Manufacturing success rate holds back sales of Bristol Myers’ CD19 CAR-T cell therapy

By Nick Taylor

- Last updated on GMT

Pic:getty/jonathankitchen
Pic:getty/jonathankitchen

Related tags: Bristol Myers Squibb, CAR-T, Cell therapy

Lower-than-expected manufacturing success rates constrained sales of Bristol Myers Squibb’s CAR-T cell therapy Breyanzi in the second quarter.

In the first quarter, Bristol Myers reported Breyanzi sales of $44m. The company failed to kick on from that position in the next quarter, when revenues slipped sequentially to $39m amid production problems that prevented it from converting all the demand into revenues.

Talking to investors on a second quarter result conference call on July 27, Chris Boerner, chief commercial officer at Bristol Myers, set out what went wrong and why the company believes the problems have now been resolved.

We had underlying demand that was very strong. We're obviously very pleased with the second-line approval and the fact that it's given us the broadest label of any CAR T in [diffuse large B-cell lymphoma]. But ... sales were impacted in the quarter by manufacturing success rates. Those success rates, the issue underlying that was resolved, and we expect success rates to improve as we head into this quarter​,” said Boerner.

The resolution of the cause of the low Breyanzi manufacturing success rate clears one of the headwinds that stopped Bristol Myers from maximizing sales of the CD19 CAR-T cell therapy in the second quarter. Another constraint on growth remains, though.

Bristol Myers aimed to have capacity ready for the launch of Breyanzi in second-line patients around the middle of the year. However, the target for bringing the additional capacity online has now slipped into 2023.

Given the broader label, we had obviously hoped to have increased capacity in the second half of this year. We're now anticipating that in Q1 of 2023. Delivering that capacity is a top priority. The focus here is on increasing both vector and drug product supply​,” said Boerner.

Boerner said “slot availability is going to be critical​” for Breyanzi because of its label and profile. Having successfully increased capacity for the anti-BCMA CAR-T cell therapy Abecma, the executive is confident the same focus can deliver positive results for the production of Breyanzi.

Bristol Myers is working to increase Breyanzi capacity at its existing facilities and to bring new sites in the Netherlands and Massachusetts online. The expansions are accompanied by work to improve turnaround times and vector supply.

Related topics: Upstream Processing

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