Catalent's Bloomington Plant Making Novo Nordisk's Obesity Drug Faces FDA Scrutiny Regarding Drug Manufacturing Concerns

Novo Nordisk A/S NVO has encountered manufacturing challenges and drug shortages for its diabetes and weight loss drugs due to unprecedented demand for Wegvoy and Ozempic.

To manage the shortage, Novo Nordisk agreed to acquire three fill-finish sites from Novo Holdings A/S in connection with a transaction where Monday, Novo Holdings agreed to acquire Catalent Inc CTLT.

Novo Nordisk will acquire the three manufacturing sites for an upfront payment of $11 billion. 

The three manufacturing sites specialize in the sterile filling of drugs and are located in Anagni (Italy), Brussels (Belgium), and Bloomington (Indiana, US). 

The three sites employ more than 3,000 people and have ongoing collaborations with Novo Nordisk.

The parent company of Novo Nordisk agreed to pay $63.50 Per Share in Cash in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.

Notably, the FDA uncovered quality control lapses during an inspection in November, exposing various concerns, including the presence of a “pest” on the manufacturing line, as detailed in the inspection report.

The FDA inspection from October 31 to November 15 highlighted five distinct observations, Reuters reported. 

Catalent faced criticism for failing to investigate unexplained discrepancies in certain product batches thoroughly. 

The FDA’s report, obtained through a Freedom of Information Act request, revealed approximately 194 deviations recorded between October 31, 2021, and October 31, 2023, with Catalent unable to identify the root cause of 171 incidents.

The FDA’s findings included inadequacies in written procedures designed to prevent microbial contamination of sterile products. Instances of sterile-safety breaches, operators’ bare face/skin and gowns touching, apparent residues, and the discovery of ink on the manufacturing line raised concerns about Catalent’s adherence to quality control standards.

FDA inspectors visited the Brussels-based plant in October 2021 and August 2022 to assess its manufacturing regulatory compliance. 

The investigation revealed that employees at the Catalent factory, which handles Wegovy’s pen-filling process, did not consistently carry out required quality checks.

Price Action: CTLT shares are trading lower by 0.56% at $58.16 on the last check Wednesday.

Photo By Natalia Varlei On Shutterstock