Novo Holdings has secured unconditional approval from the European Union’s antitrust regulators for its proposed $16.5 billion acquisition of U.S.-based contract development and manufacturing organization Catalent.
The European Commission announced Friday that the merger posed no competition concerns within the European Economic Area (EEA), which includes EU member states as well as Iceland, Liechtenstein, and Norway.
“With the European Commission’s approval, we are one step closer to delivering the benefits of this transaction,” Jonathan Levy, senior partner at Novo Holdings, said in a statement.
In a separate but related transaction, Novo Nordisk has agreed pay Novo Holdings $11 billion to take over three Catalent fill-finish sites in Italy, Belgium and Indiana to help expand production of its blockbuster drugs Ozempic and Wegovy.
Catalent and Novo Holdings in a joint press release said the proposed acquistion is “expected to close towards the end of calendar year 2024, subject to the satisfaction of other customary closing conditions, including receipt of all requisite regulatory clearances.”
The EU clearance comes amid ongoing scrutiny of the deal in the U.S. Both Catalent and Novo Holdings received a “second request” for information from the Federal Trade Commission (FTC) earlier this year, extending the regulatory review process by an additional 30 days once the companies submitted the requested materials.
This is the second time Novo has had to refile its application with the FTC. According to Catalent, Novo initially submitted its request in March but withdrew it and resubmitted in April following discussions with FTC staff.
While Friday’s EU approval advances the deal, continued FTC scrutiny highlights a growing trend of regulatory delays in the pharmaceutical sector. Amgen faced a similar “second request” for its $27.8 billion acquisition of Horizon Therapeutics, which was finalized only after a settlement with the FTC months after the initial target date.