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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.”
原文链接：www.biospace.com
背景介绍：
在美国，司美格鲁肽（semaglutide）于 2022 年被列入美国食品药品监督管理局（FDA）的短缺清单，这使得配制药房能够介入并生产相关产品。正是这些药房或制剂商的复方制剂损害了这家丹麦制药公司-诺和诺德（Novo Nordisk）在减肥领域颇具盈利性的业务。
原文注释：
semaglutide 司美格鲁肽，丹麦诺和诺德公司研发的药物，属于一类被称为胰高血糖素样肽 - 1 受体激动剂（GLP-1 RAs）的药物，它模拟进食后由肠道释放的 GLP-1 激素。GLP-1 的一项作用是促使身体分泌更多的胰岛素，从而降低血糖（葡萄糖）。因此，司美格鲁肽可用于治疗 2 型糖尿病（商品名为Ozempic）。较高剂量的司美格鲁肽还会与大脑中抑制食欲的部分相互作用，它能够促使肥胖或超重人群减重，用作减肥药（商品名为Wegovy）。Ozempic和Wegovy是剂量不同的司美格鲁肽药物。
tirzepatide 替尔泊肽（商品名为Zepbound），是美国礼来公司（Eli Lilly and Company）研发成功上市的一种新型的GIP（胃抑制多肽）和GLP-1双受体激动剂，靶向治疗糖尿病、非酒精性脂肪性肝炎（NASH）和慢性体重管理。
词汇：lucrative adj.获利多的；impurity n.杂质；pharmaceutical adj.制药的；phase out 逐步淘汰；step up 提高；patent n.专利
本期制作：Gilly
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