AbbVie and Allergan Receive FTC Clearance for $63 Billion Merger, Finalizing Asset Divestitures

Compiled by Keke

On May 5, AbbVie and Allergan announced that the U.S. Federal Trade Commission (FTC) had accepted their merger agreement. AbbVie has now satisfied all antitrust approvals required for the acquisition of Allergan, including Allergan’s agreement to sell brazikumab, an investigational IL-23 inhibitor for the treatment of autoimmune diseases, to AstraZeneca; and to sell Zenpep, a medication for exocrine pancreatic insufficiency caused by cystic fibrosis and other conditions, to Nestlé. In the same transaction, Nestlé also acquired Allergan’s other pancreatic enzyme product, Viokace.

Brazikumab is a monoclonal antibody that binds to the IL-23 receptor and is being developed alongside companion biomarkers for the treatment of Crohn’s disease and ulcerative colitis. The drug selectively blocks IL-23 immune signaling, thereby preventing intestinal inflammation. Currently, the Phase IIb/III INTREPID program is underway to evaluate the efficacy of brazikumab compared with placebo or adalimumab in the treatment of Crohn’s disease. In addition, the ongoing Phase II EXPEDITION trial is assessing the efficacy of brazikumab compared with placebo or vedolizumab in ulcerative colitis.

Zenpep is a pancrelipase indicated for patients unable to digest food properly due to insufficient pancreatic enzyme production; it helps the body utilize fats, proteins, and sugars from food. The medication contains a mixture of digestive enzymes (lipase, protease, and amylase) derived from porcine pancreas. Clinical studies have demonstrated that, compared with placebo, Zenpep enables patients with exocrine pancreatic insufficiency associated with cystic fibrosis to absorb more fat from their diet.

Viokace is a combination of porcine-derived lipase, protease, and amylase. In adults, this medication is often used in conjunction with proton pump inhibitors to treat exocrine pancreatic insufficiency caused by chronic pancreatitis or pancreatectomy.

Furthermore, AbbVie and Allergan amended their transaction agreement, stipulating that only one Allergan director would join the AbbVie Board of Directors upon closing of the transaction. Brent Saunders, Allergan’s then-Chairman and Chief Executive Officer, relinquished his board seat and chose to resign to pursue other opportunities.

In fact, the merger of the two pharmaceutical companies has been pending for nearly a year. In early March this year, the European Commission approved the acquisition. Now, the U.S. FTC has finally approved this major deal.

Currently, the $63 billion deal faces only final hurdles, with the acquisition subject to customary closing conditions stipulated in the transaction agreement and by the approval of the High Court of Ireland. The hearing at the High Court of Ireland is scheduled for today (May 6).

On the 5th, AbbVie also announced an extension of the expiration date of its tender offer to May 12 to exchange for the series of notes issued by Allergan. These are all conditions for the completion of the acquisition. AbbVie does not expect further delays.

Reference Source: AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go