Novartis’s $90 million Swiss manufacturing facility to assist clear up cell remedy bottleneck .
ZURICH (Reuters) – Swiss drugmaker Novartis’s (NOVN.S) new $90 million cell and gene remedy manufacturing facility in northern Switzerland is on monitor to start business manufacturing of its cell remedy Kymriah for most cancers in 2020.
The corporate’s emblem is seen on the new cell and gene remedy manufacturing facility of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann
The brand new manufacturing facility, anticipated to make use of 450 folks, will permit the drugmaker to make its Kymriah therapy for European sufferers with out first having to fly their immune cells throughout the Atlantic Ocean.
The Swiss manufacturing facility, in addition to a separate French web site additionally being expanded, are central to Novartis’s plans to rework Kymriah from a modest $250 million-per-year vendor right into a $1 billion blockbuster as European demand rises.
“We have already started to produce clinical batches at both sites and are on track to begin producing commercial product in 2020,” Novartis stated.
Basel-based Novartis sees cell and gene therapies finally contributing about 15% of its income.(nL8N2874FU)(nL5N25V4JJ)
T cells presently harvested from Europeans getting the $400,000-per-patient Kymriah blood most cancers remedy should now be despatched to a U.S. laboratory for re-engineering. Analysts have referred to as the shortage of producing capability a “major bottleneck”.
Novartis is investing some $500 million in new amenities around the globe to handle manufacturing bottlenecks and drug corporations together with Novartis, Pfizer (PFE.N) and others, have plans to spend $2 billion constructing out gene and cell remedy manufacturing after speedy growth into these remedies.
Kymriah’s international rollout in 20 nations, plus Novartis’s efforts to broaden the remedy’s indications, make including business manufacturing a precedence, together with in China and Japan. (nL8N1WD64W)
Kymriah’s 2018 approval was hailed as a breakthrough as a last-ditch therapy for acute lymphoblastic leukemia and diffuse massive B-cell lymphoma. T-cells are extracted from sufferers, modified to assault their most cancers, then re-infused within the hope they work the place different remedies failed.
However its advanced manufacturing, tailored for every affected person, poses logistical challenges in comparison with off-the-shelf remedies, particularly in Europe the place Novartis lacked business manufacturing.
“The key factor in bringing local manufacturing to each region is to make Kymriah available as quickly as possible,” Novartis stated.
(This story removes reference to Zolgensma, which is not going to be made at new Swiss manufacturing facility in 2020.)
Reporting by John Miller; Modifying by Elaine Hardcastle