Latest news with #MochiHealth
Yahoo
07-05-2025
- Business
- Yahoo
Novo Nordisk cuts 2025 outlook due to compounding-hit Wegovy demand
Novo Nordisk has reduced its sales and profits forecasts for 2025 due to lower-than-expected demand in the US for blockbuster weight loss and diabetes drugs, though shares in the company were still up following positive Q1 results. Despite feeling the effects from the compounded glucagon-like peptide 1 receptor agonist (GLP-1RA) market, Novo Nordisk is still growing at a fast pace. Total revenues for the company came in at DKr78.1bn ($11.9bn) for Q1 2025, up 18% at constant exchange rates from the same period last year. Operating profit increased by 20%, reaching DKr38.8bn. Whilst the share price in the Copenhagen-listed company opened relatively unchanged to a pre-earnings release market close, the stock crept up 5.8% by mid-morning today (7 May). Novo Nordisk's market cap of DKr1.56tn is the second largest in Europe. The Danish pharma company's diabetes and obesity care business made up the bulk of total revenue. Sales for the unit, headed by GLP-1RA treatments Wegovy (semaglutide) and Ozempic (semaglutide) for weight loss and type 2 diabetes, respectively, reached DKr73.5bn. Novo Nordisk stated that obesity sales were the main driver – up 65% compared to Q1 2024. Diabetes sales were up a more modest 11%, with the market not as big as its burgeoning obesity counterpart. When it comes to its total 2025 outlook, Novo Nordisk does not think it will reach its previously anticipated target. The company cut its sales growth to a range of 13-21%, compared to earlier guidance of 16-24%. Operating profit growth is forecast at 16-24%, also down from a previous range of 19-27%, the company said. The reason, Novo Nordisk stated, was 'lower-than-planned penetration of branded GLP-1RA treatments in the US, impacted by compounded GLP-1RAs'. Compounding pharmacies were allowed to produce vast quantities of semaglutide copies when Novo Nordisk's branded drugs were in short supply starting in early 2022. Compounded drugs are custom-made and unbranded medications that contain the same active ingredient as a marketed drug, such as semaglutide, under a prescription. Several telehealth companies such as Mochi Health and Hims & Hers began to offer compounded semaglutide during the shortage, significantly growing their customer base in this time. Their growth in popularity has meant an erosion of market share in the obesity sector for Novo Nordisk. The Danish company has now formed a partnership to provide Him & Hers customers access to the NovoCare Pharmacy. Novo Nordsik's CEO Lars Fruergaard Jørgensen said: "In the first quarter of 2025, we delivered 18% sales growth and continued to expand the reach of our innovative GLP-1 treatments. However, we have reduced our full-year outlook due to lower-than-planned branded GLP-1 penetration, which is impacted by the rapid expansion of compounding in the US.'
Yahoo
23-04-2025
- Health
- Yahoo
Eli Lilly sues telehealth companies selling compounded Zepbound, Mounjaro
Eli Lilly is suing four telemedicine companies selling compounded versions of its blockbuster obesity drug Zepbound and its diabetes treatment Mounjaro, escalating its battle against unauthorized sellers, manufacturers and distributors of copycat versions of the medicine. In lawsuits filed Wednesday in the U.S. District Court for the Northern District of California, Lilly accused the sites — Mochi Health, Fella Health, Willow Health and Henry Meds — of deceiving consumers about 'untested, unapproved drugs.' Lilly also alleged some of the sites are selling versions of the drugs that haven't been studied, such as oral tablets and drops. For instance, Henry Meds sells what it claims is an oral version of tirzepatide, the active ingredient in Lilly's drugs. But Lilly in the lawsuit argued the oral version 'is an untested knockoff that exposes patients to safety risks' because no clinical study has found tirzepatide taken orally is safe and effective. 'Lilly's tirzepatide medicines are only tested and approved for under-the-skin injections— not for administration in any oral form,' the company wrote. In a new approach, Lilly also accused Mochi and Fella of engaging in the corporate practice of medicine. The lawsuit claims neither company is owned by a physician, and that the telehealth companies exert influence and control over their supposedly 'independent' affiliated medical groups. Fella Health, which also operates a brand called Delilah for women, is affiliated with Fella Medical Group, while Mochi Health is affiliated with Mochi Medical, according to the lawsuits. In its filing, Lilly claimed Mochi CEO Myra Ahmad is not a licensed physician 'Mochi Health and its unlicensed owners exercise undue influence and control over, among other things, the prescribing