Novartis to make Carvykti for Johnson & Johnson and its partner Legend Biotech to meet demand, says firm. 

In March 2022, the US Food and Drug Administration (FDA) approved chimeric antigen receptor T-cell (CAR-T) therapy Carvykti (ciltacabtagene autoleucel; ciltacel). For the first three months of 2023, the multiple myeloma therapy pulled in $72 million in sales, up from $55 million quarter-on-quarter.

J&J’s chief financial officer Joe Wolk said on the earnings call the firm is experiencing “really tremendous demand” for Carvykti.

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To meet this, a securities filings published last week announced Novartis has signed a three-year contract with J&J and its partner Legend Biotech to produce Carvykti. The deal took effect April 12, and a technology transfer will occur to transfer activities required for Novartis to perform the process for production of Carvykti in order to supplement the partners’ own manufacturing capabilities.

“We did sign on for additional capacity to scale up some production and increase availability moving forward,” Wolk said during the earnings call.

“The manufacturing is ramping up to supply markets. We have really tremendous demand given some of the data that supports […] Carvykti the CAR-T for Johnson & Johnson. And we’re committed to doing everything we can to accelerate our manufacturing abilities to meet that demand.”

Among J&J’s investments is the construction of a large-scale EMEA viral vector facility in Sassenheim, the Netherlands, which will provide raw materials to its CAR-T production center in Ghent, Belgium. The firm has also repurposed capacity in the US to support its cell therapy ambitions.

These projects “continue to progress,” said Wolk, adding they “will serve as important parts of our supply chain network for not just this but other cell therapies in the future.”

Supply issues

In March 2023, J&J halted the launch of Carvykti in the UK and patient advocacy group Myeloma UK said it believes this is because of supply issues. 

While the firm did not explicitly specify why it has decided to stop the launch as it does not comment on manufacturing capacity, a spokesperson told us “There are multiple clinical, patient, and logistical factors that can impact the production of cilta-cel, which differs from small molecule or biologic oncology therapies. Despite focused efforts, Janssen is not currently in a position to progress with the NICE appraisal process.”

For the first quarter 2023, Johnson & Johnson (J&J) reported worldwide sales of $24.7 billion, a 5.6% increase year on year with its pharmaceutical business contributing $13.4 billion of this.