The US Federal Trade Commission (FTC) has accepted a proposed consent decree in connection with AbbVie's pending $63-billion acquisition of Allergan, the companies announced. The FTC's decision means that all required antitrust clearances needed for the merger have now been obtained.
Following a review of the planned takeover, the FTC determined that the combination would "eliminate future direct competition" between AbbVie and Allergan regarding development and sales of IL-23 inhibitor drugs in the US to treat moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. The antitrust watchdog concluded the deal would also likely result in "substantial competitive harm" to the market for exocrine pancreatic insufficiency treatments.
Under the proposed consent order, which was first detailed in March, Allergan agreed to divest brazikumab, an investigational IL-23 inhibitor under development for moderate-to-severe Crohn's disease and ulcerative colitis, to AstraZeneca, which was the initial developer of the compound, also known as MEDI2070, prior to out-licensing it to Allergan in 2016. According to the FTC, the proposed order returns the drug to AstraZeneca under terms that "incentivise [the UK drugmaker] to bring the product to market." The regulator noted that Johnson & Johnson's Stelara (ustekinumab) is the only FDA-approved IL-23 inhibitor for both conditions, while AbbVie, Allergan and Eli Lilly are currently the only other companies that have IL-23 inhibitors in late-stage development.
The consent decree will also see Nestlé acquire the pancreatic enzyme products Zenpep (pancrelipase) and Viokace (pancrelipase). The FTC said that following a vetting process of proposed buyers, Nestlé was found to have "the expertise, US sales infrastructure and resources to maintain the competition that otherwise would have been lost due to the proposed acquisition." Allergan had entered agreements to offload the products to AstraZeneca and Nestlé back in January.
The planned merger between AbbVie and Allergan has already won antitrust clearance in the EU on condition that brazikumab be sold, as well as in China and Brazil, although it still needs approval from the Irish High Court, where a hearing is scheduled for May 6. The companies have said they expect the deal to be finalised this month.
Meanwhile, the drugmakers said they have amended their agreement to provide that only one Allergan director will join the AbbVie board following close. Allergan's current CEO Brent Saunders has elected not to join the AbbVie board so he has "more flexibility to pursue other opportunities in the sector."
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