So far, Gilead Sciences’ Kite Pharma has been buying from contractors the viral vector material needed for its chimeric antigen receptor T-cell (CAR-T) treatment Yescarta. But with an expanding pipeline of cell therapies, the company says it is time to be able to produce its own.
The drugmaker announced today that it will build a 67,000-square-foot facility at its Oceanside, California, biologics site just for developing viral vectors, the tools needed to deliver genetic material into cells. The company declined to disclose what it expects to invest in the facility or how many people it may employ but said it is slated to begin commercial manufacturing of viral vectors in the second half of 2021.
“Viral vectors are one of the key components in cell therapy production, however, the industry’s current development and manufacturing capabilities are not widely established and supply is limited,” Tim Moore, executive vice president of technical operations for Kite, said in a statement.
“By pursuing our own viral vector facility, we will be able to advance viral vector development and supply to allow for accelerated process development of current CAR T and future pipeline therapies, while continuing to partner with external suppliers,” Moore explained.
Gilead swept up Kite and Yescarta in a $12 billion deal in 2017. Approved for treating some patients with large B-cell lymphoma, Gilead has had trouble getting Yescarta established in the market. It generated $264 million last year but has trailed Novartis’ Kymriah, which won the first-ever cell therapy approval.
Still, Gilead is planning for a big future in cell therapies and has aggressively expanded its manufacturing capabilities to stay ahead of the curve.
In April, it announced it was building a 279,000-square-foot facility west of Baltimore in Frederick County, Maryland, to manufacture its next-gen oncology treatments including Yescarta and its prospective T-cell receptor therapies. The site will employ up to 800 workers.
The big biotech also is building a separate CAR-T manufacturing facility near an Amsterdam airport, a move that is designed to shorten shipping times in Europe for the sensitive product. It also acquired a new building in Santa Monica, California, from Astellas Pharma that it will use for clinical manufacturing and cell therapy R&D.
In addition, Gilead is muscling up its executive infrastructure to make its big move into the new market. Last week, it announced it will bring on Eli Lilly executive Christi Shaw to run Kite and move the effort forward, and last year the company nabbed Michael Amoroso from Eisai to be its SVP and head of worldwide commercial efforts in cell therapy. He oversees sales and marketing, doctor and patient services and “market access”—aka payer negotiations.
While Gilead has touted Kite’s cell therapy pipeline, it has had troubles there as well. Earlier this year Gilead dumped an anti-BCMA cell therapy for multiple myeloma that was part of its $12 billion acquisition of Kite and then took an $820 million impairment charge in the quarter.
Jul 16, 2019