decisions of physicians at Mochi Medical—and, as a result, engage in, and aid and abet, the unlawful corporate practice of medicine,' Lilly said in its complaint against Mochi. In its complaint against Fella Health, Lilly said the company made 'sweeping corporate decisions that dictate patient care, such as when Fella changed patients en masse from one tirzepatide formulation to another with additives.' Compounders had been allowed to produce and sell hundreds of thousands of their own versions of popular anti-obesity drugs, so long as the FDA considered them in shortage. Compounded drugs are sold at vastly lower prices than the branded versions, but drug companies and some obesity specialists have expressed concerns that compounded products aren't safe because they are not FDA-approved. Lilly's diabetes drug Mounjaro went into short supply in late 2022, though the FDA has since declared the shortage over, meaning mass compounding was supposed to stop. But some compounders have argued they can continue marketing the drugs if they are administered in nonstandard doses, and if the compounded drugs are prescribed by a health care provider to meet a clinical need. Lilly argued that Fella and Mochi Fella 'unilaterally' changed the prescriptions for compounded tirzepatide. Fella allegedly required patients to take doses manipulated with additives, while Mochi changed from doses similar to Lilly's to lower doses 'that have never been studied.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
23-04-2025
- Health
- The Hill
Eli Lilly sues telehealth companies selling compounded Zepbound, Mounjaro
Eli Lilly is suing four telemedicine companies selling compounded versions of its blockbuster obesity drug Zepbound and its diabetes treatment Mounjaro, escalating its battle against unauthorized sellers, manufacturers and distributors of copycat versions of the medicine. In lawsuits filed Wednesday in the U.S. District Court for the Northern District of California, Lilly accused the sites — Mochi Health, Fella Health, Willow Health and Henry Meds—of deceiving consumers about 'untested, unapproved drugs.' Lilly also alleged some of the sites are selling versions of the drugs that haven't been studied, such as oral tablets and drops. For instance, Henry Meds sells what it claims is an oral version of tirzepatide, the active ingredient in Lilly's drugs. But Lilly in the lawsuit argued the oral version 'is an untested knockoff that exposes patients to safety risks' because no clinical study has found tirzepatide taken orally is safe and effective. 'Lilly's tirzepatide medicines are only tested and approved for under-the-skin injections— not for administration in any oral form,' the company wrote. In a new approach, Lilly also accused Mochi and Fella of engaging in the corporate practice of medicine. The lawsuit claims neither company is owned by a physician, and that the telehealth companies exert influence and control over their supposedly 'independent' affiliated medical groups. Fella Health, which also operates a brand called Delilah for women, is affiliated with Fella Medical Group, while Mochi Health is affiliated with Mochi Medical, according to the lawsuits. In its filing, Lilly claimed Mochi CEO Myra Ahmad is not a licensed physician 'Mochi Health and its unlicensed owners exercise undue influence and control over, among other things, the prescribing decisions of physicians at Mochi Medical—and, as a result, engage in, and aid and abet, the unlawful corporate practice of medicine,' Lilly said in its complaint against Mochi. In its complaint against Fella Health, Lilly said the company made 'sweeping corporate decisions that dictate patient care, such as when Fella changed patients en masse from one tirzepatide formulation to another with additives.' Compounders had been allowed to produce and sell hundreds of thousands of their own versions of popular anti-obesity drugs, so long as the FDA considered them in shortage. Compounded drugs are sold at vastly lower prices than the branded versions, but drug companies and some obesity specialists have expressed concerns that compounded products aren't safe, because they are not FDA-approved. Lilly's diabetes drug Mounjaro went into short supply in late 2022, though the FDA has since declared the shortage over, meaning mass compounding was supposed to stop. But some compounders have argued they can continue marketing the drugs if they are administered in non-standard doses, and if the compounded drugs are prescribed by a health care provider to meet a clinical need. Lilly argued that Fella and Mochi Fella 'unilaterally' changed the prescriptions for compounded tirzepatide. Fella allegedly required patients to take doses manipulated with additives, while Mochi changed from doses similar to Lilly's to lower doses 'that have never been studied.'
