Novartis on CAR T division: ‘Reintegrated but still committed’

By Staff Reporter

- Last updated on GMT

Image: iStock/in.focus
Image: iStock/in.focus

Related tags Acute lymphoblastic leukemia

The cell and gene therapy unit back will be reintegrated into the main business Novartis says, denying it has turned its back on CAR T therapies.

A statement sent to media organisations this week announced the Swiss pharma firm’s decision to disband its standalone CAR T therapy unit, and take re-incorporate it into the larger Novartis organization.

The decision was made “as part of a natural evolution of our internal organizational design,”​ the firm said.

“An isolated Unit worked well under our prior Pharma Division structure, but with a new integrated development model, we can efficiently advance our work on CAR T as part of our focus in immuno-oncology by reintegrating the functions.”

The firm’s lead product is CTL019, an autologous cell therapy in trials for relapsed/refractory (r/r) pediatric acute lymphoblastic leukemia, and despite the restructure Novartis said it “is committed to the ongoing development”​ of this, and its other of CAR T therapies.

“This organizational change will not impact the plan to file CTL019 in pediatric r/r ALL with the US FDA in early 2017 and with EMA later in 2017.”

Over the past few years, Novartis has invested heavily in the cell and gene therapy unit, buying Dendreon’s Provenge plant in New Jersey in late 2012​, constructing a $20m R&D centre at the University of Pennsylvania in 2014​, and paying $35m for a stake in stem cell expansion tech firm Gamida Cell the same year​.

While “most associates who were previously dedicated to cell & gene therapies will now be redeployed to areas where they will share their knowledge”​ in the immunotherapy space, around 120 positions will be lost.

‘Potholes’ on the cell & gene pathway

The burgeoning cell and gene therapy space received a blow in July​ when Juno Therapeutics had to place a clinical trial of its candidate JCAR015 on hold following the death of two patients. And with Novartis’ announcement, some commentators are beginning to question the sustainability of the sector.

While the news “appears to remove a leading and powerful competitor moving forward,” ​it “perhaps negatively signals that there are significant challenges and questions outstanding and scaling back is prudent until these issues are resolved,” ​Piper Jaffrey analyst Joshua Schimmer said in a note.

Meanwhile Mizuho Securities’ analyst Eric Criscuol described these events as “potholes”​ as part of “an exciting long-term opportunity.”

Related topics Bio Developments Pipelines

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