Kite gets freedom to fly after separation from Gilead

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/AleksanderKrol)
(Image: Getty/AleksanderKrol)

Related tags: Gilead, Kite, CAR-T, Cell therapy manufacturing, Cell therapy, Yescarta

Gilead’s new CEO unties Kite as an independent business unit to give Yescarta’s manufacturer more autonomy in the biotech sky.

During a first-quarter earnings conference call, Daniel O’Day, former Roche Pharmaceuticals CEO who took Gilead’s helm in March, announced the plan to separate Kite Pharma, which Gilead acquired in 2017​ for $11,9bn (€10.6bn).

Kite focuses on chimeric antigen receptor (CAR)-T cell therapies manufacturing and currently markets Yescarta​ (axicabtagene ciloleucel), one of the two CAR-T cell therapies approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).  

The separation had been announced internally at the end of March. Gilead has initiated a search for a new CEO of Kite, who will be reporting to O’Day and “will have full accountability for all aspects of cell therapy,”​ O’Day said.

Gilead’s CEO said that providing Kite with autonomy will foster agility, innovation and entrepreneurialism and added that the decision for the separation was made “for the reasons of focus.”

“Kite itself in cell therapy oncology is an ultra-competitive area. I think we have a leadership position, but I think we need to maintain that leadership position,”​ he noted and added that Kite as an independent business unit “will wake up and go to sleep every day thinking about how to be the leaders in oncology cell therapy.”

According to O’Day, “cell therapy is a critical piece of the puzzle with regards to the long-term future of oncology and a critical element of Gilead's long-term strategy, helping us to build on a legacy of transformational medicines.”

“Let's make sure we win in cell therapy and leverage the remaining parts of the Gilead focus on oncology to win in the broader oncology market as well,” ​he said.

The company’s CFO, Robin Washington, announced $5.2bn (€4.64bn) product sales during the first quarter, a 4% increase from the same period of 2018 and down 8% sequentially.

Gilead recently expanded Kite’s manufacturing capability with a new 20-acre facility​ in Maryland, in which the commercial production is expected to begin by late 2021.  

Dominique Tonelli, head of medical affairs in Europe for Kite recently revealed to us​ that the company’s is producing 97% of Yescarta treatments to specification, placing the company one step ahead of Novartis, which has previously faced difficulties​ in effectively manufacturing its CAR-T cell therapy Kymriah (tisagenlecleucel).

Laura Hamill, executive vice president of worldwide commercial operations for Gilead, said Yescarta’s worldwide sales were $93m (€83m) during the first quarter, up 90% quarter-over-quarter. Since launched, more than 1,500 patients have been treated with Yescarta in the US and Europe.

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