Eli Lilly alleged that some its products were being processed at sites affected by the deal as Catalent also makes drugs for it
Novo Nordisk is set to acquire three fill-finish sites from Catalent. (Credit: Jonathan Schilling from Wikimedia Commons)
The European Union’s (EU) European Medicines Agency (EMA) will evaluate the impact on the availability of drugs produced at Catalent’s fill-finish sites that will be sold to Novo Nordisk.
The EU drugs regulator will investigate the impact under its authority to prevent drug shortages.
In a statement to Reuters, the EMA said that its Medicine Shortages Single Point of Contact (SPOC) Working Party will communicate with member states to obtain information about the goods produced at the locations.
Additionally, the SPOC party will assess the possible impact on the availability of these drugs. The names of the medications in question were not disclosed.
Earlier this week, Novo Nordisk’s parent company Novo Holdings entered into a deal to buy Catalent for $16.5bn to increase the production of its obesity drug, Wegovy. Catalent is the key manufacturing subcontractor of this drug.
Under the deal, three of Catalent’s fill-finish sites in Anagni, Italy, Brussels, Belgium, and Bloomington, US, are being sold to Novo Nordisk for $11bn.
Eli Lilly, Novo Nordisk’s main competitor in the obesity and diabetes drug sector, alleged that some of its products are being processed at sites affected by the latest transaction. This is because Catalent also makes drugs for the US-based Eli Lilly.
The American pharma major’s finance chief Anaz Ashkenazi claimed that Catalent was an integral producer of both commercial and pipeline products for the diabetes and obesity industry.
Additionally, Eli Lilly’s CEO David Ricks told the Financial Times that the transfer of the three sites to Novo Nordisk presents potential antitrust issues.
In a separate development, the US Food and Drug Administration (FDA) found quality control lapses at Catalent’s Bloomington site.
The US drug regulator has discovered a pest in the manufacturing line during an inspection.
The FDA made five separate observations, including that Catalent neglected to examine inexplicable variations in specific product batches.
Additionally, the health regulator said that some written procedures designed to prevent microbial contamination of sterile products were also ineffective.
Catalent said that it will work on all regulatory inspections and any resulting observations. The manufacturing subcontractor has also the option to voluntarily fix the issues.