Novartis has offered to buy a cell and gene therapy manufacturer in an ongoing effort to unclog a commercial rollout for its pioneering CAR-T therapy Kymriah that’s been slowed down by manufacturing woes.
Set to become a wholly owned Novartis facility, CellforCure first signed an agreement to produce Kymriah in July 2018. With the tech transfer complete, the clinical supply production is expected to begin by mid-2019 — when the deal is expected to close.
The CDMO is based in Les Ulis near Paris, operating what it describes as one of the first and largest platforms in Europe for cell and gene therapy.
Variability in product specifications has hampered Novartis’ ability to meet demand for an incredibly complex treatment — which involves extracting T cells from patients, modifying them and then infusing patients with a therapeutic punch — and a revolving door at the cell manufacturing chief’s office didn’t help.
In August, when Novartis scored a key marketing approval from the European Commission, it also unveiled plans to invest €78.8 million into their cell and gene therapy manufacturing operations in Switzerland. It also has an alliance in place with the Fraunhofer Institute in Germany to support clinical trials and post-approval manufacturing.
Liz Barrett, who’s stepping down as oncology chief, previously also told Pharmaphorum that Novartis was looking to move manufacturing facilities closer to the clinics where patients are treated to speed up the process.
It’s all part of a toe-to-toe fight with Gilead and Kite Pharma, which have a bespoke manufacturing site for Yescarta.
“If completed, this acquisition also would potentially increase manufacturing capacity for other cell and gene therapies in the Novartis pipeline,” Steffen Lang, Novartis’ global head of technical operations, added in a statement.
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