Retatrutide

Novo Nordisk is expanding its prospects in obesity and other metabolic disorders by securing rights to an early-clinical engineered peptide whose effects comes from activating three receptors — the same three targets hit by a next-generation weight drug in development by rival Eli Lilly. According to deal terms announced Monday, Novo Nordisk is paying United Biotechnology $200 million up front for global rights to its drug, UBT251. United Biotechnology retains rights to the molecule in China, Hong Kong, Macau, and Taiwan. The Gaungdong, China-based company could receive up to $1.8 billion in milestone payments, plus royalties from sales if Novo Nordisk commercializes UBT251. Novo Nordisk has the market’s top-selling obesity drug in Wegovy, a product whose main ingredient is a peptide engineered to mimic the hormone that activates the GLP-1 receptor. R&D efforts across the pharma industry are trying to expand this approach to multiple targets. Novo Nordisk’s pipeline includes clinical-stage drugs that hit two targets. UBT251 gives the Danish pharmaceutical giant a once-weekly injection that hits three: GLP-1, GIP, and glucagon. According to Novo Nordisk and United Biotechnologies, preclinical testing of this long-acting peptide showed potent activity on all three receptors. presented by Health Tech The 5 Best Software to Buy for Managing a Spa Franchise Choosing the right software translates directly into better client management, operational efficiency and growth for your spa franchise. Discover which tool is best for your business. By Meevo Under United Biotechnology, UBT251 recently completed double-blind, placebo-controlled Phase 1b clinical trial in China. The 12-week study enrolled 36 participants randomly assigned to three different dose groups. In the highest dose group, the companies said the weight of those who completed the trial decreased by an average 15.1% from baseline. By comparison, the average weight in the placebo group increased 1.5% from baseline. The companies said the most common adverse events were gastrointestinal, which is consistent with other obesity medications. These events were characterized as mild to moderate in severity. “The addition of a candidate targeting glucagon, as well as GLP-1 and GIP, will add important optionality to our clinical pipeline, as we look to develop a broad portfolio of differentiated treatment options that cater to the diverse needs of people living with these highly prevalent diseases,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in a prepared statement. “We look forward to building on United Biotechnology’s scientific work and further exploring the potential best-in-class properties of UBT251 across cardiometabolic disease indications.” In China, UBT251 is being developed for type 2 diabetes, overweight or obesity, metabolic dysfunction-associated fatty liver disease, and chronic kidney disease. The drug is cleared to enter clinical testing in the U.S. in type 2 diabetes in adults, overweight or obesity, and chronic kidney disease. Lilly’s candidate to activate the GLP-1, GIP, and glucagon receptors is an engineered peptide named retatrutide. Acknowledging the caveats that come with cross-trial comparisons, Phase 2 results of this weekly injectable drug showed an average 17.5% reduction in body weight from baseline measured after 24 weeks. After 48 weeks, the average weight reduction was 24.2%. Sponsored Post A Data-Driven Guide to Patient Access Success A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Novo Nordisk’s deal for the United Biotechnology drug gives it another try at drugging three targets in single metabolic drug. In a note sent to investors, William Blair analysts noted that the pharma giant discontinued development of a triple agonist for chronic weight management in 2020 due to the company’s clinical success from pairing Wegovy and cagrilintide, a peptide engineered to target the amylin receptor. Also, the triple agonist did not reach the desired target profile. Mid-stage data posted by Lilly’s retatrutide in 2023 revived interest in obesity drugs that hit three targets, the William Blair analysts said. But retatrutide’s results also showed more severe and frequent adverse events compared to approved drugs, such as Lilly’s own Zepbound. These side effects include higher measures of hypersensitivity, antidrug antibodies, and cardiac arrhythmia. Retatrutide’s results to date leave an opportunity for companies developing triple-acting obesity drugs to differentiate on safety. That said, William Blair believes dual-acting obesity drugs offer the broadest clinical utility. Triple agonists could benefit patients with high body mass indexes. Retatrutide is expected to post preliminary data in obesity and type 2 diabetes in 2026. There are other companies developing drugs that hit GLP-1, GIP, and glucagon receptors to trigger weight loss. Kailera Therapeutics launched last fall with $400 million and four in-licensed Jiangsu Hengrui Pharmaceuticals drug candidates, including one that hits those three targets. The pipeline of Metsera, which raised $275 million from its IPO last month, includes a long-acting peptide engineered to bind to and activate the three targets. Novo Nordisk Expands Discounted Wegovy Price to Brick-and-Mortar Pharmacies When Novo Nordisk earlier this month