key Takeaways:
- Novo Nordisk announced that the shortage of lower doses of its GLP-1 therapy, Ozempic (semaglutide), is expected to continue into the fourth quarter of 2024 due to high demand and limited production capacity.
- The company has faced ongoing manufacturing issues, exacerbated by a third-party provider halting deliveries in 2021 due to Good Manufacturing Practices violations.
- Novo has made substantial investments to increase its production capacity, including $6 billion for its Denmark operations, $16.5 billion for the acquisition of Catalent, and $4.1 billion for a new production facility in North Carolina.
Novo Nordisk’s ongoing struggle with supply issues for its popular GLP-1 therapy, Ozempic (semaglutide), is expected to continue into the fourth quarter of 2024. The Danish pharmaceutical giant announced that the shortage of lower doses of Ozempic will persist, with sporadic availability of higher doses also anticipated.
The supply constraints are largely driven by the soaring demand for Ozempic, coupled with limitations in production capacity. Since the approval of its sister brand, Wegovy (semaglutide), in June 2021 for chronic weight management, Novo Nordisk has been unable to keep pace with the overwhelming market demand, further exacerbated by manufacturing challenges.
Production Woes and Strategic Investments
The situation was worsened in December 2021 when a third-party fill-finish provider halted deliveries due to issues related to Good Manufacturing Practices. Despite these challenges, Novo has made significant investments to bolster its manufacturing capabilities. The company has earmarked substantial funds towards expanding its operations, including a $6 billion investment in Denmark in November 2023 and a $16.5 billion acquisition of CDMO giant Catalent in February 2024. Additionally, Novo is constructing a 1.4-million-square-foot production facility in Clayton, North Carolina, with a $4.1 billion investment announced in June 2024.
These efforts have enabled Novo to clear most of the shortages of both Ozempic and Wegovy, although the lowest dose of Wegovy is still expected to be in limited supply into Q4. The FDA’s drug shortages database reflects this progress but does not specify when the shortage will be fully resolved.
Expanding GLP-1 Therapy Indications and Increasing Pressure
Amid these supply challenges, Novo continues to push the boundaries of semaglutide’s therapeutic applications. Wegovy recently gained FDA approval in March 2024 for reducing the risk of cardiovascular death, heart attack, and stroke in overweight or obese patients with cardiovascular disease. This expansion into new indications potentially increases the patient pool, thereby intensifying the demand and pressure on Novo’s supply chain.
In a strategic move to support this effort, Novo published a pooled analysis on Monday using data from several Phase III studies, including SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM. The analysis, which involved over 3,000 patients, demonstrated that semaglutide significantly reduces the risk of combined cardiovascular death or worsening heart failure by 31% compared to placebo. These findings, published in The Lancet, could bolster Novo’s case for the use of semaglutide in heart failure treatment, especially after the company had to withdraw its heart failure filing for Wegovy last month. Novo has stated its intention to resubmit this filing early next year.
As Novo Nordisk continues to navigate its supply challenges, the company remains committed to expanding the indications for its GLP-1 therapies. While significant investments are being made to enhance production capacity, the persistent demand for Ozempic and Wegovy underscores the ongoing challenges the company faces. The forthcoming months will be critical as Novo seeks to balance its ambitious expansion goals with the realities of its production limitations.
Resource: Biospace, September 03, 2024
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