Cagrilintide

Novo Nordisk's flagship obesity treatment Wegovy returned to forecast-topping growth in the company's latest financial results, sending shares up more than 8% on Wednesday. Sales of the GLP-1 product surged 79% in the third quarter to DKK 17.3 billion ($2.5 billion), well above consensus expectations of DKK 15.9 billion.While sales of Wegovy had grown 55% in the previous quarter to DKK 11.7 billion, they came in below consensus estimates of DKK 13.5 billion — a "blip" that Novo attributed to an adjustment of rebates related to estimates made on the prior year's revenue.And ahead of Novo's latest financial print, fears of a repeat in the third quarter had been stoked by Eli Lilly's disappointing sales figures for its competing GLP-1/GIP co-agonist products Mounjaro and Zepbound. Revenue for the two came in below analyst predictions, which Lilly blamed on inventory decreases in the US wholesaler channel. On Wednesday, Novo CEO Lars Fruergaard Jørgensen said that the pharma continues to see "very significant demand" for Wegovy in the US and is working hard to increase manufacturing capacity. However, the company warned that despite earmarking billions of dollars to invest in production, it still faces "capacity limitations" at some sites, along with "periodic supply constraints and related drug-shortage notifications."Weak diabetes sales"Wegovy continues to gain momentum and clearly exceeds expectations in the quarter," compensating for weaker diabetes sales, remarked Sydbank analyst Søren Løntoft Hansen. "This is good enough to provide some relief," added Emily Field of Barclays, explaining that Wegovy's beat came despite slightly worse pricing in the US than anticipated.Novo's overall sales and profit both increased 21% in the third quarter to DKK 71.3 billion and DKK 27.3 billion, respectively. However, the revenue figure came in below analyst projections of DKK 72.3 billion, partly due to lacklustre growth in its diabetes segment, including for Ozempic.In the quarter, Ozempic — which contains the same active ingredient as Wegovy — generated sales of DKK 29.8 billion, up 26% year-over-year at constant currencies, but below forecasts of DKK 30.5 billion.Guidance narrowedFor the full year, Novo said it now expects sales growth of between 23% and 27% on a constant exchange rate basis, narrowed from a prior range of 22% to 28%. Meanwhile, operating profit growth was similarly revised, and is now seen between 21% and 27%, from previous guidance of 20% to 28%.Investors had feared the drugmaker would cut its outlook, noted Terence McManus of Bellevue Asset Management. "However, we don't see these results as an all-clear signal on the stock," he added, with all eyes now set to turn to pending late-stage data for its next obesity hopeful dubbed CagriSema.The therapy, which combines semaglutide — the active ingredient in Ozempic and Wegovy — with the amylin analogue cagrilintide, is expected to lead to weight loss of over 15% when results are unveiled later this year. Martin Holst Lange, Novo's development head, reaffirmed that CagriSema has potential for up to 25% weight loss, with "no change in our confidence level."Other pipeline updatesNovo also disclosed alongside its financial print that the Phase IIIb STRIDE study of Ozempic as an adjunct to standard of care in people with type 2 diabetes and peripheral arterial disease with intermittent claudication met its primary endpoint. The drug demonstrated a clinically relevant and statistically significant improvement in maximum walking distance of 13% compared to placebo. US and EU marketing applications in this indication are targeted for the first half of 2025.Additionally, the company plans regulatory filings next year for its factor VIIIa mimetic bispecific antibody Mim8 in haemophilia A. Following up on the positive Phase IIIa FRONTIER 2 trial, Novo said Wednesday that the Phase IIIb FRONTIER 5 study has now been completed. The trial assessed switching from prophylaxis with Roche's once-weekly therapy Hemlibra (emicizumab) to Mim8 — something Novo reported was well tolerated.Elsewhere, Novo said it has now decided to bin development of the non-steroidal mineralocorticoid receptor antagonist ocedurenone across all indications. The future of the asset — gained from KBP Biosciences for up to $1.3 billion — was under review following the failure in June of the Phase III CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease.($1 = DKK 6.92889)

In order to maintain its leading position in the weight loss drug market, Novo Nordisk is currently actively developing a new GLP-1 drug called CagriSema, according to the latest media reports. It is reported that the new drug is expected to achieve at least 25% weight loss, compared to the previous generation of weight loss drug Wegovy, CagriSema will be significantly more effective in weight loss, without additional side effects. Novo Nordisk said CagriSema will effectively address the problem of patients regaining weight after discontinuing the drug and is expected to be the most effective weight loss drug on the market to date. In addition, the efficacy of the drug against type 2 diabetes is still being further explored and studied. Novo Nord's planned CagriSema combines two intestinal hormones: a long-acting GLP-1 receptor agonist, Smaglutide, and a long-acting Amylin analogue, Cagrilintide. The combination of these two ingredients is expected to lead to more significant weight loss for patients, while reducing the occurrence of side effects. Matthias Tschop, CEO of the Helmholtz Institute in Munich and one of the scientists behind the multi-receptor therapy foundation, says that patients taking this double-acting drug are often able to lose more weight without suffering more side effects than those taking GLP-1 alone. That view is echoed by Henrik Sillesen, chief medical officer at health analytics firm Airfinity Ltd. Henrik Sillesen noted that after GLP-1, GIP and glucagon, amylin has become the next important target that is actively being explored in the field of weight loss. Adam Steensberg, chief executive of Zealand, also said that taking amylin is gentler than GLP-1 drugs, and that GLP-1 drugs may reduce appetite, while amylin will help patients stay full for longer. This view further highlights the potential advantages of CagriSema in the weight loss drug market.