The deliberate acquisition of Catalent by Novo Holdings has been postponed once more. Simply weeks after Novo Holdings determined to resubmit its utility to the Federal Commerce Fee, the company is searching for extra details about the deal.

The transaction was initially anticipated to shut by the tip of this yr, however this timeline is probably not as stable given the repeated delays within the FTC's overview course of.

The acquisition was introduced in early February when Novo Holdings – the funding arm of the muse that owns a majority stake in Danish pharmaceutical large Novo Nordisk – introduced its plans to amass New Jersey-based contract improvement manufacturing group Catalent for $16.5 billion.

Catalent is likely one of the largest CDMOs within the life sciences subject. It reported $4.2 billion in web revenues for the fiscal yr ended June 30, 2023.

Ought to the deal shut, Novo Nordisk pays Novo Holdings $11 billion to amass three of Catalent's manufacturing websites specializing in filling vials for sterile injectable medicine. The websites are positioned in Belgium, Italy and Indiana.

These websites have already got ongoing relationships with Novo Nordisk as a part of the drugmaker's international manufacturing infrastructure for its GLP-1 agonists. Demand for Ozempic and Wegovy – two GLP-1 medicine made by Novo Nordisk – continues to skyrocket, and buying these websites would considerably improve the drugmaker's manufacturing capability.

“We’re more than happy with the settlement to amass Catalent's three manufacturing websites, which can enable us to serve considerably extra individuals with diabetes and weight problems sooner or later,” mentioned Lars Fruergaard Jørgensen, CEO of Novo Nordisk, in a February press launch.

The primary delay within the FTC's overview course of for this deal got here a month in the past when Novo Holdings withdrew and resubmitted its utility for approval of the deal after “casual discussions with FTC workers.” This was carried out to “present the FTC further time to overview the transactions,” based on the refiling. The refiling led to a 30-day extension of the FTC's antitrust overview.

And final week, the FTC requested further paperwork and knowledge from Catalent and Novo Holdings — a transfer that prompted one other 30-day extension of the company's overview.

Each Novo Holdings and Catelent are gathering extra info to supply to the FTC “as rapidly as doable,” based on a securities submitting from Catalent.

Eli Lilly is probably the most outstanding voice questioning the proposed acquisition, which is not any shock contemplating the drugmaker is Novo Nordisk's essential competitor in GLP-1. Mounjaro and Zepbound from Eli Lilly are direct rivals of Ozempic and Wegovy from Novo Nordisk.

Like Novo Nordisk, Eli Lilly can be struggling to maintain up with skyrocketing demand for GLP-1 medicine. In November, the drugmaker introduced plans for a brand new $2.5 billion manufacturing website in Germany to fulfill rising demand for its injectable diabetes and weight problems medicine.

Simply days after Novo Nordisk introduced its plans to amass Catalent, Eli Lilly CEO David Ricks informed the newspaper Monetary occasions that he discovered the deal “uncommon” given the rising scrutiny of antitrust authorities on mergers within the biopharmaceutical sector.

Simply days after the deal was introduced, Eli Lilly CFO Anat Ashkenazi expressed considerations about how the acquisition would have an effect on his firm's excellent contracts with Catalent.

“Catalent is an integral half or producer of each industrial and pipeline merchandise for the trade, particularly within the areas of diabetes and weight problems, and we have now merchandise in these areas as effectively,” he mentioned throughout an earnings name. “So our focus in the present day is on guaranteeing that the continuity of the availability of medicines to sufferers is uninterrupted, and we additionally intend to carry Catalent accountable for his or her contract with us.”

Novo Nordisk has mentioned it can honor all earlier buyer commitments from the three amenities it plans to amass. The drug producer didn’t reply MedCity information' request for extra feedback.

In an announcement despatched to MedCity InformationA spokesperson for Catalent mentioned they’re “assured within the many advantages of the transaction” and nonetheless anticipate the deal to shut earlier than the tip of the yr.

Picture: illustration, Getty Photos