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How compounders plan to continue making GLP-1s
How compounders plan to continue making GLP-1s

Axios

time21-05-2025

  • Business
  • Axios

How compounders plan to continue making GLP-1s

Drug compounders and telemedicine companies may be ready to defy a Food and Drug Administration ban on copycat GLP-1 weight-loss drugs that takes effect on Thursday, arguing the law still allows customized versions tailored to patients' needs. Why it matters: It would be the latest chapter in a battle with brand-name GLP-1 giants Novo Nordisk and Eli Lilly as millions try to get their hands on versions of the blockbuster drugs. Driving the news: Noom, a digital health company that prescribes compound semaglutide, the active ingredient in some of Novo's GLP-1s, said it will continue to offer compounded versions of the drug beyond the May 22 enforcement deadline. "The compounding law is clear," said CEO Geoff Cook. "There must be an individual patient benefit to the personalization. And so Noom works with [compounding] pharmacies to provide personalized medication when it's clinically indicated." When prescribing a compounded GLP-1, Noom has been following a "low and slow" approach to titrating up dosages in patients in a way that is not available in commercial versions of GLP-1s. Noom said it also prescribes brand name versions of GLP-1 products in a partnership announced earlier this year with Lilly Direct, as well as prescribing non-GLP-1 alternatives. "I think we are looking to be on very firm ground on when it's clinically indicated," Cook said. Yes, but: Pharma companies will likely challenge that interpretation. "Compounders should have already transitioned patients to approved medicine, and anyone continuing to sell mass compounded tirzepatide, including by referring to it as 'personalized,' 'tailored' or something similar, is breaking the law and putting patients at risk," Eli Lilly said in a statement to Axios. Catch up quick: The FDA allowed compounders to make cheaper copies of the drugs while they were in shortage. When the agency declared Novo and Lilly's drugs were in sufficient supply earlier this year, compounders were put on notice that most versions of GLP-1s copies would not longer be allowed. The compounding labs filed a challenge to put tirzepatide, the active ingredient in Lilly's GLP-1s, back in shortage. Earlier this month, a judge ruled against them. The FDA also allows compounding for prescriptions specific to particular patients.

Wellness companies eager to avoid WeightWatchers' fate embrace weight-loss drugs
Wellness companies eager to avoid WeightWatchers' fate embrace weight-loss drugs

The Herald

time11-05-2025

  • Business
  • The Herald

Wellness companies eager to avoid WeightWatchers' fate embrace weight-loss drugs

WeightWatchers, when it filed for bankruptcy, said its weight management system stopped being attractive to customers given changing views about weight versus wellness, competition from telehealth companies fully embracing the weight-loss drugs, and even fitness influencers on TikTok. The company has an agreement with creditors to restructure its debt and quickly exit the court process. Adam McBride, CEO of telehealth company Eden, said WeightWatchers, which tried to pivot to telehealth and sell weight-loss drugs, had an old school system that relied on points and in-person gatherings that customers didn't like. 'I don't think that they were listening to their members,' McBride said. Eden and rival Noom both operate weight-focused telehealth platforms with integrated lifestyle coaching — something WeightWatchers struggled with. The newer companies have been selling unbranded versions of the in-demand weight-loss medications as part of their offerings. Clinical subscriptions that provide access to clinicians and prescription drugs make up over half of Noom's revenue, said CEO Geoff Cook. At rival Hims and Hers, compounded weight-loss drugs accounted for 20% of revenue last year, and even WeightWatchers relied partly on such revenue. Noom presents the drugs as a kind of superpower weight-loss tool, which the company said then drives customers to other parts of its platform. 'In the last month or two, people who are taking the meds are actually logging more meals,' said Noom's CEO. 'They're weighing in more and they're engaging in the other aspects of the Noom programme at a rate that's even better than the flagship programme.' Weight-loss drug bandwagon Other health companies see room for products and services that take advantage of the popularity of new weight-loss drugs, which some analysts forecast will have annual sales of $150bn in the next decade. Health retailer The Vitamin Shoppe has seen a spike in demand for supplements that could help with loss of appetite, decreasing muscle tone, and other GLP-1 side effects, said president Muriel Gonzalez. Sales of a set of supplements marketed to people taking such drugs jumped more than 20% from a year ago, a company spokesperson said. Last year, The Vitamin Shoppe launched a telehealth service, Whole Health Rx, that connects consumers with medical providers who can prescribe weight-loss drugs and recommend supplements to give people protein, fibre and multivitamins while on them. Other companies have made similar moves. Supplement-seller GNC, looking to capitalise on the trend, last year added a section in stores dedicated to GLP-1 users, selling protein powder and fibre. WeightWatchers itself is still trying to pivot. A spokesperson said in a statement that the GLP-1 drugs for weight loss are a growing and essential part of its business. It said its programme works, citing an internal study in which its clinic patients taking GLP-1 drugs lost 21% of their weight and then transitioned to its behavioural programme and lost another 2% after 13 weeks. But easy sales of cheaper versions of the drugs are ending, even as lawsuits remain. The US Food and Drug Administration is blocking sales of cheaper compounded versions of the drugs now that Wegovy and Zepbound and their related diabetes medicines — Ozempic and Mounjaro — are no longer in shortage. Selling cheaper versions of the drugs has been a huge profit driver for these companies, and the loss is an issue, said Morningstar healthcare analyst Karen Andersen. One path forward for wellness companies is to work with brand name drugmakers, Andersen said. 'Companies like Novo, they need partners that have access to patients,' she said. But finding creative ways to partner with key competitors is no small task, she added. 'It will be a rocky path.' Reuters

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