unveiled a discounted price for Wegovy available to eligible patients who order through a new online pharmacy, the drugmaker said this lower price would expand “in the near future” to those who use traditional pharmacies. That change is happening now. Novo Nordisk said Monday that all cash-paying patients who use Wegovy will be able to obtain the once-weekly injectable obesity drug from brick-and-mortar pharmacies for $499 per month, the same price for the drug through its new NovoCare online pharmacy, which ships the drug directly to patients’ homes. That price is a steep discount from the $1,349 list price for a month’s supply of the drug, a product administered in single-use, pre-filled injection pens. The new lower cash price for Wegovy covers all doses of the drug. As with the online offering, discounted Wegovy is available to uninsured patients who pay cash for their medicines as well as insured patients whose coverage does not include obesity drugs. Novo Nordisk said this updated offer replaces a previous savings offer that provided Wegovy to cash-paying patients for $650 per month. Patients who are enrolled in Medicare or Medicaid are ineligible for these offers. Novo Nordisk’s launch of lower-cost Wegovy followed Eli Lilly’s direct-to-consumer move with its obesity drug, Zepbound. Last summer, Lilly announced eligible cash-paying patients could obtain Zepbound through the company’s digital health platform, LillyDirect. The discounted offerings for cash-pay patients give both Lilly and Novo a way to keep market share from going to compounding pharmacies. Compounding pharmacies may sell their version of a marketed drug when that product is in shortage. Compounded drugs are not tested in clinical trials, nor are they approved by the FDA. With the FDA recently declaring shortages resolved for Zepbound and Wegovy, compounding pharmacies must stop selling their versions of these drugs, though they may continue to offer compounded drug if a patient needs a dose level unavailable in a branded product. Compounders are suing the FDA, claiming that shortages persist and the agency’s declarations that the shortages are over were done without due process. Both Lilly and Novo contend that offering their respective drugs directly to patients can avoid what they say are the safety risks of compounded drugs. But the new discounted prices for Wegovy and Zepbound are still higher than the prices of compounded versions.

Dive Brief:Novo Nordisk is expanding its pipeline of obesity medicines, announcing Monday it will pay China-based United Laboratories International Holdings $200 million upfront to license an experimental triple agonist weight loss shot that could take on Eli Lillys retatrutide.Per deal terms, Novo will have commercialization rights to the drug outside of China and nearby marketing territories, and could owe up to an additional $1.8 billion based on achievement of certain milestones by the drug, called UBT251. Novo would also pay royalties on sales in its marketing territories.Novo had a big head start in obesity, getting the GLP-1 drug Wegovy to people with obesity five years ahead of Eli Lilly and its medicine Zepbound. But Lilly is catching up quickly, showing in testing that Zepbound helps people lose more weight than Wegovy and closing the sales gap, which stands at $4.9 billion in 2024 to Wegovys $8.4 billion.Dive Insight:Both Novo and Lilly struggled to meet demand for their obesity drugs, forcing them to spend billions of dollars to boost their manufacturing capacity. With that issue now largely resolved, Novo is turning its attention to the competitive landscape, where it is facing a stiff challenge from Lilly and other potential rivals like Amgen, Pfizer, Zealand and Viking Therapeutics.Novo pioneered the use of drugs stimulating a gut hormone called GLP-1 to help people with obesity lose weight. Lilly showed that, by acting on a second one called GIP, Zepbound could improve GLP-1s efficacy. Now drugmakers are experimenting with the use of other related pathways called glucagon and amylin although Novos initial effort in that area, combining GLP-1 and amylin, has underperformed expectations.Lilly is leading in triple-acting drugs, too, with an experimental shot it calls retatrutide that could have Phase 3 results next year. Novo advanced a tri-agonist into Phase 1 trials last year, but with the deal announced today it would have a drug that has already completed a Phase 1 dosing trialThe addition of a candidate targeting glucagon, as well as GLP-1 and GIP, will add important optionality to our clinical pipeline, as we look to develop a broad portfolio of differentiated treatment options that cater to the diverse needs of people living with these highly prevalent diseases, said Martin Holst Lange, Novos executive vice president for development, in a statement.Novo said Uniteds medicine had a similar side effect profile as Wegovy, Zepbound and drugs in the class, and helped people who completed the trial lose 15.1% of their body weight over 12 weeks, compared with a 1.5% increase for people who got placebo.The new tri-agonist will join an already beefy pipeline, which includes the GLP-1/amylin drug CagriSema, for which Novo still has high hopes, a version of its GLP-1 diabetes pill Rybelsus in obesity and various combinations of GLP-1, GIP and amylin. '