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Bristol-Myers is sued for $6.4 billion over delayed cancer drug

Bristol Myers interested in buying Aurinia Pharma - Bloomberg News
Bristol Myers interested in buying Aurinia Pharma - Bloomberg News   -   Copyright  Thomson Reuters 2021   -  
By Reuters

<div> <p>By Jonathan Stempel</p> <p><span class="caps">NEW</span> <span class="caps">YORK</span> – Bristol Myers Squibb Co was sued for $6.4 billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019.</p> <p>According to a complaint in Manhattan federal court, Bristol Myers failed to use contractually required “diligent efforts” to win U.S. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec. 31, 2020, deadline.</p> <p>By missing the deadline, Bristol Myers was excused from owing an additional $9 in cash to Celgene shareholders for each share they held, enabling it to acquire Celgene at an “enormous discount” and enjoy a “windfall,” the complaint said.</p> <p>Bristol Myers bought Celgene for $80.3 billion in cash and stock in November 2019. It won <span class="caps">FDA</span> approval for Breyanzi, whose chemical name is lisocabtagene maraleucel, on Feb. 5.</p> <p>The lawsuit was brought by <span class="caps">UMB</span> Bank NA, acting as a trustee for Celgene’s former shareholders.</p> <p>“We will not be commenting on pending litigation,” Bristol Myers said in a statement. </p> <p>The $9 per share “milestone” payment had been contingent on New York-based Bristol Myers winning <span class="caps">FDA</span> approval by specified deadlines for three drugs that Celgene had been developing.</p> <p><span class="caps">UMB</span> said Bristol Myers withheld or belatedly submitted critical information to the <span class="caps">FDA</span> for Breyanzi’s approval, and did not prepare its manufacturing plants for required inspections.</p> <p>“Other cellular therapies based on similar technology have received <span class="caps">FDA</span> approval without the issues and ineptitude that plagued Bristol Myers, and in substantially less time,” <span class="caps">UMB</span> said.</p> <p>A lawyer for the Kansas City, Missouri-based bank declined additional comment.</p> <p>Bristol Myers won <span class="caps">FDA</span> approval for the two other Celgene drugs, Zeposia for multiple sclerosis and Abecma to treat multiple myeloma, by the specified deadlines.</p> <p>The case is <span class="caps">UMB</span> Bank NA v Bristol-Myers Squibb Co et al, U.S. District Court, Southern District of New York, No. 21-04897.</p> <p/> </div>