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The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year after Novo Holdings’ $16.5 billion acquisition.
Endpoints News coverage1 has reported that Catalent, a global contract development and manufacturing organization (CDMO), is downsizing. The CDMO cites an “unexpected shift in demand from a large customer,” and will be laying off 350 employees from its Baltimore gene therapy plant.
Although the client is currently unknown, Sarepta Therapeutics, a genetic medicine company, is based at that location.
“Our gene therapy business continues to see strong growth and we look forward to working on behalf of customers to deliver novel therapies for patients with genetic diseases/disorders,” a Catalent spokesperson told Endpoints News. “It is never easy to see talented colleagues leave Catalent and we remain committed to providing them transition support as they manage this change.”
Catalent’s ownership changed hands last year, after Novo Holdings, Novo Nordisk’s parent company, agreed to acquire the CDMO in a $16.5 billion deal.2 The deal officially closed in December 2024.3 Per the transaction, Novo Nordisk purchased three manufacturing sites that Novo Holdings acquired from Catalent. Novo Nordisk paid out a combined $11 billion to its parent company for the three plants.
Novo Nordisk president and CEO Lars Fruergaard Jorgensen commented at the time of the annoucement that, “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. 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.”
These sites house fill-finish processes and will contribute to the increased supply of Wegovy.
The news comes at a point when the industry—particularly pharma manufacturing—has been gaining momentum, especially due to the role of CDMOs and contract manufacturing organizations (CMOs).
“The pharmaceutical manufacturing market has been undergoing significant growth since 2015 and is divided between and CMOs,” noted Bruce Phelan, a senior partner with Blue Fin Group, in an interview with Pharm Exec.4 “There has been a significant shift of pharmaceutical manufacturers core competencies, especially in manufacturing expertise and increased sophistication of complex products, and an increased reliance on CDMOs and CMOs for capacity and expertise, inclusive of API manufacturing as well as finished goods manufacturing.
“As such, small and large pharmaceutical companies have increased their outsourcing to their drug manufacturing CDMO or CMOs partners because they need access to manufacturing capacity or technological manufacturing capabilities beyond what they have within their in-house manufacturing capabilities and capacities and to mitigate potential risk of under supply or low yield. The global need for manufacturing capacity and technical expertise has significantly accelerated over the past seven to eight years and furthermore during the pandemic … Purchasing and vertically integrating a CDMO or CMO into pharmaceutical manufacturers supply chain is worth considering dependent upon the need for increased/excess supply of the finished goods (product), specific manufacturing requirements, the need for excess or increased capacity based on commercial product forecasting, and to manage downside risks of the lack of outsourced manufacturing capacity or the trained personnel to operate sophisticated manufacturing processes.”
However, the potential for CDMO and CMO growth aside, the FDA had issued a second complete response letter (CRL) to Regeneron’s odronextamab, based on issues with one of the aforementioned third-party manufacturing sites that had been purchased by Novo.5
Regeneron’s Biologics License Application (BLA) is seeking the approval of odronextamab for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL) and for R/R diffuse large B-cell lymphoma (DLBCL) following two or more prior lines of systemic therapy.
References
1. Brown A. Catalent Lays Off 350 Workers Over Change on Demand From a ‘Large Customer.’ Endpoints News. August 20, 2025. Accessed August 20, 2025. https://endpoints.news/catalent-lays-off-350-workers-over-change-in-demand-from-a-large-customer/
2. Hollan M. Novo Nordisk’s Parent Company to Acquire Catalent To Boost Supply of Wegovy. Pharmaceutical Executive. February 5, 2024. Accessed August 20, 2025. https://www.catalent.com/catalent-news/novo-holdings-completes-acquisition-of-catalent/
3. Novo Holdings Completes Acquisition of Catalent. Catalent. December 18, 2024. Accessed August 20, 2025. https://www.catalent.com/catalent-news/novo-holdings-completes-acquisition-of-catalent/
4. Hollan M. What Novo Nordisk’s Purchase of Catalent Means for the Industry. Pharmaceutical Executive. February 14, 2024. Accessed August 20, 2025. https://www.pharmexec.com/view/novo-nordisk-purchase-catalent-means-industry
5. James D. Regeneron Faces FDA Setbacks with CRL for Odronextamab, Delays on Eylea HD BLA Amid Third-Party Manufacturing Issues. Pharmaceutical Executive. August 1, 2025. Accessed August 20, 2025. https://www.pharmexec.com/view/regeneron-fda-crl-odronextamab-eylea
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