Like all drugmakers with CAR-T cell therapies on the market, Gilead Sciences has had its fair share of roadblocks to commercial success—not the least of which has been a difficult manufacturing scale-up. Now, Gilead could be ready to take CAR-T therapy Yescarta to the next level with a long-awaited European production hub.
After years in the works, Gilead's 117,000-square-foot CAR-T facility at SEGRO Park Amsterdam Airport is now fully operational after the European Medicines Agency (EMA) approved the plant's end-to-end manufacturing process late last week.
The facility, operated by Gilead's Kite unit, will house European production for cell therapy Yescarta, which won an EMA approval back in August 2018 to treat relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.
Yescarta received its initial FDA approval in October 2017, just two months after Novartis' Kymriah broke ground as the first CAR-T therapy approved for U.S. patients. The one-time therapy came with a lofty price tag of $375,000 per patient.
With an EMA nod in hand, Gilead forecasts the Amsterdam facility will be able to churn out enough of the pricey therapy for 4,000 patients each year. The plant's placement at the Amsterdam airport will allow Gilead to streamline the complicated manufacturing process for Yescarta and help supply the drugmaker's 90 qualified treatment centers across 15 European countries and Israel.
"This facility will benefit both patients and healthcare professionals, allowing Yescarta to reach European treatment centers more quickly and reducing the time it takes to reach patients by almost a week," Kite CEO Christi Shaw said in a release.
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Gilead announced its intent to lease space in Amsterdam to use as Yescarta's European hub back in May 2018, saying the site would eventually employ 300.
CAR-T therapies use a notoriously complicated manufacturing process that involves shipping samples of a patients' blood for personalized T-cell reprogramming then shipping the product back to a treatment center for infusion.
Placing the facility at Amsterdam's airport will ease travel times for European patients—whose blood previously was flown across the Atlantic to Gilead's U.S. manufacturing sites—and also cut logistical hurdles in shipping it to offsite facilities.
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In an effort to overcome those manufacturing hurdles, Gilead has made big investments in its CAR-T manufacturing capacity in recent years.
Most recently, the drugmaker announced it would 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.
Gilead also has big plans to expand its U.S. CAR-T manufacturing. In April 2019, Gilead laid out plans for a 279,000-square-foot facility on 20 acres in Frederick County in Maryland, roughly 20 miles west of Baltimore. The site will expand Kite’s ability to manufacture its next-gen oncology treatments, including Yescarta and its prospective T-cell receptor therapies.
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Despite the big investment, Yescarta and its $140 million in first-quarter sales hasn't proven itself a big winner for Gilead after a controversial $12 billion Kite Pharma acquisition in 2017.
In fourth-quarter 2019, Gilead took an $800 million write-down on Kite after a setback in indolent non-Hodgkin lymphoma. That followed an $820 million write-down in late 2018 last year related to Kite’s multiple myeloma candidate KITE-585.
Meanwhile, Gilead is on the hook for $1.2 billion in damages tied to a California verdict in April that Gilead and Kite "copied and commercialized" research that was used to score Yescarta's FDA approval.
The verdict, favoring Bristol Myers Squibb's Juno Therapeutics unit, included a $585 million up-front payment, plus $193 million in royalties based on Yescarta sales through Dec. 12. Judge Philip Gutierrez also ordered Kite to pay $32.8 million in pre-judgment interest and “enhanced damages” of more than $389 million, taking the total to about $1.2 billion.
Gilead said at the time it planned to appeal the verdict.