Doctors gathered in New Orleans this week for the American Diabetes Association’s annual meeting, but it seemed like most of them wanted to talk about obesity.
Dramatic levels of weight loss are being attained in clinical trials of drugs originally developed for diabetes by companies like Novo Nordisk (ticker: NVO) and Eli Lilly (LLY).
Both companies met stock analysts during the ADA meeting, and the talks focused on the exciting prospects for a new class of drugs called incretins. In a Tuesday meeting, Lilly reviewed a Phase 3 study published over the weekend in the New England Journal of Medicine, in which patients on the highest dose of Lilly’s diabetes drug tirzepatide lost an average of 52 pounds over 18 months.
After a Monday meeting at which Novo said it hoped for even better results with an investigational drug called CagriSema, J.P. Morgan analyst Richard Vosser upgraded the Danish drugmaker from Neutral to Overweight and raised his price target 30%, to $133. Vosser projects that Novo and Lilly will divvy up a market for incretin treatments for obesity that reaches $34 billion by 2031.
Both stocks benefited from the attention. Novo shares rose some 3.6% from a Monday level around $112 to Wednesday’s close of $115.99, despite the backdrop of a flat Nasdaq Composite. Lilly stock rose 3.9% from its Monday open to a Wednesday close of $313.49.
Obesity is a leading risk factor for diabetes, heart disease, and other serious illnesses. Over 40% of the U.S. population is considered obese, with minority groups impacted disproportionally. Drugs haven’t offered much help, and only 3% of patients with obesity get them.
“ADA is about diabetes, and everyone is talking about obesity,” Novo’s head of development, Martin Holst Lange, told his Monday audience. “It makes a lot of sense because as you obviously know, obesity is basically the starting point for Type 2 diabetes in the vast majority of patients.”
Novo was first to market with a June 2021 Food and Drug Administration obesity approval for Wegovy, a once-weekly injectable incretin that boosts a hormone called GLP-1. Production problems at one of the company’s contract manufacturers interrupted marketing, however, and Novo told analysts at this week’s meeting that it will restart U.S. marketing of the drug in the second half of this year.
Wegovy enabled patients to lose about 15% of their body weight. J.P. Morgan’s Vosser thinks the drug’s sales will peak at $5.5 billion in 2025, then lose share to Lilly’s tirzepatide and Novo’s own next-generation drug CagriSema.
On Tuesday, Lilly told analysts that tirzepatide’s highest dose allowed patients to lose an average of 21% of their body weight. Some 40% of treated patients lost 25% or more. Lilly’s once-weekly injectable drug boosts two hormones. Head-to-head against Novo’s Wegovy in the Lilly trial, tirzepatide performed better on most measures. Patients on the Lilly drug lost more fat than muscle, so their lean body mass improved; so did waist circumference, blood pressure, and serum cholesterol. Appetites eased and they ate less.
If the FDA approves the Lilly drug for obesity marketing, tirzepatide could launch in mid-2023. J.P. Morgan analyst Chris Schott rates Lilly at Outperform, and believes the drug will eventually surpass $10 billion in obesity sales, on top of over $12 billion in sales for diabetes.
Novo told analysts that it may conduct its own head-to-head trial, once Lilly’s tirzepatide becomes available. But Novo wants to test it against CagriSema, its own multi-hormone booster. in a 20-week Phase 1 study, the Novo injectable took an average of 17% off patients’ weight. Vosser thinks that longer studies of CagriSema will show the Novo drug with a 24% average loss, outperforming tirzepatide’s 21% average weight loss.
Both companies showed other obesity treatments under testing in their pipelines. Patients and doctors are likely to have many options by the end of this decade.
By Bill Alpert
Source: marketwatch.com
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced several new measures to make it easier to run clinical trials in the country, marking the first time in 20 years the regulatory body has made such an overhaul.
Diabetes drugmaker Novo Nordisk is partnering with Dewpoint Therapeutics in a deal aimed at uncovering new treatments for insulin resistance by targeting cellular droplets known as biomolecular condensates. Dewpoint will receive $55 million upfront from Novo, which plans to develop small molecule drugs against targets discovered using Dewpoint’s technology.
Sanofi has secured approval for Dupixent (dupilumab) from the European Commission (EC) to treat severe atopic dermatitis in children aged six months to five years, who are systemic therapy candidates, in the European Union (EU). This approval makes Dupixent the first and only medicine available in the US and Europe for the treatment of such young children.