The payout of a contingent value right linked to the acquisition of Celgene by Bristol Myers Squibb was already looking like a long shot. Now the chances of it bearing fruit look even slimmer, after the Pdufa date for liso-cel came and went yesterday without approval from the FDA. It could have been worse: liso-cel did not receive a complete response letter, so optimistic investors can cling to the hope that the asset might still get the go-ahead by December 31 – the date needed to meet the conditions of the CVR. The FDA delayed making a decision because its staff have been unable to inspect a Texas manufacturing facility, due to Covid-19 travel restrictions – a situation that seems unlikely to improve any time soon. Bristol gave no indication of whether an inspection has been scheduled, in a press release. Even if liso-cel does get the nod by the end of the year, another Car-T project, ide-cel, must also be approved by March 31, 2021, just four days after its Pdufa date – not leaving much room for manoeuvre. The tradable CVR, which could be worth $9 if all three milestones are met, plunged as much as 25% this morning to $1.05.
|The Bristol Myers Squibb/Celgene CVR|
|Ozanimod||Approval by 31 Dec 2020||Approved|
|Liso-cel||Approval by 31 Dec 2020||BLA filed; Pdufa date initially 17 Aug, new date of 16 Nov missed|
|Ide-cel||Approval by 31 Mar 2021||BLA filed, RTF letter; refiled 22 Sep 2020; Pdufa date 27 Mar 2021|
|*Each CVR pays out $9 only if all three events are met.|