Novo Nordisk is struggling to meet strong demand for Wegovy, and the company has reportedly tapped another contract manufacturer to churn out the popular weight-loss drug.
Thermo Fisher is helping Novo fill the injection pens for Wegovy, Reuters reports, citing a source familiar with the matter. Through its CDMO subsidiary Patheon, Thermo is offering the manufacturing service at a factory in Greenville, North Carolina, according to the news service.
A Novo Nordisk spokesperson confirmed that a second contract manufacturer came online in April to help increase Wegovy supply.
That month, Novo hiked its 2023 revenue growth outlook to a range of 24% to 30%, up from a February range of 13% to 19%. The second Wegovy production contractor enabled that significant increase, Novo’s CEO Lars Fruergaard Jørgensen said on the company’s first-quarter earnings call in May.
Then, early this month, the company further dialed up its full-year sales projection by seven percentage points on both ends thanks to continued strong demand for its diabetes and obesity meds.
Novo appears to have signed Thermo Fisher after Catalent, its first contractor, kept dropping the ball. Only months into Wegovy’s launch, Catalent’s deliveries of Wegovy were temporarily halted in late 2021 after the FDA found various problems at the CDMO’s syringe-filling facility in Brussels. The plant shut down again in August 2022 when another FDA inspection found lapses. The FDA later downgraded the citation and allowed the plant to remain operational.
Catalent’s woes apparently stretched beyond Wegovy and the Belgium site. Last year, an FDA Form 483 slapped on Catalent’s Bloomington, Indiana, facility delayed the supply of Moderna’s COVID-19 booster. Just a few weeks ago, shortfalls at the Indiana plant tripped up Regeneron’s high-dose Eylea application. Those issues were all later resolved.
As for Thermo Fisher, its Greenville facility serves as a multipurpose drug manufacturing site covering solid dosages, sterile drugs and secondary packaging. It’s Thermo’s first facility to feature a fully functional continuous manufacturing line, according to the company’s website.
Despite Thermo’s help, Novo is still having trouble making enough Wegovy and its sister drug Ozempic. And the shortage has lately spread to Novo’s older-generation obesity med Saxenda.
To cope with the situation, Novo in May paused some promotional efforts around Wegovy, including TV ads and marketing communications with healthcare professionals. To control new patient starts, the Danish pharma also started limiting the supply of lower doses of Wegovy.
In a statement, the Novo spokesperson said that although the company is shipping all dose strengths, it’s still limiting quantities of three low-dose strengths to “support continuity of care for existing patients.”
Demand continues to outpace Novo’s increasing supply, the spokesperson said, so patients will have difficulty filling Wegovy. But Novo has “solid plans in place for continuously increasing Wegovy capacity in the coming years,” the spokesperson added.
At the end of 2021, Novo announced a $2.58 billion plan to expand its Kalundborg, Denmark, campus and build three new manufacturing facilities. Expected to be complete in 2027, the investment will increase Novo’s capacity to produce active pharmaceutical ingredients.
Thermo Fisher declined to comment for this story.