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Novartis buys CellforCure to bolster cell, gene therapy

Move would make existing partner an in-house capability

Novartis

As capacity constraints hold back its first CAR-T Kymriah, Novartis has bought a French contract manufacturer to shore up its manufacturing muscle for cell and gene therapies.

The Swiss pharma giant has offered to buy CellforCure – which already has a contact to manufacture Kymriah (tisagenlecleucel) – from biotechnology group LFB for an undisclosed amount. It says the deal would “would bolster CAR-T cell therapy manufacturing capacity with potential to expand to other cell and gene therapies in Novartis pipeline.”

CellforCure recently completed the technology transfer process to ramp up Kymriah production and is due to start commercial manufacturing operations at its 38,000 sq. m. plant in Les Ulis next year.

Kymriah was approved by the EMA in August to treat people aged under 25 with relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL) and adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Novartis said at the time of Kymriah’s approval that it would only be supplying the CAR-T for children with ALL in the first instance because of capacity issues which have plagued the product since its US launch last year. It has reportedly been struggling with variability in product specifications that in some cases have led to manufacturing failures.

Those constraints have pegged back sales growth for the new product, which brought in just $20m in the third quarter of the year. CAR-Ts like Kymriah are challenging to produce, as they require harvesting T cells from patients, and then modifying and growing them outside the body so that they recognise and attack malignant cell when re-infused.

Under the terms of the deal, CellforCure will become a wholly-owned Novartis subsidiary, operating alongside the company’s production units for cell and gene therapies in Morris Plains, New Jersey, and a new $90m build in Stein, Switzerland, that will employ around 450 workers and is due to start operating in 2021.

Novartis has also negotiated a supply deal with Chinese contract manufacturer Cellular Biomedicines and has been looking to sign up another partner for the Japanese market. It also has a longstanding arrangement with the Fraunhofer Institute in Germany to produce Kymriah for clinical trials.

Steffen Lang

Steffen Lang

“If completed, this acquisition also would potentially increase manufacturing capacity for other cell and gene therapies in the Novartis pipeline,” said the company’s global head of technical operations Steffen Lang.

Article by
Phil Taylor

21st December 2018

From: Sales

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