Wegovy: Thermo Fisher allegedly second CDMO for Novo Nordisk

Novo Nordisk has added Thermo Fisher as a second external drug product maker for weight-loss drug Wegovy, according to reports.

Earlier this year, Danish drugmaker Novo Nordisk said it had bolstered supply of semaglutide – approved as a ‘popular’ weight- loss drug under the brand Wegovy – through the addition of an undisclosed second contract development and manufacturing organization (CDMO).

But news outlet Reuters disclosed the third-party yesterday. Citing sources close to the matter, Reuters said Thermo Fisher is tasked with filling Wegovy injection pens at its Greenville, North Carolina facility, added through the acquisition of Patheon in 2017.

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Speaking on the firm’s Q2 2023 financial call, Novo Nordisk CFO Karsten Knudsen said the firm began 2023 with one contract manufacturing filling line for Wegovy, with a second added during the first half of the year.

He told stakeholders a third CDMO filling line is on track going into 2024, but again did not reveal the supplier. “And then on top of that, we will be adding additional filling line capacity. So a significant step-up in Wegovy capacity over time.”

These ramp-ups are in addition to in-house capabilities both on the peptide active pharmaceutical ingredient (API) as well as fill-finish capacity. The firm ploughed DKK 15.9 billion ($2.3 billion) into its Hillerød, Denmark site earlier this year, though details as to whether this would support future demand for Wegovy was not divulged.

Catalent’s beleaguered Brussels plant

The addition of a second (and potentially third) CDMO follows GMP issues at Novo Nordisk’s first CDMO, Catalent.

Catalent’s site in Brussels, Belgium received a Form 483 with seven observations following an inspection by the US Food and Drug Administration (FDA) in 2021, allegedly causing disruption in the supply of Wegovy.

The Brussels plant received a second Form 483 following a reinspection in August and September 2022, revealing nine observations.

In April this year, Catalent admitted “productivity challenges and higher-than-expected costs” at the Brussels plant, along with its Bloomington, Indiana site. “The Company was unable to achieve anticipated productivity levels and associated revenue due in part to the continued need to implement enhancements to its operational and engineering controls following regulatory inspections that occurred earlier in the fiscal year.”

Last week we reported a shareholder-led lawsuit has been filed claiming, among financial misreporting, the CDMO cut corners in its biomanufacturing processes during the pandemic, including at the Brussels plant.