Brief

Kite inks China, Japan deals ahead of possible CAR-T drug approval

Dive Brief:

  • A leader in the CAR-T space, Kite announced on Tuesday a joint venture with Shanghai Fosun Pharmaceutical to create and commercialize KTE-C19 (axicabtagene ciloleucel) in China. A day prior, the biotech inked a deal with Daiichi Sankyo that would give it the same rights in Japan.
  • Fosun will hand over $40 million upfront to Kite, plus a potential $35 million in milestones payments and mid-single digit sales royalties. Daiichi Sankyo, meanwhile, is paying $50 million upfront, $20 million for clinical and manufacturing operations and offering an additional $200 million in milestones and low- to mid-double digit sales royalties. 
  • In the joint venture with Fosun, the Japanese company will get 50% ownership of the newly formed company and 60% of profits, while Kite will receive the complementary 50% and 40%, respectively. The new business will tentatively be named Fosun Pharma Kite Biotechnology Co.

Dive Insight:

As Kite Pharma begins filing the approval application for its lead candidate, the biotech is directing its focus to pharmaceutical markets — and took big steps into two of the world's largest this week. 

The deals continue a recent wave of good news for Kite and give the biotech a foothold in China and Japan, the world's second and third largest pharmaceutical markets. China's medication market, for instance, is poised to grow to $167 billion by 2020, according to figures cited by the U.S. Department of Commerce. The country also has a large cancer population, with 4.3 million new cancer cases in 2015 alone.

"This joint venture allows us to access a critically important market and meet a major objective of expanding our global reach," Kite's CEO Arie Belldegrun said in a Jan. 10 statement on its deal with Fosun. "Fosun Pharma is an innovator and market-maker, which makes them an ideal partner to develop and commercialize axicabtagene ciloleucel in China."

The move also extends Kite's lead over rival Juno Therapeutics, which hit a big setback after multiple patient deaths in clinical trials, and buttresses the biotech as it prepares to go toe-to-toe with Novartis. The Swiss biopharma expects to file its own CAR-T therapy for approval early this year.

As a CAR-T drug, KTE-C19 works with the body's immune system, using it as a tool to fight cancer.

Kite is pitting the drug against a number of different leukemias and lymphomas, and in December revealed positive results from the pivotal Phase 2 portion of its ZUMA-1 study, which tested the treatment in patients with diffuse large b-cell, primary mediastinal b-cell and transformed follicular lymphomas.

The company expects to complete a rolling submission of KTE-C19's Biologics License Application with the Food and Drug Administration before the end of March.

In addition to KTE-C19, Fosun now holds the ability to license two other Kite candidates: KITE-718 and KITE-439. Both drugs are in pre-Investigational New Drug (IND) development, though the former targets solid tumors and the latter aims to treat cervical, head and neck cancer. 

For a limited time, Daiichi Sankyo can also license Kite's other products, including KITE-718, that get an IND application filing in the next three years. In its statement, Kite did not provide additional information about what other products Daiichi Sankyo could license or any specifics about the licensing option period. 

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Filed Under: Mergers and Acquisitions / Deals Manufacturing