With the approval in Europe of its CAR-T cancer drug Kymriah, Novartis figures demand will call for more production. To crank that capacity up, the drugmaker will build a plant in Switzerland that eventually may employ 450 workers.
The Swiss drugmaker today said it will spend CHF90 million ($91.5 million) over three years on an existing building at a production site in Stein, Switzerland, to ensure speedy delivery in the EU of the specialized drug that requires an extensive process to genetically code a patient’s T cells to hunt and kill cancer cells.
In an email, a spokesperson said that Novartis expects to initially have 260 positions and create up to 450 new jobs by 2021.
"The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options," Liz Barrett, CEO of Novartis Oncology, said in the announcement. "Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before, remaining steadfast in our goal of reimagining cancer."
Novartis announced the expansion plans after the European Commission on Monday approved the drug to treat acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL).
Gilead Sciences' Yescarta, a head-to-head rival to Kymriah, also got an EU approval today for DLBCL and primary mediastinal B-cell lymphoma. Gilead recently announced that it's building a CAR-T manufacturing plant at the Amsterdam airport in an effort to cut down on logistics and manufacturing turnaround time. The center will have 300 employees when fully operational, expected in 2020.
Kymriah, a one-time treatment, is priced at $475,000 in the U.S but the Swiss drugmaker today didn’t indicate what it will cost in the EU. It said only that it is working with national health and reimbursement authorities on a “fair, value-based pricing approach that is sustainable for national healthcare systems.”
Novartis said it would launch Kymriah initially in the pediatric ALL indication, as it continues to ramp up capacity. Its availability in each country will depend on getting qualified treatment centers up and running.
Besides its plant in Morris Plains, New Jersey, to meet initial demand, the company also has a production agreement with the France-based CDMO CELLforCURE, and an alliance with Fraunhofer Institute which currently makes Kymriah for clinical trials. It said it is working on a technology transfer to a CDMO in Japan.
The process to make the potential cures requires that blood be taken from a patient, cryopreserved, shipped to a manufacturing facility, reprogrammed and manufactured in the lab, and then shipped back for infusion into the patient, all in the shortest time possible to try to outrun aggressive cancers. Novartis in the U.S. has had a target turnaround time for manufacturing of 22 days.
Last month, the drugmaker said that it had run into some manufacturing issues around its production for relapsed large B-cell lymphoma in New Jersey, explaining that problem revolved around cell variability when treating DLBCL, Barrett explained the label for commercial production is more stringent than in clinical trials for the percentage of viable cells and that production has been out of spec because that percentage has not been met at the more stringent commercial level.
While production was not interrupted, Barrett said Novartis was working closely with the FDA as it figures out how to resolve the issue.