Novo Nordisk is increasing its prospects in weight problems and different metabolic problems by securing rights to an early-clinical engineered peptide whose results comes from activating three receptors — the identical three targets hit by a next-generation weight drug in growth by rival Eli Lilly.
In keeping with deal phrases introduced Monday, Novo Nordisk is paying United Biotechnology $200 million up entrance for world rights to its drug, UBT251. United Biotechnology retains rights to the molecule in China, Hong Kong, Macau, and Taiwan. The Gaungdong, China-based firm may obtain as much as $1.8 billion in milestone funds, plus royalties from gross sales if Novo Nordisk commercializes UBT251.
Novo Nordisk has the market’s top-selling weight problems drug in Wegovy, a product whose essential ingredient is a peptide engineered to imitate the hormone that prompts the GLP-1 receptor. R&D efforts throughout the pharma business are attempting to broaden this method to a number of targets. Novo Nordisk’s pipeline contains clinical-stage medication that hit two targets. UBT251 provides the Danish pharmaceutical big a once-weekly injection that hits three: GLP-1, GIP, and glucagon. In keeping with Novo Nordisk and United Biotechnologies, preclinical testing of this long-acting peptide confirmed potent exercise on all three receptors.
Underneath United Biotechnology, UBT251 just lately accomplished double-blind, placebo-controlled Section 1b medical trial in China. The 12-week examine enrolled 36 individuals randomly assigned to a few totally different dose teams. Within the highest dose group, the businesses mentioned the burden of those that accomplished the trial decreased by a median 15.1% from baseline. By comparability, the common weight within the placebo group elevated 1.5% from baseline. The businesses mentioned the commonest opposed occasions had been gastrointestinal, which is in keeping with different weight problems medicines. These occasions had been characterised as delicate to reasonable in severity.
“The addition of a candidate concentrating on glucagon, in addition to GLP-1 and GIP, will add essential optionality to our medical pipeline, as we glance to develop a broad portfolio of differentiated therapy choices that cater to the varied wants of individuals residing with these extremely prevalent illnesses,” Martin Holst Lange, government vice chairman for growth at Novo Nordisk, mentioned in a ready assertion. “We sit up for constructing on United Biotechnology’s scientific work and additional exploring the potential best-in-class properties of UBT251 throughout cardiometabolic illness indications.”
In China, UBT251 is being developed for kind 2 diabetes, chubby or weight problems, metabolic dysfunction-associated fatty liver illness, and power kidney illness. The drug is cleared to enter medical testing within the U.S. in kind 2 diabetes in adults, chubby or weight problems, and power kidney illness.
Lilly’s candidate to activate the GLP-1, GIP, and glucagon receptors is an engineered peptide named retatrutide. Acknowledging the caveats that include cross-trial comparisons, Section 2 outcomes of this weekly injectable drug confirmed a median 17.5% discount in physique weight from baseline measured after 24 weeks. After 48 weeks, the common weight discount was 24.2%.
Novo Nordisk’s deal for the United Biotechnology drug provides it one other strive at drugging three targets in single metabolic drug. In a be aware despatched to buyers, William Blair analysts famous that the pharma big discontinued growth of a triple agonist for power weight administration in 2020 as a result of firm’s medical success from pairing Wegovy and cagrilintide, a peptide engineered to focus on the amylin receptor. Additionally, the triple agonist didn’t attain the specified goal profile.
Mid-stage knowledge posted by Lilly’s retatrutide in 2023 revived curiosity in weight problems medication that hit three targets, the William Blair analysts mentioned. However retatrutide’s outcomes additionally confirmed extra extreme and frequent opposed occasions in comparison with permitted medication, equivalent to Lilly’s personal Zepbound. These negative effects embody increased measures of hypersensitivity, antidrug antibodies, and cardiac arrhythmia.
Retatrutide’s outcomes to this point depart a chance for firms creating triple-acting weight problems medication to distinguish on security. That mentioned, William Blair believes dual-acting weight problems medication supply the broadest medical utility. Triple agonists may gain advantage sufferers with excessive physique mass indexes. Retatrutide is anticipated to put up preliminary knowledge in weight problems and kind 2 diabetes in 2026.
There are different firms creating medication that hit GLP-1, GIP, and glucagon receptors to set off weight reduction. Kailera Therapeutics launched final fall with $400 million and 4 in-licensed Jiangsu Hengrui Prescription drugs drug candidates, together with one which hits these three targets. The pipeline of Metsera, which raised $275 million from its IPO final month, features a long-acting peptide engineered to bind to and activate the three targets.
Novo Nordisk Expands Discounted Wegovy Value to Brick-and-Mortar Pharmacies
When Novo Nordisk earlier this month unveiled a reduced value for Wegovy out there to eligible sufferers who order by means of a brand new on-line pharmacy, the drugmaker mentioned this lower cost would broaden “within the close to future” to those that use conventional pharmacies. That change is going on now.
Novo Nordisk mentioned Monday that each one cash-paying sufferers who use Wegovy will be capable of get hold of the once-weekly injectable weight problems drug from brick-and-mortar pharmacies for $499 per 30 days, the identical value for the drug by means of its new NovoCare on-line pharmacy, which ships the drug on to sufferers’ houses. That value is a steep low cost from the $1,349 checklist value for a month’s provide of the drug, a product administered in single-use, pre-filled injection pens.
The brand new decrease money value for Wegovy covers all doses of the drug. As with the web providing, discounted Wegovy is offered to uninsured sufferers who pay money for his or her medicines in addition to insured sufferers whose protection doesn’t embody weight problems medication. Novo Nordisk mentioned this up to date supply replaces a earlier financial savings supply that supplied Wegovy to cash-paying sufferers for $650 per 30 days. Sufferers who’re enrolled in Medicare or Medicaid are ineligible for these gives.
Novo Nordisk’s launch of lower-cost Wegovy adopted Eli Lilly’s direct-to-consumer transfer with its weight problems drug, Zepbound. Final summer season, Lilly introduced eligible cash-paying sufferers may get hold of Zepbound by means of the corporate’s digital well being platform, LillyDirect.
The discounted choices for cash-pay sufferers give each Lilly and Novo a technique to hold market share from going to compounding pharmacies. Compounding pharmacies could promote their model of a marketed drug when that product is in scarcity. Compounded medication should not examined in medical trials, nor are they permitted by the FDA. With the FDA just lately declaring shortages resolved for Zepbound and Wegovy, compounding pharmacies should cease promoting their variations of those medication, although they could proceed to supply compounded drug if a affected person wants a dose degree unavailable in a branded product.
Compounders are suing the FDA, claiming that shortages persist and the company’s declarations that the shortages are over had been performed with out due course of. Each Lilly and Novo contend that providing their respective medication on to sufferers can keep away from what they are saying are the security dangers of compounded medication. However the brand new discounted costs for Wegovy and Zepbound are nonetheless increased than the costs of compounded variations.
Photograph: Peter Dazeley, Getty Photos
