Wegovy and Ozempic owner dealt blow as next-gen weight-loss drug is branded ‘obsolete’ | Pharmaceuticals industry
The owner of Wegovy and Ozempic has suffered a significant setback as its highly anticipated new weight loss treatment was labeled “outdated” after disappointing clinical trials.
Shares of Novo Nordisk fell sharply on Monday after test results of the Danish firm’s CallSema drug fell short of investors’ expectations.
The weekly injection combines an amylin analog with GLP-1 to regulate metabolism, suppress appetite, and make users feel full more quickly. This means that CallSema is expected to lead to greater weight loss than Novo’s hugely popular Wegovy and Ozempic GLP-1 shots.
The study was designed to show that ÇağrıSema is at least as good as Novo rival Eli Lilly’s leading anti-obesity drug Zepbound, which contains tirzepatide.
Despite the initial expectation of 25 percent weight loss, ÇağrıSema was disappointing in the latest study involving 809 people. If all people complied with the treatment, an average of 23% weight loss was achieved after 84 weeks, while for tirzepatide this rate was 25.5%.
The new Novo treatment “failed to achieve its primary endpoint of noninferiority of CagriSema compared to tirzepatide in weight loss after 84 weeks,” the company said On Monday.
“It’s like a swing and a miss,” Søren Løntoft Hansen, a senior analyst at AL Sydbank, told Marketwire. He added: “It is difficult to assess whether these data will influence Novo Nordisk’s decision to launch Cagrisema.”
Novo’s share price fell 16% on the news, bringing its losses over the past year to almost 60%; Lilly’s shares rose more than 3% in premarket trading.
Novo, whose sales of weight-loss and diabetes drugs have boomed and made itself Europe’s most valuable company in recent years, lost out to Lilly and cut its profit and sales forecasts several times. Novo was also investing in the new Wegovy pill, as well as ÇağrıSema, to stimulate sales.
Analysts at UBS cut their top sales forecast for Novo’s GLP-1 drugs from $80bn (£59bn) to $75bn in 2032 in January, following earlier disappointing CallSema trial results.
They said of the latest results on Monday: “Significantly negative. A lower result than tirzepatide was very unexpected.”
“We regret the results,” Deutsche Bank’s Emmanuel Papadakis told Novo management on an investor call. “CagriSema now looks a bit outdated as a competitive upgrade to semaglutide or as a competitive alternative to tirzepati.”
Novo CEO Mike Doustdar dismissed the comments, saying: “This is quite insulting, it’s a fantastic drug to be honest. When CağriSema launches as the first amylin-based product early next year, it will have the best weight loss label.” [of] any product being marketed.
Novo hopes that a trial of a higher dose of CallSema will yield better results. It has already submitted the drug to the US drug regulator for approval, based on previous trial evidence, and hopes to get the green light later this year.
