Competition is heating up in the GLP-1 diabetes market, and Novo Nordisk is doing what it can to line up data behind its long-dominant drug, Victoza. The latest: A study pitting the brand against Sanofi's Lyxumia (lixisenatide), which is lining up for an FDA filing this quarter.
Back in early 2013, the FDA stunned Novo Nordisk and the analysts covering the big diabetes drug player when regulators overrode their outside advisers and decided to require a cardio safety study of its long-acting insulin Tresiba. And now, as Novo steers its way toward a near-term reappraisal at the FDA, the company is ushering in some new data to support the combination of Tresiba and Victoza as analysts once again say an approval is all but certain.
Novo Nordisk has hit a roadblock in its drive to expand the label for Victoza to cover use in Type 1 diabetics. The snag arose when Victoza failed to deliver hypoglycaemic benefit experienced by Type 2 diabetics in people with the other form of the disease in a Phase III trial.
Novo Nordisk keeps on putting up sales growth, with diabetes powerhouse Victoza leading the way. Its pipeline meds are moving along. But the question is whether that pipeline can start paying off soon enough to counteract increasing pricing pressure in the U.S.--and forthcoming biosimilars in Europe.
Former NBA star Dominique Wilkins is not just a spokesman for Novo Nordisk's Victoza. He's also a prize in a Type 2 diabetes sweepstakes the drugmaker is rolling out.
When it comes to which brands spent the most on doctor payments, 2014 crowned a new king--and that's diabetes drug Bydureon.
Novo Nordisk CEO Lars Sorensen told investors today that 2014 had been a more challenging year than most, then rolled off a series of results that showed significant leaps in sales both in the U.S. and worldwide. He then waved off any worries about a price war in the U.S. being a significant issue for the world's largest maker of insulin products this year.
Novo Nordisk has made diabetes-minded investors very happy today. Rather than following Sanofi's discouraging announcement of flat sales expectations in the field next year, the Danish drugmaker said it's expecting growth in the high single digits.
Over the next few days two new contenders for the heavyweight title for weight control drugs face critical regulatory hurdles. After a long and expensive repeat voyage through a late-stage safety study, Orexigen is slated to get the FDA's marketing decision on Contrave by Thursday. And on the same day Novo Nordisk will run through a gamut of questions at an FDA independent panel review of liraglutide 3 mg, with the pharma player betting that it can ultimately get a green light that will open up a new market for its drug that will be worth billions of dollars in added annual sales.
The executive team here at the rapidly expanding headquarters of Novo Nordisk doesn't pull many punches. CEO Lars Rebien S ø rensen is a competitive sort who tends to be blunt, aggressive and forward-thinking; projecting a confident attitude that is reflected by the rest of the execs and right down the line to 40,000 rank-and-file employees around the world.