Postpone the approval of anti-cancer drugs!

Former Celgene shareholders took Bristol-Myers Squibb (BMS) to court
.

This Thursday, the complaint was filed in the U.

Bristol-Myers Squibb acquired Xinji for US$74 billion in November 2019.
According to one of the CVR agreements involving contingent rights, Bristol-Myers Squibb will need to pay Xinji’s former shareholders if three new drugs are approved by the FDA.
6.
4 billion US dollars of transactions, each product has a clear deadline for approval
.

However, former Xinji shareholders stated that one of the new CAR-T drugs, liso-cel, for the treatment of non-Hodgkin’s lymphoma, had not been approved by the FDA before December 31 last year, and the payment had disappeared out of thin air.
"Again
.

This CAR-T therapy, branded as Breyanzi, after a series of delays, the FDA's review target date far exceeded the initial target specified in the payment agreement

The lawsuit was filed by UMB Bank NA, headquartered in Kansas City, which served as the trustee of the former shareholders of Xinji
.

UMB argued that Bristol-Myers Squibb failed to "work hard" to obtain approval for the drug, thereby violating the CVR agreement

UMB claims that Bristol-Myers Squibb made a “very atypical decision to exclude critical and mandatory information in its initial application”, and that the company spent another 2 months “delaying” its submission to the initial FDA The "significant revision" of the application has "automatically extended" the target date of the treatment's approval application to November 17, 2020
.

In addition, UMB insisted that Bristol-Myers Squibb’s failure to “take the necessary measures to prepare for the FDA inspection” of the two production facilities and factories also prevented the drug from being approved as scheduled

The FDA conducted an inspection of a Lonza virus vector factory in Houston, USA from December 3 to 10 last year, which plans to help produce Breyanzi
.

But the lawsuit alleges that the factory ultimately failed the FDA inspection because it violated FDA regulations in a "large and serious" manner

       It is worth noting that the return of the CVR agreement also depends on the approval of two other former new base drugs on a specific date: Zeposia for multiple sclerosis and Abecma for multiple myeloma
.

However, both have achieved their respective milestones and were approved by the FDA in March 2020 and March this year.

       In this regard, Bristol-Myers Squibb has a different interpretation
.

At the beginning of this year, a Bristol-Myers Squibb spokesperson stated in an interview with FiercePharma that if it had not been for “the delay in inspections caused by COVID,” the company could have reached Breyanzi’s milestone approval

       In the lawsuit, UMB argued that “other cell therapies based on similar technologies have been approved by the FDA, and there are no problems that have plagued Bristol-Myers Squibb, and the drug approval time should be greatly shortened
.

” In fact, the same type of lymph Tumor drugs, including Novartis Kymriah and Gilead Yescarta, received FDA approval within 7 weeks of 2017, more than 2 years before Bristol-Myers Squibb was approved

       Reference source: It had to happen: Ex-Celgene shareholders sue Bristol Myers Squibb for $6.
4B in lost CVR cash, claiming'blatant misconduct'