Bristol Myers Faces $6.4B Lawsuit Over Delayed Approval of Breyanzi Non-Hodgkin Lymphoma Drug: Reuters

  • Bristol Myers Squibb Co BMY was sued for $6.4 billion for allegedly delaying approval for Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, acquired in 2019 for $80.3 billion in cash and stock.
  • According to a complaint in Manhattan federal court, Bristol Myers failed to use contractually required "diligent efforts" to win FDA approval for the non-Hodgkin lymphoma drug by December 31, 2020, deadline.
  • The complaint said that BMY withheld or delayed the submission of information for approval and did not prepare its manufacturing plants for required inspections.
  • By missing the deadline, Bristol Myers was excused from owing an additional $9/share in cash to Celgene shareholders, enabling it to acquire Celgene at an "enormous discount" and enjoy a "windfall," the complaint said.
  • FDA approval for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large b-cell lymphoma came in February 2021.
  • The lawsuit was brought by UMB Bank NA, acting as a trustee for Celgene's former shareholders.
  • "We will not be commenting on pending litigation," Bristol Myers said in a statement.
  • The $9 per share "milestone" payment had been contingent on New York-based Bristol Myers winning FDA approval by specified deadlines for three drugs that Celgene had been developing.
  • Bristol Myers won FDA approval for the two other Celgene drugs, Zeposia for multiple sclerosis and Abecma to treat multiple myeloma, by the specified deadlines.
  • Price Action: BMY shares are up 0.35% at $64.92 during the market session on the last check Thursday.
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