In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.
With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.
“So far, Legend and Janssen have invested $250 million in Raritan [New Jersey] and we will invest another $250 million jointly,” a Legend spokesperson added via email. “The second $250 million will be spent over the next 2-3 years to expand the buildout of our New Jersey site to support peak capacity.”
The buildout is part of efforts to put the companies in position to accommodate for $5 billion-plus in peak projected sales for Carvykti.
Huang said earlier this year that the estimate, which is considerably higher than Bristol Myers Squibb’s estimate of $1 billion for peak Abecma sales, is due to the therapy’s potential to reach earlier lines of treatment.
SVB Securities analysts on Tuesday called the $500 million announcement “the extreme side of cGMP facility expenses,” noting that the expansion will help them
reach scale for their earlier line trials, citing anticipated approval for cilta-cel in the 2L+ setting (based on CARTITUDE-4) as the proposed deadline for the build-out. With this build-out, Legend plans to double their approved treatment centers to 70-80 centers.
Carvykti stole the show at ASCO 2017 when Legend CSO Frank Fan and his team reported an impressive 100% overall response rate among multiple myeloma patients. That was enough for Janssen to jump in with a $350 million cash deal to partner on the big cancer candidate.
SVB Securities added, while estimating a launch date for BMS and 2seventy’s Abecma (ide-cel) in third to fifth line multiple myeloma in the first half of 2023, on the manufacturing front:
Neither 2seventy / BMY or Legend / JNJ have guided COGS expectations for BCMA CAR-T in the long term. 2seventy management has guided that ide-cel will be profitable towards the end of 2022 or early 2023, as they scale more doses on the base infrastructure. We assume program profitability for ide-cel in 1Q23 and then COGS ramp-down, with increased ide-cel manufacturing scale. For us, the speed and extent of operational efficiencies are highly uncertain.