Yahoo
23-04-2025
- Business
- Yahoo
Eli Lilly sues telehealth companies for selling Mounjaro, Zepbound compounds
April 23 (UPI) -- Eli Lilly Wednesday filed lawsuits against four telehealth companies alleging they are deceiving consumers by selling compounds of slightly-different versions of Lilly drugs. Lilly is suing Mochi Health, Henry Meds, Willow Health and Fella Health, claiming they are illegally selling compounded versions of tirzepatide. Lilly's suits argue that the knock-off tirzepatide compounds are not really personalized since they are mass-produced and prescribed to many patients. Tirzepatide is the active ingredient in Lilly weight-loss drug Zepbound and the diabetes drug Mounjaro. The suits claim the companies are allegedly deceiving customers and turning consumers away from the Lilly-branded medicines. The compounding of Mounjaro happened in 2022 when a shortage of the drug allowed pharmacies and other facilities to produce compounds of the pharmaceutical. Lilly brought in $16.4 billion in revenue last year from Zepbound and Mounjaro. The sued companies did not immediately respond directly to the lawsuits, but Mochi Health told Wired in a general statement that compounded medications are customized by Mochi for "medical necessity." "Their use remains appropriate and legal when tailored to individual patient needs and prescribed by a licensed medical provider-not as mass-market substitutes for branded medications," Mochi's statement said. Mochi Health CEO Myra Ahmad told CNBC in March it planned to keep selling compounded versions of tirzepatide. Lilly's suits against the telehealth companies seeks to prevent them from selling or marketing their versions of tirzepatide. Lilly alleged the companies are mass-marketing slightly different versions of Lilly drugs to get around Food and Drug Administration rules. The suits filed Wednesday are the latest in an ongoing battle Lilly is waging against the compounding of its pharmaceuticals. In a September 2023 statement referencing its lawsuits against compounders, Lilly said it "filed this lawsuit to protect patients. "Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product," it said. Before Wednesday's lawsuits, Lilly had sued over a dozen pharmacies, medical spas and wellness centers for selling compounds of tirzepatide.
WIRED
23-04-2025
- Health
- WIRED
Eli Lilly Sues 4 GLP-1 Telehealth Startups, Escalating War on Knockoff Drugs
Apr 23, 2025 5:00 AM Pharmaceutical giant Eli Lilly alleges the companies are selling off-brand versions of its best-selling diabetes and weight-loss drugs, Mounjaro and Zepbound. Eli Lilly headquarters in Indianapolis, Indiana. Photograph:On Wednesday, pharmaceutical giant Eli Lilly sued four prominent telehealth companies that offer more affordable, off-brand versions of its patented best-selling GLP-1 medications Mounjaro and Zepbound. Together, the drugs accounted for over $16.4 billion in revenue for the company last year. It's the latest escalation in an ongoing war between the drug industry and health care providers over what are widely seen as the most effective—and lucrative—drugs for treating obesity and diabetes to come on the market in years. The lawsuits target four telehealth brands, Mochi Health, Fella & Delilah Health, Willow Health, and Henry Meds. Eli Lilly alleges that each company is selling knockoffs of its drugs, in some cases, with untested added ingredients like vitamins and amino acids in an attempt to distinguish them from its name-brand medications. None of the companies named as defendants immediately responded to requests for comment from WIRED about the lawsuits. In response to general questions about its business practices, Mochi Health said in a statement that it offers compounded GLP-1 medications that are 'customized for medical necessity." 'Their use remains appropriate and legal when tailored to individual patient needs and prescribed by a licensed medical provider—not as mass-market substitutes for branded medications,' Mochi Health said. Fella & Delilah Health, Willow Health, and Henry Meds did not respond to questions about its business practices in time for publication. Lilly previously filed other lawsuits against more than a dozen compounding pharmacies, medical spas, and wellness centers for selling drugs claiming to contain tirzepatide, the active ingredient in both Zepbound and Mounjaro. Mounjaro surged in popularity after it was approved to treat diabetes in May 2022, and the FDA declared some doses of it were in shortage by the end of that year. Zepbound was approved as an obesity treatment in November 2023, with certain doses going into short supply months later. (Novo Nordisk's competing GLP-1 medications, Ozempic and Wegovy, also went into shortage in 2022.) When there's an official shortage of a drug, compounding pharmacies are legally allowed to create duplicate copies or custom-mixed approximations known as 'compounds' to meet patient needs. These off-brand versions are not approved by the FDA—but they are often far more affordable than name-brand medications. During the years-long tirzepatide and semaglutide shortages, which the FDA officially declared over in December and February, compounded GLP-1s became widely available through existing telehealth providers