Novo Slumps as Study on Victoza’s Heart Impact Disappoints

  • Leader trial finds 22 percent fewer deaths from heart disease
  • Victoza fails to keep pace with expectations, Lilly’s drug

Novo Nordisk A/S slumped after its diabetes drug Victoza showed a smaller benefit than analysts had expected in reducing the risk of heart attacks, strokes and deaths from cardiovascular causes.

Some analysts were anticipating a benefit of 15 percent or more, rather than the 13 percent researchers found, after the Danish drugmaker said in March that the study known as Leader beat its initial goal. The stock fell as much as 5.2 percent, the most in more than four months, in Copenhagen trading. At 11:33 a.m. local time, it was down 4.9 percent to 345.60 kroner.

It’s the second study to show a heart benefit for a medicine used to lower blood sugar in diabetics -- a critical finding since heart disease is the group’s leading cause of death. Last year, Eli Lilly & Co. and Boehringer Ingelheim GmbH said their pill Jardiance reduced the risk of heart attacks, strokes and death from heart disease by 14 percent, with a 38 percent reduction in cardiovascular deaths.

“We are underwhelmed,” Jo Walton, an analyst at Credit Suisse Group AG, said in a note to clients. The magnitude of the benefit “was below our expectations and we believe those of investors and doctors we spoke to,” she wrote.

Novo’s treatment was expected to show a better result than Jardiance, according to Walton. The study results don’t argue in favor of prescribing Victoza to patients earlier in the course of the disease, she wrote.

Fewer Deaths

The study also found that patients given Victoza injections were 22 percent less likely to die from heart disease and had a lower overall death rate from any cause than those who were given a placebo, a significant benefit for the 1 million patients taking the medicine. It tracked 9,340 patients for a mean of 3.8 years, and the results were published in the New England Journal of Medicine and presented at the American Diabetes Association’s annual meeting in New Orleans on Monday.

The Novo study was originally conducted to rule out an increase in heart complications with the medicine, also known as liraglutide, which generated $2.68 billion for Bagsvaerd, Denmark-based Novo last year. The studies are required by U.S. regulators for all diabetes treatments after suggestions of risk were seen with GlaxoSmithKline Plc’s Avandia.

“Our results should give patients and providers comfort that liraglutide can safely improve outcomes beyond the core treatment of type 2 diabetes,” said lead author John Buse, from the University of North Carolina School of Medicine. “In addition, liraglutide reduced the risk of the most serious complications associated with type 2 diabetes, including the risk of death.”

Key Result

One striking finding was the breadth and consistency of the benefit across different cardiac events, suggesting that the drug may modify the progression of heart disease, the researchers said. Other medicines across various treatment classes have a similar improvements in blood sugar control, without a related drop in heart disease risk, the researchers said, pointing specifically to a direct rival in the GLP-1 class, Sanofi’s lixisenatide.

More patients taking Victoza quit taking the medicine because of side effects, though rates of pancreatitis were numerically lower. Gallstones were more common in patients getting the injection. Cancers originating in the pancreas were also more slightly more common, though the difference wasn’t statistically significant and the study wasn’t designed to look at cancer risk, the researchers said.

Novo Chief Scientific Officer Mads Krogsgaard Thomsen said the company didn’t anticipate getting such a strong result. It was particularly striking how quickly the benefit appeared, he said. The findings should boost the number of patients taking Victoza and lead doctors to start prescribing it earlier, he said.

“It’s the profile of a true cardiovascular drug, by which I mean all the things you are looking at -- heart attack, stroke, death -- everything points to intervening in the process that leads to cardiovascular disease,” Thomsen said. “This is something that should be used as early as possible because then you can reap the benefits longer.”

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