Compounded versions could make up as much as 40% of the semaglutide market, said Novo Nordisk CEO Lars Fruergaard Jorgensen on Thursday, but the company hopes to win patients over.
Novo Nordisk CEO Lars Fruergaard Jorgensen says U.S. drug compounders are harming the Danish pharma’s lucrative weight loss business and violating its intellectual property. Moreover, patients may not even know they are not getting the real thing.
“There’s only one semaglutide. That’s what is in our products and patients should really check the product before they inject it,” Jorgensen said during an investor presentation Thursday.
These compounded versions of the drug, which is marketed by Novo as Wegovy for weight loss and Ozempic for diabetes, could make up as much as 40% of the market, Jorgensen said. He added that Novo has tested some of the compounded semaglutide products and found impurities and banned substances.
“The thought that in the U.S., you can have active pharmaceutical ingredient coming from overseas sources and then have local pharmacies, compounders make products available for patients that are not FDA approved is quite scary,” Jorgensen said.
He noted that these products are, in the company’s view, illegal. Semaglutide was added to the FDA’s shortage list in 2022. This allowed compounding pharmacies to step in and manufacture product while Novo expanded manufacturing and boosted supply. But the drug was removed from the list in February and compounders were ordered to phase out the products. Jorgensen said the pharmacies have until late May to stop bulk compounding.
“I sincerely hope many of those patients will then come back to Novo Nordisk,” the CEO said. To ensure they do, Novo is stepping up commercial efforts to educate patients and doctors.
Jorgensen admitted that compounders are “damaging our business.” The company is working closely with the FDA on the issue, and the CEO noted that even the FBI has been shutting down compounders, while efforts in border control are underway.
The company is also taking legal action against the compounders, who have sued the FDA over the removal of semaglutide and Eli Lilly’s rival med tirzepatide from the shortage list.
“We hope that we will see the turn of compounding because of safety for patients,” Jorgensen said. “But of course, also that we have the patent-protected product that we have invested in developing it, and we would like to have the business for as long as it is patent-protected and then others can move in afterwards.”
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