Johnson & Johnson (J&J) and Legend Biotech are determined to expand the reach of their CAR-T drug Carvykti for multiple myeloma, following FDA approval last year. However, their journey has not been without manufacturing challenges. J&J is now providing insights into the state of their cell therapy production on a broader scale as they prepare for substantial market expansion.
In recent months, J&J has been steadily increasing its Carvykti production capacity. Dr. John Reed, Executive Vice President of Pharmaceuticals R&D, revealed these developments during a recent conference call. In addition to their original production site in New Jersey, J&J is on the verge of launching another manufacturing site for Carvykti in Belgium. They also plan to enhance production by tapping into the surplus capacity from Novartis under a relatively new partnership. Reed highlighted that the lentivirus component of Carvykti is a critical factor, as lentiviral vectors are costly delivery components used to introduce the chimeric antigen receptor (CAR) construct into patients’ T cells.
To address this, J&J has made significant progress in-house, increasing production scale at a factory in Switzerland. Looking forward, J&J is in the process of building a new factory in the Netherlands to support Carvykti’s lentivirus component, with expectations for it to become operational in 2025.
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In the next year, pending a successful trial in an earlier treatment setting, J&J and Legend are anticipating an FDA label expansion to treat a wider range of multiple myeloma patients. The decision is expected by next April, with the drug currently approved for fifth-line use in the US. However, like many other cell therapies, manufacturing has posed persistent challenges for Carvykti.
In an effort to overcome these challenges, J&J and Legend significantly increased their investment in their Raritan manufacturing facility in New Jersey last October, bringing the total expenditure at the site to $500 million. This, coupled with the upcoming factory in Belgium, positions them to meet J&J’s ambitious goal of over $5 billion in peak sales, as noted by Legend’s CEO, Dr. Ying Huang, in a conference call last year.
Dr. Huang emphasized that the industry had been grappling with a “supply-constrained environment,” primarily due to a shortage of lentiviral vectors and the limited capacity available for engineering and cultivating therapeutic T cells.
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As of the first nine months of 2023, Carvykti generated $341 million in revenue. While this is a notable figure, it falls short of J&J’s $5 billion target, underscoring the significance of the ongoing manufacturing scale-up efforts.
In light of these manufacturing challenges, J&J and Legend decided not to launch Carvykti in the UK earlier this year, as reported by Myeloma UK. Subsequently, they enlisted the support of Novartis, a Swiss pharmaceutical giant, to assist in the production of their sought-after CAR-T therapy.
