Gilead finds new home in Europe for CAR-T manufacturing
- Gilead said Tuesday it has leased a nearly 120,000-square-foot site in the Netherlands to support manufacture of its cancer cell therapy Yescarta, which is currently awaiting a decision on approval by EU regulators.
- Gilead expects the facility, which is located in an industrial park just across a highway from Amsterdam Airport Schiphol, to be fully operational by 2020.
- By securing a base of manufacturing in Europe, Gilead should be better positioned to commercialize Yescarta if approved for sale in the EU later this year by the European Commission. CAR-T therapies like Yescarta are uniquely time-sensitive medicines, requiring the extraction, genetic engineering and subsequent reinfusion of immune cells into cancer patients within a short window of time.
Gilead's choice of location for its new cell therapy manufacturing hub is strategic. By setting up operations next to the Amsterdam airport, the biotech will be able to more easily receive patient cells and ship finished cell therapy product across Europe.
Amsterdam's airport is the third busiest in Europe, with more than 68 million passengers and nearly two million tons of cargo arriving and departing during 2017.
In that regard, the new Amsterdam facility is similarly sited to Gilead's manufacturing hub in El Segundo, California — located some 10 minutes away by car from Los Angeles International Airport.
Gilead acquired Yescarta in its $11.9 billion takeover of Kite Pharma last summer, which also gave it Kite's manufacturing and research facilities.
Logistics considerations are paramount for CAR-T, which has to account for both the viability of patient cells and the short window in which patients can be successfully treated. Gilead says it can turn around a dose of Yescarta (axicabtagene ciloleucel) from apheresis to reinfusion back into the patient in a little over two weeks.
Gilead filed Yescarta for EU approval in aggressive non-Hodgkin lymphoma last summer and expects to secure an OK by the third quarter. Yescarta is already cleared for a similar indication in the U.S. and earned a higher-than-expected $40 million in sales over the first three months of 2018.
In a May 15 statement, Gilead also disclosed that it has leased 26,000 square feet in Gaithersburg, Maryland, to support a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. The CRADA will focus on research into cell therapies targeting patient-specific tumor neoantigens, Gilead said.
Put together, Gilead appears to be laying a foundation for a greater research and commercial footprint in cell therapy — something that aligns with the goal of company leadership to transform the technology into a "cornerstone" of cancer therapy.
The build-out should also help Gilead stand toe-to-toe with rival Novartis, which markets its competing CAR-T therapy Kymriah (tisagenlecleucel) for both acute lymphoblastic leukemia and non-Hodgkin lymphoma. The Swiss pharma manufactures Kymriah at a site in Morris Plains, New Jersey, but also has set up its CAR-T manufacturing process at the Fraunhofer-Institut for cell therapy and immunology facility in Leipzig, Germany.
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