Novo Nordisk Trial Shows Victoza Helps Patients Lose Weight

Novo Nordisk A/S, the Danish maker of the Victoza diabetes treatment, said the medicine was successful in helping patients lose weight when used to fight obesity in a late-stage clinical trial.

People suffering from type 2 diabetes, the most common form of the disease, lost 6 percent of their weight when treated with a three-milligram dose of Victoza, a diabetes drug already on the market that isn’t yet approved for weight management, Novo Nordisk said in an e-mailed statement today.

The results show it’s “possible to achieve both clinically significant weight loss and excellent glucose level control with a single treatment,” Novo Chief Scientific Officer Mads Krogsgaard Thomsen said in the statement.

Victoza, also known as liraglutide, is Novo’s biggest growth engine. Sales of the medicine, which mimics a hormone called GLP-1 to stimulate natural insulin production, jumped 58 percent in 2012. Diabetes is often associated with weigh gain, a condition which makes it harder for the body to maintain proper blood-sugar levels. Weight gain is also common in people taking insulin, another anti-diabetic.

The 56-week trial was conducted on 846 overweight or obese diabetics taking either a three-milligram dose, a 1.8-milligram dose, or a placebo, Novo said. Patients taking the 1.8-milligram dose lost 5 percent of weight, and those on placebo lost 2 percent, the company said. The trial participants also achieved blood-glucose level control, it said.

Regulatory Uncertainty

Novo, based in Bagsvaerd, outside of Copenhagen, expects to complete the two remaining late-stage trials for Victoza used as an obesity medicine by mid-2013, the company said today.

“We see limited commercial upside from liraglutide in obesity, as well as significant regulatory uncertainty,” Richard Vosser, an analyst at JPMorgan Chase & Co., wrote in a note to clients today. He cut the stock’s recommendation to underweight from neutral.

Novo fell 3.9 percent, the most since Feb. 11, to 960 kroner in Copenhagen.

Victoza is among the diabetes treatments being scrutinized by U.S. regulators for a potential link to pancreatic cancer, the Food and Drug Administration said in a March 14 statement.

The FDA is reviewing unpublished findings by a group of academic researchers that suggest pre-cancerous cellular changes may be associated with type 2 diabetes drugs called incretin mimetics, including Victoza, the agency said. The findings suggest the class of medicines may be linked to the risk of developing an inflammation of the pancreas tied to cancer and kidney failure that was previously reported in some of the medicines.

The agency said the same day it hasn’t reached any new conclusions about the safety risks associated with the drugs and hasn’t determined whether they may cause or contribute to pancreatic cancer.

Novo “is not aware of any new data suggesting a causal link between our product and the adverse events discussed in the statement from the FDA,” Katrine Rud von Sperling, a Novo spokeswoman, said in e-mailed comments on March 14.

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