Bristol-Myers Squibb announced Friday that the US Federal Trade Commission (FTC) has cleared its pending $74-billion acquisition of Celgene, and that the merger is now expected to become final on November 20. The decision follows Celgene's recent agreement to sell Otezla (apremilast) to Amgen for $13.4 billion in a bid to ease competition concerns by the agency.
According to the FTC, the Otezla divestiture represents the largest that the antitrust regulator or the US Department of Justice has ever required in a merger enforcement matter. FTC chairman Joseph Simons said the requirement was meant "to preserve Bristol-Myers Squibb's incentive to continue developing its own oral product for treating moderate-to-severe psoriasis."
The company's TYK2 inhibitor BMS-986165 is currently in Phase III testing for various immuno-inflammatory disorders (for related analysis, see ViewPoints: Amgen agrees to book Bristol-Myers Squibb's big bet on TYK2). The FTC claims that the therapy "will likely be the next entrant into the market and would compete directly with Otezla."
Under the terms of the proposed consent order, Bristol-Myers Squibb and Celgene must offload Otezla to Amgen no later than 10 days after their merger is finalised. However, if the FTC determines that Amgen, which markets Enbrel (etanercept) and the biosimilar Amjevita (adalimumab-atto) for various autoimmune diseases, is "not an acceptable acquirer, or that the manner of the divestitures is not acceptable," Otezla will have to be divested to an FTC-approved acquirer "within six months of the date the order."
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