Here is an interesting story about how low a BP (Bristol-Myers Squibb in this case) would stoop to make/save money. Innocent until proven guilty, but the story certainly has some compelling details. Also shows the difficulty of negotiating with BP. Excerpts and link below.
Unidentified witnesses accuse Bristol Myers of scuttling timely FDA move on liso-cel to avoid $6.4B payout
Back in June, disgruntled Celgene shareholders filed a lawsuit against Bristol Myers Squibb, accusing the pharma giant of purposely slow-rolling Breyanzi’s approval to avoid making a $6.4 billion contingent value rights (CVR) payout tied to its big Celgene acquisition.
Now, eight unidentified witnesses are coming forth to detail “a series of deliberate or reckless acts” they say BMS took to slam the brakes on what they say could have been an otherwise swift approval for Breyanzi.
“Despite its entitlement to expedited review, Bristol successfully delayed the FDA’s regulatory approval of Liso-cel for just enough time to avoid the $6.4 billion CVR payout to investors through a series of deliberate or reckless acts that it falsely passed off as unforeseeable mistakes or as events out of its control,” a new complaint states, filed on Tuesday.
Upon discussing a potential BMS takeover, Celgene proposed structuring the CVR agreement to provide separate payouts based on FDA approval of each of the company’s five late-stage assets. But BMS “flatly refused” that structure, according to the complaint, stating it was “unwilling to pay any amount under a CVR agreement unless all milestones were achieved” before the specified dates.
They put $6.4 billion into a CVR that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date. Breyanzi — liso-cel — had a deadline of December 31, 2020.
They didn’t make the deadline on Breyanzi, and the CVR became worthless.
Celgene had repeatedly stated — even after announcing the merger — that Breyanzi was on track for a BLA submission in the second half of 2019, with an approval expected in mid-2020. Celgene submitted the first component of its BLA in September 2019, and the FDA found no issues with that portion, according to the complaint. However, BMS took three months to submit the next portion (CMC), and the FDA later stated that it found “significant additional omissions” in BMS’ BLA.
The complaint alleges that BMS left out “volumes of basic information,” including omissions that were “glaringly obvious, particularly for a drug company of Bristol’s sophistication and experience, and would have needed to be approved by Bristol senior executives.”
Regulators also found “a litany of basic and easily avoidable deficiencies at both of the facilities where Liso-cel was being manufactured,” the complaint argues. Addressing these manufacturing deficiencies required supplemental regulatory submissions from BMS, but those submissions were also deficient and required further supplementation, the plaintiffs allege.
At one point, the FDA concluded that new information provided by BMS was so substantial that it required a major amendment, which one witness (a former executive director at BMS) called a “major blunder.”
Breyanzi ended up securing approval just 36 days past the milestone date. The drug raked in $87 million last year, according to BMS’ Q4 results.
“This unprecedented string of deficiencies in the Liso-cel approval process pushed FDA approval 36 days beyond the Milestone date, just long enough to spare Bristol a $6.4 billion payout to CVR holders, while allowing it to reap the economic benefits of bringing the lucrative drug to market after a modest delay,” the complaint states.
https://endpts.com/unidentified-witnesses-acc...4b-payout/
Unidentified witnesses accuse Bristol Myers of scuttling timely FDA move on liso-cel to avoid $6.4B payout
Back in June, disgruntled Celgene shareholders filed a lawsuit against Bristol Myers Squibb, accusing the pharma giant of purposely slow-rolling Breyanzi’s approval to avoid making a $6.4 billion contingent value rights (CVR) payout tied to its big Celgene acquisition.
Now, eight unidentified witnesses are coming forth to detail “a series of deliberate or reckless acts” they say BMS took to slam the brakes on what they say could have been an otherwise swift approval for Breyanzi.
“Despite its entitlement to expedited review, Bristol successfully delayed the FDA’s regulatory approval of Liso-cel for just enough time to avoid the $6.4 billion CVR payout to investors through a series of deliberate or reckless acts that it falsely passed off as unforeseeable mistakes or as events out of its control,” a new complaint states, filed on Tuesday.
Upon discussing a potential BMS takeover, Celgene proposed structuring the CVR agreement to provide separate payouts based on FDA approval of each of the company’s five late-stage assets. But BMS “flatly refused” that structure, according to the complaint, stating it was “unwilling to pay any amount under a CVR agreement unless all milestones were achieved” before the specified dates.
They put $6.4 billion into a CVR that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date. Breyanzi — liso-cel — had a deadline of December 31, 2020.
They didn’t make the deadline on Breyanzi, and the CVR became worthless.
Celgene had repeatedly stated — even after announcing the merger — that Breyanzi was on track for a BLA submission in the second half of 2019, with an approval expected in mid-2020. Celgene submitted the first component of its BLA in September 2019, and the FDA found no issues with that portion, according to the complaint. However, BMS took three months to submit the next portion (CMC), and the FDA later stated that it found “significant additional omissions” in BMS’ BLA.
The complaint alleges that BMS left out “volumes of basic information,” including omissions that were “glaringly obvious, particularly for a drug company of Bristol’s sophistication and experience, and would have needed to be approved by Bristol senior executives.”
Regulators also found “a litany of basic and easily avoidable deficiencies at both of the facilities where Liso-cel was being manufactured,” the complaint argues. Addressing these manufacturing deficiencies required supplemental regulatory submissions from BMS, but those submissions were also deficient and required further supplementation, the plaintiffs allege.
At one point, the FDA concluded that new information provided by BMS was so substantial that it required a major amendment, which one witness (a former executive director at BMS) called a “major blunder.”
Breyanzi ended up securing approval just 36 days past the milestone date. The drug raked in $87 million last year, according to BMS’ Q4 results.
“This unprecedented string of deficiencies in the Liso-cel approval process pushed FDA approval 36 days beyond the Milestone date, just long enough to spare Bristol a $6.4 billion payout to CVR holders, while allowing it to reap the economic benefits of bringing the lucrative drug to market after a modest delay,” the complaint states.
https://endpts.com/unidentified-witnesses-acc...4b-payout/
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