Swiss drug producer, Novartis’s new $90 million cell and gene therapy plant in northern Switzerland, is on track to start commercial production of its cell therapy Kymriah for cancer next year.
The new plant, anticipated to employ 450 people, will enable the drugmaker to make its Kymriah therapy for European patients without first having to fly their immune cells across the Atlantic Ocean.
The Swiss plant, in addition to a separate French site further being expanded, is central to Novartis’s plans to transform Kymriah from a simple $250 million-per-year vendor into a $1 billion blockbuster as European demand increases.
T cells currently harvested from Europeans getting the $400,000-per-patient Kymriah blood cancer therapy should now be sent to a U.S. laboratory for re-engineering. Analysts have called the shortage of manufacturing capability a “main bottleneck”.
Novartis is investing around $500 million in new amenities all over the world to handle production bottlenecks, and drug firms, including Novartis, Pfizer, and others, have plans to spend $2 billion building out a gene and cell therapy manufacturing after accelerated growth into these therapies.
Kymriah’s global launch in 20 nations, plus Novartis’s efforts to expand the therapy’s indications, make adding industrial production a priority, also in China and Japan.
Kymriah’s 2018 license was hailed as a breakthrough as a last-ditch therapy for acute lymphoblastic leukemia and diffuse large B-cell lymphoma. T-cells are extracted from patients, altered to assault their cancer, then re-infused in the hope they work where different therapies failed.
However, its complex production, tailored for each sufferer, poses logistical difficulties compared to off-the-shelf remedies, especially in Europe, where Novartis lacked commercial production.