With its new drug application for the pioneering CAR-T drug KTE-C19 in the final weeks from being completed and shipped to regulators in search of an accelerated approval, Kite Pharma $KITE has now lined up two partners to manage their prospective leap into two key Asian markets. Kite has pulled the wraps off a joint venture for China while inking a $250 million-plus deal to break into the Japanese market alongside Daiichi Sankyo.
Kite is taking a $50 million upfront and $200 million in milestones for the Japanese deal, while Daiichi Sankyo is reserving another $200 million in additional milestones for each new drug candidate that Kite takes to the FDA over the next three years. Royalties will range from the low to mid-double digit range.
The biotech has completed a deal to create a JV in China with Fosun Pharma, which is handing over $40 million upfront, $20 million for initial funding for clinical activities and manufacturing and a set of milestone payments for their CAR-T in a 50/50 deal.
The deal for Japan partners Kite with one of the biggest players in that country’s pharma industry, and one that is committed to building up the infrastructure to produce and market these individually tailored therapies, which extract T cells from patients and engineer them into attack weapons pointed at cancer cells.
“Daiichi Sankyo made a strategic decision to get into cell therapy,” says Helen Kim, Kite’s chief of business development. “The structure is a more traditional licensing agreement. We will provide technology transfer on the manufacturing. It’s their desire to do the manufacturing” in Japan.
“They’re very strong in oncology,” she added about Fosun. “They just have a huge presence” in China.
Kite’s been engaged in a race with Novartis for the first approval for a CAR-T therapy, while one-time rival Juno struggles with a lead program which has been linked to five patient deaths due to brain toxicity. These first CAR-Ts have been associated with cytokine release syndrome, but have also shown great promise in treating aggressive non-Hodgkin lymphoma, where Kite has been targeting its first approval.
Kite has a European subsidiary that plans to wrestle for an approval on the continent.
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