J&J, Legend expand manufacturing deal with Novartis to include commercial production of Carvykti

With sales on the rise for Legend and Johnson & Johnson’s multiple myeloma CAR-T Carvykti and in decline for Novartis’ leukemia CAR-T Kymriah, a manufacturing partnership makes sense—especially considering they produce their respective treatments 20 miles apart in northern New Jersey.

This week, the companies expanded a previous agreement, with Legend and J&J tapping Novartis to perform commercial manufacturing for Carvykti (cilta-cel). Legend revealed the deal in a regulatory filing on Friday. 

The new deal runs through the end of 2029, with Novartis agreeing to set aside a specified number of production suites at its facility in Morris Plains, New Jersey. Legend and J&J committed to meet specified volume targets and to a tiered pricing arrangement, depending on how many batches they order.

“This agreement allows Novartis to maximize capabilities in a different portion of the Morris Plains facility with no impact on the global capacity required for its own cell therapies, including Kymriah and the next generation T-Charge cell therapies,” a Novartis spokesperson wrote in an email.

In April of last year, the companies made a similar agreement which was limited to three years and was for production of Carvykti for clinical trials, excluding those in China.

Along with another producer of CAR-T products, Bristol Myers Squibb, J&J and Legend have encountered manufacturing pitfalls since gaining FDA approval of Carvykti two years ago. But four months ago, Legend and J&J reported that their new facility in Ghent, Belgium, was ready for clinical production, taking some of the onus off their plant for commercial production in Raritan, New Jersey.

During a conference call in October of last year, J&J’s R&D chief John Reed, M.D. Ph.D., described the lentivirus portion of Carvykti as “rate-limiting.” Lentiviral vectors are expensive delivery components used to introduce the chimeric antigen receptor (CAR) construct to patients’ T cells.

Another J&J factory in the Netherlands is expected to come online in 2025 to support Carvykti’s lentivirus component, Reed said.

Earlier this month, Legend reported that sales of Carvykti reached $500 million last year, with $159 million of that coming in the fourth quarter. Earlier this year, J&J said the companies expected sales to reach $4.5 billion by 2027.

Last year Novartis reported sales of $508 million for Kymriah, down from $534 million in 2022 for the CAR-T that was approved in 2017. Novartis is rapidly expanding its commercial manufacturing unit, generating (PDF) sales of $1.5 billion last year, a 24% increase from 2022.