Novo Nordisk builds blockbuster case with promising PhIII obesity data

Mads Krogsgaard Thomsen, Novo chief science officer

In new late-stage data, Novo Nordisk's ($NVO) inaugural obesity drug spurred statistically significant weight loss compared to placebo, bolstering the company's case as it works to build a portfolio of such treatments.

The drug, a higher dose of the blockbuster diabetes treatment liraglutide, is an analog of the hormone GLP-1, which is released after eating and curbs hunger. In the last and largest of its three Phase III trials, Novo enrolled 3,731 obese patients and found that liraglutide helped 92% of subjects lose weight compared to 62% on diet and exercise alone. Patients who completed the 56-week study lost an average of 9.2% of their body weight, significantly beating out the 3.5% with placebo. The liraglutide group also reported significant improvements on three self-reported measures of quality of life.

Those data follow earlier Phase III results in which the drug, to be marketed as Saxenda, helped 60% of obese patients reduce their body weight by at least 5%, with nearly one-third losing more than 10%.

Novo's late-stage package was enough to sway a panel of FDA advisers, who voted 14-1 in favor of approving the injected treatment last month, setting the stage for the company's first launch in the obesity field next year. Liraglutide, marketed at lower doses as Victoza, brought in about $2 billion for Novo last year, and analysts have said an approval in obesity could add as much as $1 billion more to its annual sales.

But Novo's maiden voyage is already behind schedule. The FDA had promised to hand down a final decision on Saxenda by Oct. 20, a date that came and passed with no news. A Novo spokesperson said the company is yet to receive formal feedback from the FDA but noted that "it is not unprecedented that the agency does not revert on the exact date," adding that Novo "believes the FDA is working towards finalizing the review and will let us know ASAP."

If and when it finally wins approval, the Danish drugmaker hopes Saxenda will serve as a springboard into a bright future developing weight-loss treatments, and Novo has already blueprinted a Seattle hub for its future obesity R&D, planning to open a new operation in 2016 and commit about 300 researchers around the globe to the effort.

Scripps researcher and liraglutide investigator Dr. Ken Fujioka

Novo's move comes as the world of medicine increasingly looks at obesity as a chronic disease, much the way it considers diabetes, Chief Science Officer Mads Krogsgaard Thomsen has said. Novo and its $2 billion R&D operation know a thing or two about developing drugs for chronic ailments, and that, coupled with the global rise of obesity, has made expansion a natural next move for the company, Thomsen said.

However, despite Novo's mix of expertise and optimism, the potential market for weight-loss drugs remains murky. Two years ago, both Arena ($ARNA) and Vivus ($VVUS) won FDA nods for new obesity pills with blockbuster hopes, but safety concerns and payer disinterest led to disappointing launches, and both companies have struggled to gain any market traction. In September, Orexigen ($OREX) picked up FDA approval for Contrave, its long-delayed weight-loss treatment, but investors worry that the drug's daunting list of potential side effects will doom it to the same fate.

Novo is certainly aware of all that, and prior failures in the field may in part explain why the drugmaker has gone to such lengths in its 5,000-patient Phase III program for Saxenda.

"Obesity is more than a disease of excess weight," Scripps researcher and liraglutide investigator Dr. Ken Fujioka said in a statement. "We know that people with obesity may experience increased physical and mental health problems, as well as a reduced quality of life. It is encouraging to see data suggesting that the weight loss benefits of liraglutide 3 mg are associated with improved health-related quality of life for people with obesity."

- read the results

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