J&J and Legend Biotech Expand Cell Therapy Manufacturing Capacity Amid Growing Demand for Carvykti

Johnson & Johnson (J&J) and Legend Biotech are ramping up their cell therapy manufacturing capabilities with a $150 million investment in their Belgium facility. This move comes as the companies prepare to meet increasing demand for their multiple myeloma therapy, Carvykti, and face potential competition in the market.

Expansion of Manufacturing Facilities

J&J and Legend Biotech have approved approximately $150 million in additional investments to expand the future capacity of their new facility in Ghent, Belgium. The expansion is based on internal projections for demand, as revealed by Legend CEO Ying Huang, Ph.D., and interim Chief Financial Officer Jessie Yeung during a recent investor call.

The Tech Lane facility in Ghent is set to begin clinical production of Carvykti within weeks and is expected to gain approval for commercial supply by the end of 2025. The newly announced expansion will primarily focus on providing supplies for the EU market, with construction slated to start in the second half of 2025 and completion expected in 2028.

This latest investment is part of a broader strategy to boost cell therapy manufacturing capacity. Other recent developments include:

• FDA approval for contract manufacturer Novartis to produce commercial supply of Carvykti at its site in Morris Plains, New Jersey.
• A $500 million total investment in J&J and Legend's flagship Raritan manufacturing facility in New Jersey, with regulatory approval for a new section expected in the second half of this year.
• The Obelisc facility in Ghent, which began commercial production in Q3 2024 and is now operating at full capacity.

These expansions are aimed at reaching the companies' goal of producing 10,000 doses of Carvykti annually by the end of 2025.

Market Dynamics and Growth Strategies

Carvykti has faced supply constraints since its initial FDA approval in early 2022, limiting revenue growth. However, an expanded FDA approval in April 2024 for second-line multiple myeloma treatment has roughly tripled the therapy's eligible patient population.

To capitalize on this expanded market, J&J and Legend are implementing strategies to increase adoption in community settings, where most multiple myeloma patients are treated. Their three-stage plan includes:

1. Educating over 8,000 community oncologists about Carvykti and facilitating patient referrals to certified treatment centers.
2. Identifying regional hospitals and community accounts affiliated with large hospitals to administer Carvykti on-site, starting later this year.
3. Expanding administration to community oncology practices more widely, beginning next year.

The companies are also benefiting from increased outpatient administration of Carvykti, which has grown from about 30% a year ago to more than 50% today. This shift helps increase overall treatment capacity by freeing up limited inpatient space.

Competitive Landscape and Future Challenges

As J&J and Legend expand their manufacturing capabilities, they face potential competition from Gilead Sciences and Arcellx's rival BCMA CAR-T therapy, anito-cel. In a pivotal phase 2 trial, anito-cel demonstrated competitive efficacy and better safety compared to Carvykti, although cross-trial comparisons have inherent limitations.

Legend's executives downplayed the potential threat, arguing that anito-cel would initially enter the late-line treatment setting, while the majority of Carvykti's revenue is expected to come from earlier lines of treatment by the end of 2025.

The companies are also addressing concerns about delayed neurotoxicities associated with Carvykti treatment. A recent study by the Colorado Blood Cancer Institute suggested that prophylactic treatment with dexamethasone may mitigate these effects. Legend is incorporating this mitigation strategy into ongoing Cartitude trial programs and is discussing potential investigator-initiated trials to further study the phenomenon.

As the cell therapy landscape continues to evolve, J&J and Legend's significant investments in manufacturing capacity and market expansion strategies position them to meet growing demand for Carvykti while navigating emerging competitive challenges.