J&J, Legend tap Novartis to help make CAR-T drug Carvykti as they work through supply constraints

Struggling to meet demand for CAR-T med Caryvkti, Johnson & Johnson and Legend Biotech have reached out to another cell therapy expert for help manufacturing their multiple myeloma treatment.

Novartis has signed a three-year contract to manufacture Carvykti, also known as cilta-cel, Legend said in a securities filing Friday.

In a statement to Fierce Pharma, Novartis confirmed that it will supply Caryvkti from its cell therapy site in Morris Plains, New Jersey, which is about 20 miles from J&J and Legend’s CAR-T facility in Raritan, New Jersey.

The agreement only covers Carvykti supply for clinical trials outside of China, Legend CEO Ying Huang, Ph.D., told Fierce Pharma via email. Ying declined to offer additional details on the deal’s financial terms or the specific manufacturing capacity involved.

The contract manufacturing deal took effect on Wednesday. But technology transfers can take as long as 18 months, and first, the new manufacturing plan must get a separate FDA go-ahead, Ying said.

Even though Novartis won’t take part in commercial manufacturing for Caryvkti, the extra clinical capacity could help J&J and Legend channel more resources toward ramping up commercial supply.

Despite their phased launch starting at just a few large hospitals, J&J and Legend have had difficulties meeting demand for Carvykti, partly thanks to a global shortage of viral vectors that are used to deliver cell and gene therapies. In contrast to long waiting lists and what J&J CEO Joaquin Duato described as a “strong demand,” Carvykti’s sales plateaued in the fourth quarter at $55 million, the same as its haul in the third quarter.

J&J also scrapped a plan to launch Carvykti in the U.K. Last month, local health organization Myeloma UK suggested that the company simply couldn’t produce enough supply to support the rollout.

Meanwhile, the partners have been busy expanding their capacity. Last year, J&J and Legend unveiled a plan to invest an additional $250 million in their Raritan facility over the next few years to scale up production.

“It’s worth pointing out that, even though we have onboarded Novartis as a [contract manufacturer], we remain focused on providing the product in a reliable and consistent manner through continuous improvement of processes, building a state-of-the-art Belgium facility and expanding internal lentivirus production,” Ying said.

Looking forward, a recent phase 3 success could catapult Carvykti into earlier treatment of myeloma, potentially giving the therapy a larger patient pool and further tightening the supply-demand bottleneck.

Novartis is in a different situation. After a surprise phase 3 flop in earlier treatment of large B-cell lymphoma, Novartis’ CAR-T therapy Kymriah has recently lost its momentum. In 2022, Kymriah sales declined 2% at constant currencies to $536 million.

But as one of the first manufacturers of CAR-T therapies, Novartis has plenty of experience in making these complicated, personalized treatments. Without the extra demand from Kymriah, the Swiss pharma can spare some of its production capacity.

Novartis’ overall contract manufacturing business is expanding, as well. In 2022, revenues from Novartis' manufacturing services nearly doubled to $214 million.