Johnson & Johnson and Legend Biotech hope to hit blockbuster status for Carvykti this year.
Legend Biotech is building a new $150 million manufacturing plant, with its partner Johnson & Johnson, with the goal of doubling the production of its CAR T therapy Carvykti this year, Legend CEO Ying Huang revealed in its fourth-quarter earnings call on Thursday.
Approved in February 2022, Carvykti is a CAR T treatment that targets the B cell maturation antigen, a protein commonly found on B cells. The cell therapy was originally indicated for patients with relapsed or refractory multiple myeloma who had undergone at least four prior lines of therapy. But in April 2024, the FDA agreed to push up its use to the second-line setting.
“While the expansion of Carvykti in the second-line setting and approval of Carvykti in additional geographies will dramatically expand the number of patients who are eligible for Carvykti treatment, we think the number of available commercial manufacturing slots will be the primary driver of revenue . . . over the next 12 months,” William Blair analysts wrote in a note to investors on Thursday.
Legend will use the $150 million to expand its cell therapy facility, called Tech Lane, in Belgium. The biotech expects to start clinical production “in the coming weeks,” according to Huang, building up to commercial production later this year. Legend and J&J will “jointly” invest in the Tech Lane project, which has received approval from both companies’ leadership teams.
In 2024, Carvykti hit $963 million in sales, falling just shy of blockbuster status. Legend wants to earn that distinction in 2025, Huang said during the Thursday call, and the manufacturing investments will help the biotech get there.
Jessie Yeung, Legend’s interim chief financial officer, said the company has already started on engineering and design work for this project, which the biotech expects to complete in 2028.
The Belgium boost comes nearly a year after Legend entered into a supply deal with Novartis. That agreement, which runs from March 27, 2024, through December 31, 2029, has Novartis providing contract manufacturing services for Legend and J&J, providing them with clinical and commercial supply of Carvykti out of its production facility in New Jersey.
Also to boost its Carvykti supply, J&J and Legend in October 2022 poured an additional $250 million into their joint production plant in Raritan, New Jersey.
“From a manufacturing standpoint, we’re very comfortable with the supply network that we’ve built,” Alan Bash, Carvykti president at Legend, said during the call on Tuesday. Production at the Novartis site “is coming online right as we speak,” Bash noted, adding that the biotech will continue to invest in “step ups” and a “physical plan expansion” for its Raritan facility, slated for the latter half of 2025.