and startups that sprang up specifically to cash in on the new, lucrative health care niche. According to a trade group representing compounders, at least 2 million people in the US were taking these medications as of November last year. Some telehealth companies offered vials of tirzepatide for under $100, a fraction of the cost of Mounjaro and Zepbound, and shipped them to patients within days after they filled out a quick online questionnaire. While most telehealth brands and compounding pharmacies do not disclose their revenue, industry juggernaut Hims said during a recent earnings call that it brought in about $225 million from GLP-1 drug sales last year. (Hims no longer sells compounded tirzepatide, but recently added branded Zepbound to its offerings.) The FDA gave compounders a grace period to wind down their production of the drugs after the shortage was over. Small pharmacies had until February 18 to comply, while larger outsourcing facilities had until March 19. (Semaglutide compounders were ordered to cease mass production this spring, with smaller compounders given a deadline of April 22 and outsourcing facilities given until May 22.) While many compounding pharmacies and telehealth providers have halted production and sales, others have continued to offer tirzepatide products with add-on ingredients, unapproved dosages, or in different forms, such as oral versions. 'It's a minority,' says Jayne Hornung, chief clinical officer at the pharmaceutical analytics company MMIT. Hornung says that companies continuing to sell tirzepatide are hoping the vitamin additives and other tweaks will allow them to argue they aren't selling straightforward copies of Lilly's patented drugs. 'They're getting very creative,' she says. Compounding pharmacies are generally permitted to create customized medicines for patients even when they're not in shortage, such as for individuals who may be allergic to certain ingredients or need carefully calibrated doses. The crux of Lilly's argument is that, when it comes to tirzepatide, the medications telehealth companies are offering are not truly personalized because they are being mass produced and prescribed to many patients. 'There are some ways that compounders tailor a medication to the patient, such as by adding another ingredient that might help with a side effect or an additional concern or diagnosis,' says Annie Lambert, a pharmacist and clinical program manager at information services firm Wolters Kluwer. 'But there needs to be good science and evidence behind the safety of combining those things." Mass-producing compounded versions of existing drugs with additives was not widespread until recently, according to Nicole Snow, a pharmacist at the compounding company Olympia Pharmaceuticals, which previously produced compounded tirzepatide but stopped after the shortage ended and never included additives. 'We'd seen it from time to time, but not in this magnitude,' she says. 'It wasn't a very popular thing until we got into GLP-1s.' In its suit against Mochi, Eli Lilly claims the telehealth company 'switched dosages and prescriptions for patients en masse at least five times—with corporate interests, rather than doctor decisionmaking—driving the changes.' Those changes, Lilly alleges, included creating two new formulas containing a niacinamide additive and pyridoxine, both forms of vitamin B that the pharma company argues have not been proven to be safe or effective when combined with tirzepatide. Mochi's own compounder, Aequita Pharmacy, made some of those products. In March, regulators in Washington state ordered production to be halted at Aequita Pharmacy, citing safety violations connected to GLP-1 medications. In another lawsuit filed in the same California court, Lilly claims that Fella & Delilah Health switched all of its patients from a compounded tirzepatide product with no additives to a version containing untested amino acid additives late last year. The pharmaceutical giant's lawsuit against Henry Meds, which offers oral and injectable GLP-1 medications, accuses the company of 'creating the false impression' that clinical trials have confirmed the effectiveness of its drugs, 'materially omitting that no such clinical trial data exists.' Lilly's lawsuit against Willow Health Services alleges that the Texas-based telehealth company falsely markets some of its products, such as an oral droplet GLP-1 drug and a version of compounded tirzepatide with added niacinamide added, as 'custom-prepared' for patients despite being mass-produced. Some companies selling compounded GLP-1 meds are unlikely to stop without a fight. A compounding trade group has filed a set of lawsuits against the FDA on behalf of clients, arguing that the agency prematurely declared the GLP-1 shortages over. Whether or not their legal efforts are successful, there's still a possibility that the drugs could once again go into shortage if demand continues to rise. As new research continues to point to additional medical uses for these drugs, that may very well happen. 'Pharmacies compound medication all the time, and there are no lawsuits about it because they're not trying to compete with drug companies,' Lambert says. 'This is so contentious because there's so much money at stake.'
