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Brystol Myers Squibb handling the Breyanzi Approval

The lawsuit against Bristol Myers Squibb over a scuttled Contingent Value Rights (CVR) dividend linked to its $74 billion Celgene merger is getting more specifics. BMS was sued by former Celgene shareholders in June, accusing the company of “blatant malpractice” in delaying the development of Breyanzi, a CAR-T lymphoma therapy. BMS had refused to comment at the time of the first filing. A number of unnamed witnesses have now come forward to explain how Bristol Myers messed up.

The plaintiffs’ lawyers outlined the drugmaker’s numerous options to correct the situation before it was too late in a recent document. If BMS had received FDA clearance for three new drugs—Zeposia, Breyanzi, and Abecma—by a specific deadline, it would have reimbursed former Celgene stockholders $6.4 billion. The CVR became useless when Breyanzi, also known as liso-cel, failed to make it across the FDA finish line by Dec. 31, 2020.

According to excerpts provided by Mizuho Securities, “multiple” former employees who worked at the drug’s manufacturing facilities confirmed that BMS “knew the facilities were inadequately prepared prior to the FDA inspection and failed to take necessary action to address numerous well-known, but relatively easily solvable issues that impacted the timing of the FDA’s approval of liso-cel.”

UMB Bank NA, based in Kansas City, took issue with BMS’ decision to withhold “essential and mandatory material in its initial filing” for Breyanzi, which it filed as a trustee for Celgene’s former shareholders last year. Bristol was also accused of failing to “take steps necessary to prepare” two production facilities for FDA inspections, according to the complaint.

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