Novo Nordisk’s Thomsen Says IDegLira Data ‘Unprecedented’

Novo Nordisk A/S’s combination of a new insulin with its established Victoza therapy lowered blood-sugar to unprecedented levels and should be an important diabetes treatment once approved, Chief Science Officer Mads Krogsgaard Thomsen said.

Late-stage trial results presented at the American Diabetes Association in San Francisco showed that IDegLira, a once-daily injection combining Tresiba, Novo Nordisk’s new insulin, and Victoza lowered blood sugar more than each medicine taken on its own, Novo said in an e-mail today.

“Whatever way you cut the data on IDegLira, it’s simply unprecedented in terms of efficacy,” Thomsen said by telephone. “We’ve looked at the data across spectrums, how long the duration of the disease is, and how overweight people are, and IDeglira simply just works in all these categories.”

The prospects for Tresiba and its combination with Victoza are critical for Bagsvaerd, Denmark-based Novo Nordisk, the world’s biggest insulin maker. Sales of Victoza, its biggest growth engine, are rising at a slower pace than in the past and the company suffered a setback last year when U.S. regulators rejected Tresiba, now sold in other countries, including Denmark, the U.K., Switzerland, Sweden, Mexico and Japan.

Results from the IDegLira extension trial show that at 52 weeks the combination medicine reduced HbA1c, a measure of blood-sugar concentration, by 1.8 percent from baseline, versus 1.4 percent for Tresiba and 1.2 percent for Victoza, Novo Nordisk said in the statement. The average HbA1c at the end of the trial was 6.4 percent for IDegLira, 6.9 percent for Tresiba and 7.1 percent for Victoza.

European Decision

Novo Nordisk has already filed for approval of IDegLira in the European Union. The European Medicines Agency’s Committee for Medicinal Products for Human Use is set to announce its opinion on the combination medicine “over the next couple of months,” Thomsen said during the interview. The European Commission, the EU’s executive arm, usually follows the panel’s recommendation.

Novo Nordisk plans to start introducing IDegLira in some European countries, including the U.K., either later this year or in early 2015, Thomsen said. Novo Nordisk won’t apply a premium to the price of the new medicine, Thomsen said.

“What we’ll be paying here is just the sum of the parts,” he said. “There’s not going to be a premium in spite of the development costs.”

Diabetes affects 382 million people worldwide, spurred by poor diet, a sedentary lifestyle, and obesity, according to the International Diabetes Federation. Diabetics lack the insulin their body needs to convert blood sugar into energy. To keep the disease under control, they must closely track their sugar intake and often need multiple insulin shots a day to survive.

Revenue from Victoza, a diabetes medicine that mimics a hormone called GLP-1 and stimulates natural insulin production, climbed to 2.92 billion kroner ($530 million), missing analysts estimates, in the first quarter.

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