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Novo Nordisk reports progress on US permit

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Novo Nordisk reports progress on US permit
Novo Nordisk insulin researchers Ib Jonassen and Svend Havelund. Photo: Novo Nordisk
13:27 CEST+02:00
The company on Thursday reported an four percent increase in the second quarter and said that its insulin drug Tresiba could hit the US market ahead of its competitors.
Danish pharmaceutical giant Novo Nordisk, the world's top insulin maker, reported rising quarterly profits on Thursday and said studies required to release long-acting insulin drug Tresiba in the US would be completed sooner than previously thought.
 
Net profit in the second quarter rose by four percent to 6.99 billion kroner (938 million euros, $1.25 billion) as revenue grew one percent to 21.63 billion kroner.
 
Stated in local currencies, revenue was 7.0-percent higher than a year ago, driven by sales of Victoza, which controls blood sugar levels by mimicking an intestinal hormone called GLP-1, and modern insulins like the long-acting Levemir.
 
The US Food and Drug Administration (FDA) said in February last year that approval for the group's once-daily insulin drug Tresiba could not be granted until the company provided more cardiovascular data.
 
"Novo Nordisk now expects to have data to support the pre-specified interim analysis of major adverse cardiovascular events around the turn of the year. Previously, this was expected mid-2015," the company said.
 
Last year, Novo Nordisk lost two contracts with US health benefit manager Express Scripts, which negotiates drug prices for millions of insured Americans.
 
Sydbank analyst Søren Løntoft Hansen told Danish news agency Ritzau that revenue was slightly below expectations but that earnings were above his estimates due to lower costs for distribution and research and development.
 
The new completion date for the US Tresiba trial meant Novo Nordisk would enter "this hugely important market" earlier than thought, and "probably also earlier than some of the competitors," he said.
 
The Bagsværd-based group reiterated its full-year guidance, which it lowered in May to between seven and 10 percent sales growth in local currencies.
 
Novo Nordisk has almost half the global insulin market, which has grown rapidly in recent years following a rise in the number of people suffering from diabetes, estimated by the World Health Organization to stand at nearly 350 million.
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