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Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time

Manufacturing Inspection Delays Could Impact Decision Due 27 March

 
• By Mandy Jackson

In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.

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Celgene shareholders get a payout from BMS if ide-cel and two other drugs are approved by specific deadlines • Source: Shutterstock

Bristol-Myers Squibb Company and bluebird bio have managed to get their B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor T-cell (CAR-T) therapy idecabtagene vicleucel in to the US Food and Drug Administration with a fighting chance at making the deadline for a contingent value right (CVR) payout that Bristol owes Celgene Corporation shareholders under the companies’ 2019 merger agreement.

Bristol and bluebird announced 22 September that the FDA accepted their biologic license application (BLA) for idecabtagene vicleucel (ide-cel, formerly...

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