Feeling the pressure, Bristol Myers pushes back timeline for production of Breyanzi

Bristol Myers Squibb's promising CAR-T treatment Breyanzi made another disappointing showing as the New York pharma reported second-quarter earnings Wednesday. 

In the fifth full quarter since it was approved as a third-line treatment for relapsed or refractory B-cell lymphoma, Breyanzi generated just $39 million in sales, down from $44 million (PDF) the previous period.

What’s causing the stagnation of this groundbreaking therapy? Manufacturing issues.

A month ago, when Breyanzi won a coveted FDA approval for use as a second-line treatment in B-cell lymphoma, BMS said production capacity could be increased in the second half of this year. But Wednesday, BMS said the timeline has been pushed back further.

“Given the broader label, we had hoped to have increased capacity in the second half of this year,” Chris Boerner, Ph.D., BMS’ chief commercial officer, said during the earnings conference call. “We’re now anticipating that in Q1 of 2023.”

Boerner said the company is focused on increasing both vector and drug product supply. BMS has had somewhat more success with the production of another CAR-T, multiple myeloma treatment Abecma, which generated sales of $89 million in the second quarter, up from $67 million in the previous period.

But “demand (for Abecma) continues to outpace supply,” said BMS Chief Financial Officer David Elkins, who added that the company is looking to add more manufacturing sites in the future, beyond a pair due to come online in Devens, Massachusetts, and Leiden, Netherlands.  

“We’ve seen a nice increase in the capacity for Abecma,” Boerner said. “And we anticipate that that same focus will now be applied to Breyanzi.”

Manufacturing issues with Breyanzi predate its approval. When the treatment—which was acquired in BMS’s $74 billion buyout of Celgene—didn’t gain approval before the end of 2020 because of an inspection delay, it negated a $6.4 billion contingent value right payout and triggered an investor lawsuit. A month ago, BMS lost its bid to have the suit dismissed.

Now, the pressure is on BMS to solve its production issues and ramp up supply.

“That capacity is gonna be important because given the broad label with this product and the compelling profile, slot availability is going to be critical,” Boerner said.