Novo Holdings set to close $16.5B Catalent buy in 'coming days' after deal clears antitrust hurdles

After clearing all regulatory hurdles associated with its proposed buyout of CDMO Catalent, Novo Holdings is nearly ready to unwrap its $16.5 billion present just in time for the holidays.

The deal, which should make for the largest biopharma M&A transaction of the year, is expected to close “in the coming days" now that the two companies have "fulfilled all regulatory closing conditions for their pending transaction," the companies said in a Saturday press release. The United States Federal Trade Commission declined to challenge the buyout, according to Bloomberg.

“With the support of Novo Holdings and access to additional resources, Catalent will be well-positioned to drive innovation and enhance offerings for the benefit of customers and the patients they serve, ultimately accelerating our strategy to create value for stakeholders,” Catalent’s CEO, Alessandro Maselli, said in the release.

The buyout has been under scrutiny from lawmakers, trade organizations and others since the companies announced the agreement in early February. Given Catalent’s firepower in GLP-1 drug manufacturing, one aspect of the deal that raised eyebrows is Novo Nordisk’s plan to purchase three of Catalent’s fill-finish sites from Novo Holdings for $11 billion after the transaction closes.

In October, Sen. Elizabeth Warren, D-Massachusetts, penned a letter to outgoing FTC chair Lina Khan, expressing concerns that the deal could “increase Novo Nordisk’s dominance over vital GLP-1 inhibitor drugs, reducing competition and increasing prices for patients.”

The sentiment was shared by a dozen consumer groups and trade unions, which wrote to the FTC with similar concerns the following week.

With the booming popularity of GLP-1 drugs for diabetes and obesity, manufacturing capacity has been a constant area of focus for Novo Nordisk and Eli Lilly. Soon after the deal was announced, Lilly's former CFO Anat Ashkenazi said the company was left with “questions about the transaction” and that Lilly planned to hold Catalent accountable to a production contract.

Novo Nordisk has said it plans to “honor all existing contracts” at the Catalent sites should the deal go through, a spokesperson previously told Fierce Pharma.

The deal secured the green light from the European Commission (EC) earlier this month after an investigation determined that the proposed merger would “not raise competition concerns,” leaving the FTC review as the final remaining hurdle.