CagriSema

Zealand Pharma has finally found a partner. And according to the Danish company, the licensing deal it announced with Roche on Wednesday for its amylin analog petrelintide is the biggest ever for an obesity candidate to date. The companies said the Swiss pharma is paying Zealand $1.65 billion upfront in cash. $1.4 billion of that will be given once the deal is closed, which is expected to be in the second quarter of this year, and $250 million over the next two years every time the partnership celebrates an anniversary. Importantly, Roche and Zealand will also investigate petrelintide combinations. The first on the list for co-administration is Roche’s GLP-1/GIP agonist candidate CT-388, which Roche obtained from its acquisition of Carmot Therapeutics in late 2023. CT-388 has shown effectiveness in early trials but had high rates of gastrointestinal side effects; combining it with amylin could allow a more potent weight loss effect, allowing lower, safer doses. The ghost at the feast is Novo Nordisk’s amylin-incretin combo CagriSema, which has disappointed in late-stage trials in patients with obesity and with obesity and diabetes . CEO Adam Steensberg told Endpoints News in an interview that Zealand can do better. CagriSema combines equal 2.4 mg doses of Novo’s amylin analog cagrilintide and GLP-1 semaglutide, and Steensberg suggests this ratio is “suboptimal.” “We think you need to max out on amylin … then just add a little bit of GLP-1/GIP on top,” he said. In Zealand’s ongoing Phase 2b monotherapy trial in obese patients, petrelintide is being dosed at up to 9 mg . Data from this trial are due by mid-2026. Steensberg said that having Roche on board as a partner does not alter its plans for Phase 3 trials of petrelintide, but could accelerate them. “We look very much forward to also having their input into the details of the program,” he said. “The key focus will be on obesity as a first indication, with an ambition of rapidly expanding into additional indications,” Steensberg said. These are yet to be confirmed, but he did not rule out research in diabetes and the liver disorder MASH. Zealand believes that petrelintide monotherapy and the incretin combo will eventually be used to treat different populations. The former “will be a product for the majority of obese individuals,” Steensberg said, whereas “the most morbidly obese patients, they could benefit from a combination therapy.” The combo could also be of use in patients with both obesity and type 2 diabetes. On Zealand’s side, the collaboration is strictly on petrelintide — its other obesity candidates, such as the GLP-1/GLP-2 drug dapiglutide, are not involved. But other injected Roche assets might be used in future combinations, Steensberg said. Roche’s weight loss portfolio mainly stems from its $2.7 billion acquisition of Carmot. Roche has another GLP-1/GIP agonist, CT-868, and one of the brightest oral obesity hopes, a pill called CT-996. The company also has an anti-latent myostatin product called GYM329. Including milestone payments, the companies estimate the deal to be worth up to $5.3 billion. As part of the deal, Zealand will pay Roche $350 million for its share in studying CT-388 as a combo with petrelintide. The companies said they will split revenues — and losses — on their first monotherapy and combo drugs on a “50/50 basis” in the US and Europe. Steensberg described the profit share as the “true value” of the deal. Zealand could get royalties on net sales in other countries. Another major aspect of this deal is Roche’s manufacturing network and commercial reach. With the leading weight loss drug companies Eli Lilly and Novo Nordisk having to find ways to scale up manufacturing quickly, others yet to enter the market are mapping out commercial production plans much earlier in the process. Zealand has not been shy in declaring it was looking for a partner to study and commercialize its lead weight loss candidate. It has been on the hunt for a year or so now, and three weeks ago Steensberg told Endpoints the biotech was “exactly where we want to be.” Zealand is up 35% on the Danish stock exchange. Additional reporting by Reynald Castaneda. Editor’s note: This article has been updated throughout after an interview with Zealand CEO Adam Steensberg and stock reaction.

Novo Nordisk's latest trial results for its next-generation diabetes drug, CagriSema, have revealed a 15.7% weight loss in overweight or obese patients with type 2 diabetes after 68 weeks of treatment. However, despite these promising findings, the company's shares fell by 5% following the announcement, indicating investor disappointment over the results. The trial, known as REDEFINE 2, involved around 1,200 participants and aimed to assess whether CagriSema could outperform Novo's existing blockbuster medications, Ozempic and Wegovy. The drop in share price reflects concerns that the weight loss achieved was lower than anticipated, especially after another disappointing trial for CagriSema earlier in December. CagriSema is a weekly injection that combines semaglutide—the active ingredient in Wegovy—with a molecule called cagrilintide, which mimics the pancreatic hormone amylin. This combination works to suppress hunger and regulate blood glucose levels. Notably, 61.9% of the trial participants were on the highest dose after the treatment period. While the weight loss results are significant, the market's reaction underscores the high expectations set for this innovative treatment. As the competitive landscape in diabetes and obesity medications continues to evolve, Novo Nordisk faces challenges in maintaining investor confidence amidst fluctuating trial outcomes.