeda has high hopes for its followup oral medication to Velcade, Ninlaro, which CEO Christophe Weber has said is a “significantly bigger” opportunity than its predecessor. Weber said he believes the newer medication can grow past $3 billion in annual sales.
Takeda also recently completed a $5.2 billion buy for Ariad and is in the process of launching newly approved Alunbrig as a second-line treatment for ALK-positive, non-small cell lung cancer. That medication also has blockbuster potential, according to the company’s helmsman.