US Federal Trade Commission Seeks Additional Information on Novo Nordisk Parent-Catalent Deal

The United States Federal Trade Commission (FTC) is seeking more information on Novo Nordisk parent’s $16.5 billion proposed acquisition of Catalent, a US-based contract development manufacturing organization (CDMO). Catalent stated on May 3, 2024 that both companies were gathering information in order to respond to the FTC’s request (1), which was received on May 2. This request was submitted weeks after an application to the FTC was refiled to approve the deal.

Novo Nordisk announced its decision to acquire Catalent in early February 2024 (2). Under a planned merger of Novo Holdings, the parent company of Novo Nordisk, and Catalent, Novo Nordisk would receive three of Catalent’s fill/finish sites and related assets. Those three sites, located in Anagni, Italy; Bloomington, Indiana (US); and Brussels, Belgium, would be advantageous for Novo Nordisk, which has been steadily increasing production of Wegovy as demand for the drug explodes.

Novo Nordisk emphasized its goals of expanding Wegovy production in its own press release on the acquisition (3). The deal would enable the company to expand manufacturing capacity while allowing flexibility for its existing supply network. “We are very pleased with the agreement to acquire the three Catalent manufacturing sites which will enable us to serve significantly more people living with diabetes and obesity in the future,” said Lars Fruergaard Jørgensen, president and chief executive officer, Novo Nordisk (2). “The acquisition complements the significant investments we are already doing in active pharmaceutical ingredients facilities, and the sites will provide strategic flexibility to our existing supply network.”

Demand for Wegovy, Novo Nordisk’s obesity and cardiovascular disease treatment, has skyrocketed over the last year, alongside its sister diabetes therapy, Ozempic. Wegovy was approved in the US in early March of 2024 to reduce risk of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke in either overweight or obese adults with established cardiovascular disease (CVD) (4). Novo Nordisk also filed for a label expansion in the European Union.

Both Novo Nordisk and Catalent still expect to close the deal by the end of 2024, but doubts were raised when Novo Nordisk refiled the application in April. According to a Reuters press release, David Ricks, CEO of Eli Lily, a major competitor to Novo Nordisk and Wegovy, raised potential antitrust concerns, calling Novo Nordisk’s proposal to buy the plants “unusual” (4). Novo Nordisk did not disclose details about why the application was refiled.

References

1. US SEC. Form 8-K. Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, Catalent, Inc. May 3, 2024. https://www.sec.gov/Archives/edgar/data/1596783/000119312524129990/d797118ddefa14a.htm
2. Mirasol, F. Novo Holdings to Acquire Catalent in Deal Valued at $16.5 billion. PharmTech.com, Feb 5, 2024.
3. Novo Nordisk, Novo Nordisk to Acquire Three fill-finish Sites from Novo Holdings A/S in Connection with the Catalent, Inc. Transaction. Press release, Feb 5, 2024.
4. Novo Nordisk, Wegovy Approved in the US for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular Disease. Press release, Mar 8, 2024.
5. Satija, B. US FTC Seeks More Information on Novo Nordisk Parent-Catalent Deal. Reuters.com, May 3, 2024.