Full Press Release Details
Pictured: Novo Nordisk’s office in California/iStock,hapabapa
Danish pharma companyNovo Nordiskhas brought inThermo Fisher Scientificas a second manufacturer as demand for its weight-loss drug Wegovy (semaglutide) soars and amid Catalent’s production problems at a factory in Brussels, Belgium, according toreportingWednesday byReuters.
Thermo Fisher is reportedly filling Wegovy injection pens at its factory in Greenville, NC through its CDMO subsidiary Patheon.Reuters’ source declined to be named as the information was confidential, according to the news agency, which initiallyreportedback in May that Novo had brought on a second, then-unnamed manufacturer.
The news comes after reports of difficulties with Catalent, the first manufacturer contracted by Novo to produce Wegovy. Deliveries werehaltedin late 2021 only months after the drug’s launch, when the FDA found issues at the Brussels syringe-filling facility. The facility wasshut downagain in 2022 after another inspection by the regulator found lapses. Novo ended upcutting backpromotional efforts for the drug amid the production difficulties.
Nor was this the end of Catalent’s woes. An FDA Form 483 at one of itsproduction plantsdelayed production of its Moderna COVID-19 booster, and recent shortfalls in sanitation, maintenance, and equipment issues cited by the FDA saw the facilityshut downagain.
The company’s long-awaitedfinancial reportfor the third-quarter of 2023 saw revenues fall 19% below last year’s earnings for the same quarter, though this beat Wall Street projections. Shares actually rose 10% after the news broke, though this represents only a partial recovery; sharesfellover 40% from April after news of its operational issues broke.
Catalent CEO Allesandro Maselli said in the report that the “fundamentals of our business remain strong,” despite operational challenges. “We continue to make progress in addressing our previously announced operational challenges, while also completing our strategic investments in high-demand, high-growth areas and executing a company-wide cost-reduction plan,” he said. Part of that reduction plan includedlaying offhundreds of workers last year.