Novartis commits to CAR-T manufacturing in restructure of cell therapy work

Novartis

Novartis has decided to disband its cell and gene therapy unit that has done its initial CAR-T work, a move that means 120 of the 400 workers will be let go and the rest redeployed. But the Swiss drugmaker insists the program is still alive and that it is still committed to building out the intricate manufacturing processes necessary to producing a CAR-T treatment.

Novartis ($NVS) in a statement Wednesday confirmed a report in Endpoints that it had decided to “re-integrate activities conducted by the Cell & Gene Therapies Unit into the larger Novartis organization” as part of a new integrated development model that will be part of its focus in immuno-oncology. But the company insisted it remains “committed to the ongoing development of CART therapies” and the manufacturing element of that program.

“We are proud of the great strides we have made in manufacturing CART therapies,” Novartis said in its statement. It said it was confident that the manufacturing facility in Morris Plains, NJ, “has a strong foundation for implementing the CTL019 manufacturing process and future therapies.” It pointed out that it also has an agreement with the Fraunhofer Institute for Cell Therapy and Immunology cell processing of investigational, personalized T cell therapy CTL019 in Europe.

The CTL019 it refers to is Novartis’ CAR-T treatment that will first be offered for treating relapsed/refractory (r/r) pediatric acute lymphoblastic leukemia (ALL) patients, which early trials have shown to be quite effective in treating pediatric cases. It said it still expects to present its application for the treatment to the FDA and EMA in 2017.  

The personalized cell treatment has shown big promise, but the manufacturing element is complicated. One of the big questions for drugmakers is how they will cost effectively handle that side of it. CAR T cells are made by extracting immune system T cells from an individual patient and altering the DNA to equip them with targeting mechanisms called chimeric antigen receptors (CARs). The CARs seek out and bind to proteins expressed by cancer cells, and then the altered cells are infused back into the same patient. The process takes about two weeks.

In the U.S., Novartis is using a 173,000-square-foot plant in Morris Plains, NJ, that it acquired for $43 million in 2012 from Dendreon to handle clinical supplies, and expects to scale it up for commercial production. Dendreon had three plants for its personalized prostate cancer vaccine and their cost was one of the factors when it went into bankruptcy and its assets were bought by Valeant Pharma ($VRX). Its cost of goods at one point was 77%.

Novartis did not say whether any of the 120 employees who are being let go in the revamp are in manufacturing, only that the “approximately 120 positions across several different Novartis affiliates.”

Novartis says it believes it can make the manufacturing element of CAR-T therapies work. “We are leading an unprecedented journey to achieve large-scale manufacturing for a cell-based gene therapy and are working to achieve compliance with quality manufacturing standards set forth by health authorities,” it said in its statement. “We are creating a robust process that meets quality standards with proven success before the process can be fully optimized and further scaled.”

- here’s the Endpoints story

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