AbbVie/Allergan merger cleared in EU with brazikumab sell-off

AbbVie and Allergan’s $63 billion merger has been cleared by European regulators, who have approved the sell-off of pipeline gastrointestinal autoimmune diseases drug brazikumab to AstraZeneca.

The divestiture is a condition imposed by the European Commission, which is concerned that the merged company will have too much influence in this sector of the market should brazikumab get approved.

AbbVie already has the world’s biggest selling drug with Humira (adalimumab), which is used in a range of inflammatory diseases including rheumatoid arthritis and psoriasis.

Concerned that the merged company would have too much market share in diseases such as Crohn's and ulcerative colitis, the European Commission asked Allergan to sell off brazikumab to a “suitable purchaser”.

AstraZeneca has stepped in and agreed to recover rights to brazikumab, which was developed by its MedImmune biologics division in partnership with Amgen.

In 2016 the UK pharma had opted to sell off brazikumab, a monoclonal antibody which targets IL-23, in a deal worth more than $1.5 billion if all development goals were met.

The drug works by selectively blocking the IL-23 immune signal and preventing intestinal inflammation.

It is being tested against Humira in the phase 2b/3 INTREPID clinical trial programme in Crohn’s disease, and against Takeda’s Entyvio (vedolizumab) in ulcerative colitis.

AZ has now officially passed the commission’s “suitable purchaser” test clearing the way for merger approval in Europe. The closing transaction is also subject to Irish High Court approval.

The United States Federal Trade Commission (FTC) continues to review the pending transaction, which is not subject to a specific timeline.

However, the companies have entered into a timing agreement with FTC staff that would likely result in a decision by the FTC early in Q2.

The companies said they “continue to fully cooperate with the FTC during its review and intend to close the transaction at the earliest possible date.”