Gilead CAR-T cancer therapy capacity to quadruple by 2026

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By Michael Erman

FREDERICK, Maryland, March 15 (Reuters) - Gilead Sciences will be able to quadruple production of its cell therapy cancer treatments by 2026 due to improvements in the U.S. biotech's manufacturing processes, an executive in charge of that business told Reuters.

Cindy Perettie, executive vice president of Gilead's Kite cell therapy unit, said these changes have already allowed the company to increase the number of patient treatments it can produce to 10,000 annually from 6,000 last year.

"We expect by 2026, with the same footprint - not changing anything or investing - we will be at capacity for 24,000 CAR-Ts per year," Perettie said on Thursday in an interview at a company manufacturing facility in Frederick, Maryland.

Cell therapies like its chimeric antigen receptor T-cell (CAR-T) treatments Yescarta and Tecartus are increasingly important to Gilead, which has been working for several years to build its presence in oncology and diversify outside of its core HIV business.

Gilead recently announced it reduced its median turnaround time to produce Yescarta to 14 days. Perettie said she expects the company will be able to shorten the turnaround time further this year.

Gilead paid nearly $12 billion in 2017 to buy Kite, one of the leading players in the emerging field of CAR-T therapies, which currently treat a variety of blood cancers. The company has said it expects oncology products to account for a third of its revenue by the end of the decade.

CAR-T therapy involves removing a patients’ own T cells - a key component of the immune system - engineering them to recognize and attack malignant cells, and re-infusing them.

Gilead, whose rivals in the field include Johnson & Johnson , Bristol Myers Squibb and Novartis, is the market leader, according to Perettie.

She said the company expects to build its market share for Yescarta and Tecartus this year as it works to make the treatments available to more patients in more hospitals.

Gilead is expanding its network of health center sites across the U.S. where patients can receive the therapy, and "doubling down" on efforts to reach patients in its existing treatment sites in academic hospitals around the country, Perettie said.

Initial growth will come from those academic hospitals, she said, adding that most of the growth from efforts to expand into more hospitals will not be seen until 2025.

The company expects to build the overall reach of CAR-T in the U.S. as well as its market share. More than 27,000 doses of the six approved CAR-T products have been administered in the U.S. since 2017.

Gilead's CAR-T revenue growth slowed recently, with sales dipping sequentially in the fourth quarter of 2023 to around $456 million for both treatments. Yescarta and Tecartus each costs more than $420,000 in the United States.

The company said last month that it expects first-quarter CAR-T sales to be flat or slightly up from the prior quarter, but that growth would pick up later this year.

Earlier this week, researchers reported encouraging data from a small, ongoing study of a Gilead CAR-T therapy against recurrent glioblastoma, a deadly form a brain cancer. (Reporting by Michael Erman; editing by Caroline Humer and Bill Berkrot)

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