J&J and Legend Biotech Ramp Up Carvykti Production with $150M Investment

Johnson & Johnson (J&J) and Legend Biotech are making significant strides to expand the production capacity of their CAR-T therapy, Carvykti, with a new $150 million investment in manufacturing facilities. This move comes as the companies aim to meet growing demand and achieve blockbuster status for the multiple myeloma treatment in 2025.

Manufacturing Expansion and Capacity Goals

Legend Biotech is constructing a new $150 million manufacturing plant in Ghent, Belgium, in partnership with J&J. The facility, dubbed Tech Lane, is expected to begin clinical production within weeks and transition to commercial production later this year. This expansion is part of a broader strategy to double Carvykti production in 2025.

The investment in Belgium follows other recent manufacturing initiatives, including:

• FDA approval for Novartis to produce commercial supply of Carvykti at its Morris Plains, New Jersey site
• A $500 million investment in J&J and Legend's flagship Raritan, New Jersey facility
• The Obelisc facility in Ghent, which began commercial production in Q3 2024

These expansions are crucial in reaching the companies' goal of producing 10,000 Carvykti doses annually by the end of 2025. Alan Bash, Legend's president of Carvykti, stated, "By the end of this year, we'll be in a situation where supply is fully meeting the demand where we are, and then we'll be able to keep pace."

Market Performance and Future Outlook

Carvykti, approved by the FDA in February 2022 for relapsed or refractory multiple myeloma, saw its indication expanded to second-line treatment in April 2024. This expansion has significantly increased the eligible patient population.

In 2024, Carvykti sales reached $963 million, just shy of blockbuster status. Legend Biotech aims to cross the $1 billion threshold in 2025, with the new manufacturing investments playing a crucial role in achieving this goal.

The therapy is currently available at 104 certified treatment centers in the U.S., with a growing trend towards outpatient administration. Over 50% of Carvykti treatments are now conducted in outpatient settings, up from 30% a year ago. This shift is expected to increase overall treatment capacity and boost demand.

Competitive Landscape and Clinical Developments

As J&J and Legend Biotech focus on expanding Carvykti's market presence, they face potential competition from Gilead Sciences and Arcellx's BCMA CAR-T therapy, anito-cel. However, Legend's CEO, Ying Huang, downplayed the threat, noting that by the end of 2025, the majority of Carvykti's revenue is expected to come from earlier treatment lines.

Recent clinical developments include a study by the Colorado Blood Cancer Institute suggesting that prophylactic treatment with dexamethasone may mitigate neurotoxicities associated with Carvykti. Legend is incorporating this mitigation strategy into ongoing Cartitude trial programs and exploring further research through investigator-initiated trials.

As the CAR-T therapy landscape continues to evolve, J&J and Legend Biotech's significant investments in manufacturing capacity demonstrate their commitment to meeting patient demand and solidifying Carvykti's position in the multiple myeloma treatment market.