Bristol-Myers Squibb said Celgene would sell the drug, Otezla (apremilast), to Amgen. The pharmaceutical company had said it would seek a divestment of the drug to satisfy competition concerns from the FTC.
The agency said Friday that it had approved Celgene's Inrebic (fedratinib), the first new drug approved for the disease - a type of rare blood cancer - since the approval of Incyte's Jakafi.
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Celgene plans to file for approval of bb2121 (idecabtagene vicleucel) in myeloma in the first half of 2020, and lisocabtagene maraleucel in lymphoma in the fourth quarter of this year.
The drugmaker said Monday it would sell off the drug Otezla to address concerns about competition that the Federal Trade Commission had expressed in connection to the pending $74 billion deal. According to an analyst, BMS saw Otezla as competitive against its investigational TYK2 inhibitor.
BMS's acquisition of Celgene had attracted opposition from two institutional investors. However, one of them withdrew its effort to derail the deal despite continuing to voice opposition.
Approval of luspatercept in myelodysplastic syndrome and beta-thalassemia is expected in April 2020, or as early as December of this year if it receives FDA priority review, an analyst wrote.
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The news closely followed that of the FDA approving the first immunotherapy drug for cancer, Roche's Tecentriq, in combination with Abraxane.
Two major shareholders in BMS - Wellington Management and Starboard Value - said they would not support the deal and saw it as poorly thought out.
In a call to following news of the deal, executives pointed to near-term launch opportunities and pipelines, but some analysts expressed concern about the loss of patent protection for Revlimid and Opdivo.
The acquisition brings together two of the largest drugmakers in the country, both of which are major players in biopharma, particularly oncology.
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