Critically ill patients with multiple myeloma will need to wait a lot longer for an experimental new cancer therapy from Bristol Myers Squibb (NYSE:BMY) and bluebird bio (NASDAQ:BLUE) than they had expected. The FDA has refused to file a new biologics license application that would have made idecabtagene vicleucel (ide-cel) available as a treatment for patients who have run out of options.
Ide-cel was one of three potential blockbusters in Celgene's late-stage pipeline that Bristol Meyers Squibb wasn't willing to pay for up front when it purchased the company. Instead, Bristol issued tradable contingent value right (CVR) shares (NYSE: BMY.RT) that it will redeem for $9 apiece in the event all three drug candidates earn FDA approval before predetermined dates. Unfortunately for their holders, the CVRs will expire without any payout if just one candidate fails to earn approval on time.
One of the three, ozanimod, met its deadline in March and is currently marketed to treat multiple sclerosis under the brand name Zeposia. Liso-cel is a CAR-T treatment similar to ide-cel that involves removing a patient's T-cells, then training them to recognize and attack cancer once they're reinfused into the bloodstream.
Cutting it close
Liso-cel needs to earn approval by Dec. 31, 2020, or the CVR shares expire without any payout. On May 6, 2020, the FDA extended its review of liso-cel by three months, which doesn't leave much room for error.
The milestone date for ide-cel is March 31, 2021, which is 322 days away. Theoretically, there's still time for the FDA to review a resubmitted biologics licensing application for ide-cel with the chemistry and manufacturing information the FDA didn't find in the first attempt. The odds of such a quick turnaround, though, are paper thin.