After a surprise FDA rejection sent it back to the drawing board in 2013, Novo Nordisk is finally ready to resubmit Tresiba, a long-acting insulin with blockbuster potential.
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 is sounding a more cautious tone on Tresiba, its once-rejected new insulin. After hinting at an accelerated trip back to the FDA for the long-acting diabetes treatment, the Danish drugmaker now says it could be another few years before the injection is ready for another shot at approval.
Novo Nordisk is hustling to get work done so that it can resubmit its blockbuster hopeful Tresiba to the FDA next year with an eye on getting into the market by 2016, three years after the FDA squelched its plans with its initial denial. In the meantime, Novo is finding new ways to combo Tresiba up and sell it in Europe where it is approved.
Novo Nordisk bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.
Danish financial regulators took a dim view of Novo Nordisk's decision to spend the weekend pondering the FDA's February 2013 snub to Tresiba before spreading the news of the agency's complete response letter and the major delay that would be triggered by its demand for a new study. And today Novo said it had decided to accept a $90,000 fine to close the books on the incident, not the least bit chastened at the slap on the hand.
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.
Diabetes market giant Novo Nordisk surprised investors today with second-quarter earnings that came in above expectations, and the news that it plans to report critical clinical trial data on its long-acting insulin treatment, Tresiba, in mid-2015, setting the drug up for a 2016 approval by the FDA.
Last year's surprising FDA rejection blew a hole in Novo Nordisk's plans to capitalize on a new long-acting insulin, but the Danish drugmaker said its follow-on study is coming through ahead of schedule, clearing the way for a 2016 launch.
Novo Nordisk has decided to play ball in Germany. The Danish drugmaker now plans to launch its brand-new diabetes drug Tresiba in that country, despite a notorious pricing policy that Novo feared would interfere with its success.