AbbVie, Allergan clear EU merger hurdle with GI candidate sale

As AbbVie and Allergan wade through U.S. regulatory review of their pending $63 billion merger, the EU has given the pair hope their transaction will pass muster. After offering a conditional approval for the deal in January pending the sale of one GI asset, the EU is now ready to offer its full blessing. 

The European Commission has approved AbbVie and Allergan's sale of late-stage candidate brazikumab, clearing the way for a final approval of the pair's merger, AbbVie said in a release.

The merger itself is pending a final close, but AbbVie said in a release the sale approval would "clear the pathway" to wrap up the transaction. The merger is also pending approval by the Irish High Court, AbbVie said.

Even with the EU finishing up its review, the merger still faces Federal Trade Commission (FTC) review, which AbbVie said could wrap by April per the two regulatory bodies' "timing agreement."

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Allergan cleared the EU's review hurdle in late January after it agreed to offload GI candidate brazikumab to AstraZeneca and two pancreatic replacement enzymes, Zenpep and Viokace, to Nestlé. 

Despite easing European antitrust concerns, a squad of union and consumer groups argued in February that the brazikumab sale wouldn't go far enough to level the post-merger playing field. 

In an FTC letter, the groups argued that AstraZeneca is ill-positioned to bring brazikumab to market and does not have a strong enough pipeline to actively compete with AbbVie's strong position in immunology. Moreover, AbbVie's controversial use of "rebate walls" for its products, including for psoriasis med Skyrizi, would likely put any possible competitor—brazikumab included—in a tough position to compete against the more established med, the groups argued.

In brazikumab, which regulators fear would overlap Skyrizi, the sale represented a return to sender for AstraZeneca, which offloaded the drug to Allergan in 2016. 

Barring some new hurdle the FTC could put in place, however, AbbVie hasn't publicly forecast any meaningful hurdles to consummating the deal.

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