Manufacturing Challenges for Novo Nordisk’s Ozempic Impact Diabetes and Obesity Treatments in Europe

Novo Nordisk (NYSE: NVO), a leading Danish pharmaceutical company, has released a joint statement with the European Medicines Agency (EMA) addressing the ongoing supply challenges for its GLP-1 receptor agonist, Ozempic (semaglutide). The statement cites increased demand and manufacturing site capacity constraints as the primary factors contributing to the shortages, particularly affecting lower dosage strengths of the medication. Ozempic is indicated for the treatment of type 2 diabetes, with Wegovy being the corresponding brand for the anti-obesity formulation of semaglutide.

The company has advised healthcare providers to limit the initiation of new patients on Ozempic until the supply situation is expected to improve in September 2024. In an effort to boost Ozempic production, Novo Nordisk temporarily reduced supplies of Victoza in Q4 2023, leading to intermittent shortages in some EU/EEA countries despite improvements since Q1 2024.

In the competitive landscape of GLP-1 drug manufacturing, Novo Nordisk and Eli Lilly & Co. are at the forefront, with the latter’s tirzepatide marketed as Mounjaro for diabetes and Zepbound for weight loss. Both companies have been ramping up production to meet the surging demand, especially in the obesity treatment sector. Novo Nordisk’s parent company, Novo Holdings, announced a $16.5 billion acquisition of Contract Manufacturing Organization (CMO) Catalent in January 2024, with an expected closure towards the end of the year, aiming to take direct control of three of Catalent’s factories for an additional $11 billion. Concurrently, in May 2024, Lilly declared a $5.3 billion investment to establish a substantial new facility in Indiana for tirzepatide production. The FDA confirmed in August that Eli Lilly’s GLP-1 drugs, Zepbound and Mounjaro, have been removed from the in-shortage list following resolution of supply issues.

Financially, Novo Nordisk’s sales of GLP-1 drugs for diabetes, including Ozempic, Victoza, and Rybelsus, reached DKK 61,086 million (USD 9.04 billion) in H1 2024, with Ozempic accounting for DKK 56,685 million (USD 8.4 billion) of those sales. Wegovy’s sales for obesity treatment alone added DKK 21,036 million (USD 3.12 billion) to the tally. In comparison, Lillly reported total GLP-1 sales of USD 6.65 billion during the same period. – Flcube.com

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