- Novartis has decided to break up its Cell & Gene Therapies unit, folding the formerly stand-alone group back into the larger company organization. A company spokesperson said the restructuring, first reported by Endpoints, will not affect the timeline for filing an application for approval of its most advanced CAR-T therapy, CTL019, with U.S. regulators.
- While Novartis depicted re-integration of the unit as part of the ongoing organizational reshuffling at the Swiss pharma, the decision still marks a notable shift in strategy for a company which has been considered a leader in CAR-T development.
- The changes will impact roughly 120 positions, some of which were vacant. More than 400 staff worked in the unit and the majority will be redeployed internally, the Novartis spokesperson confirmed.
Novartis has been going through a major transformation this year. The pharma giant announced in May it was rejiggering the structure of its entire pharma unit to place greater emphasis on oncology. As a result, Novartis broke out its oncology drug division from the greater pharmaceutical division and placed Bruno Strigini—former head of the oncology division—as CEO of the unit. At the same time, the head of the company's pharmaceutical division David Epstein left unceremoniously and was replaced by AstraZeneca's Paul Hudson.
While the restructuring seemed largely cosmetic at the time (it would not change the way financials were reported), the latest development is anything but superficial.
The changes announced in May organized the company into three consumer facing divisions: Innovative Medicines (both Novartis Pharmaceuticals and Novartis Oncology); Sandoz, the generics and biosimilars business; and Alcon, its eye-care division. With the reorganization, Novartis hopes to reestablish itself as a leader in oncology where it fallen behind in recent years as competitors developed immuno-therapies.
Interestingly enough, the gene and cell therapies unit, which is known for its work in immune therapies for hematologic cancers, will not be incorporated into the oncology division, but instead into the larger pharmaceutical division, according to the company spokesman.
The gene and cell therapies unit was only established at the end of 2013, about a year and a half after Novartis signed its groundbreaking collaboration with the University of Pennsylvania, which gave the company its CAR-T program.
Novartis has been at the forefront of the space, building out infrastructure and is set to file for approval of its first therapy in the space early next year. Novartis has commented the gene and cell therapies unit was a stand-out program that operated more like a biotech within a large pharma than a division.
Yet, there have been setbacks in the field in recent months that have raised questions about the safety of the CAR-T products, including Juno's clinical hold (lifted shortly thereafter). In a prior interview, Usman Azam, now former head of the gene and cell therapies unit, said expectations had been managed and that the company was moving forward in the space cautiously.