With today’s unexpected three-month delay to the US decision date for Bristol-Myers Squibb’s Car-T therapy liso-cel (JCAR017) the Celgene contingent value right remains in play – just. But the chances of a further delay remain unquantifiable without knowing what added information the US FDA requested, causing the action date to be put back to November 16. Still, this is no trifling procedural issue: Bristol today said the new data constituted a major amendment to the filing. It is not clear whether the agency has inspected liso-cel’s Bothell, Washington production plant, but it is clear that the project is more complex to manufacture than currently approved Car-T therapies (Holding a contingent value right in uncertain times, March 27, 2020). One risk was that the agency would demand a comparison of liso-cel’s efficacy versus Novartis’s Kymriah and Gilead’s Yescarta – both already approved in the lymphoma indication sought – but this represents a worst-case scenario. More information could be forthcoming at Bristol’s first-quarter call tomorrow, but for now the $9 CVR is changing hands for around $4. Little wonder: the cushion between the new action date and the deadline is now a mere 45 days.
|Will it pay out? The CVR's three-horse accumulator|
|Ozanimod||Approval by 31 Dec 2020||Approved|
|Liso-cel||Approval by 31 Dec 2020||BLA filed; Pdufa date initially 17 Aug, now delayed to 16 Nov 2020|
|Ide-cel||Approval by 31 Mar 2021||BLA filed 31 Mar 2020|
|*Each CVR pays out $9 only if all three events are met.|
This story has been corrected to reflect the status of ide-cel.