Novo Holdings, the parent organisation of Danish drugmaker Novo Nordisk, has secured European Commission (EC) unconditional antitrust approval for its proposed $16.5bn acquisition of Catalent.
In February this year, Novo Holdings agreed to acquire Catalent, and Novo Nordisk to acquire three fill-finish sites from Novo Holdings.
In May, Catalent stockholders voted to approve the pending transaction, which has been approved by the regulatory authorities in several jurisdictions.
EC said the transaction would not raise competition concerns in the European Economic Area (EEA), including the 27 EU countries, Iceland, Liechtenstein, and Norway.
The transaction is expected to be completed by the end of this year, subject to certain customary closing conditions, including receipt of all requisite regulatory approvals.
Catalent president and CEO Alessandro Maselli said: “We are pleased to have received European Commission approval, which is a significant milestone toward completing our pending transaction with Novo Holdings.
“I am deeply grateful for the ongoing commitment and efforts of the Catalent team. There is tremendous positive momentum underway at Catalent, and I believe that our future is even brighter as a private company with the support of Novo Holdings.”
Novo Holdings is the majority shareholder of Novo Nordisk, which develops treatments for chronic diseases such as diabetes and obesity, in the form of pre-filled syringes.
Its other subsidiary Orexo supplies Zubsolv, which is indicated for the treatment of opioid dependence, in orally disintegrating tablets (ODTs) format.
Catalent is a contract development and manufacturing organisation (CDMO) engaged in developing and manufacturing medicines on behalf of pharmaceutical companies.
The CDMO supplies pre-filled syringes and ODTs to the pharmaceutical industry, including Novo Holding’s subsidiaries.
The EU watchdog investigated the impact of the proposed transaction on the markets for the supply of pre-filled syringes, and ODTs.
EC found that pre-filled syringe customers can have access to several reliable CDMO alternatives to Catalent, including Thermo Fisher, Vetter, and Pfizer, among others.
Hence, the regulator concluded that the proposed transaction would not raise competition concerns in any of the markets examined in the EEA.
Novo Holdings senior partner Jonathan Levy said: “With the European Commission’s approval, we are one step closer to delivering the benefits of this transaction.
“We look forward to supporting Catalent in its next chapter as it continues to create value for stakeholders, ultimately delivering better outcomes for the company’s customers and the patients they serve.”
