Legend Biotech Corporation (NASDAQ: LEGN), a leading Chinese biotech firm, and its U.S. partner Janssen Pharmaceutical have entered into a comprehensive agreement with Swiss pharmaceutical giant Novartis. The agreement covers technology transfer, manufacturing, and clinical supply services for the co-developed therapy Carvykti (ciltacabtagene autoleucel; cilta-cel). As per the terms, Novartis will supply clinical and commercial contract production services for Carvykti, bolstering the production capacity for the partners. This follows a similar agreement established in April 2023.
Novartis is obligated to initiate production of a specified number of qualified kits reserved by the partners for contract production services post-regulatory approval. The partners will work closely with Novartis to share necessary information for contract production services and to secure the required licenses and permits.
The agreement includes a “quantity commitment” clause, requiring the partners to purchase a specified percentage of qualified kit production every six months, with adjustments allowed for any released kits. Failure to meet the quantity commitment, except under specified exceptions, would require the partner to compensate Novartis for the loss incurred.
Carvykti, co-developed globally with Johnson & Johnson since a 2017 deal, has received approval in the U.S., Europe, and Japan for the treatment of adult patients with recurrent or refractory multiple myeloma (MM) who have undergone at least four prior lines of treatment. The therapy is also awaiting regulatory decisions in China.- Flcube.com
