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.
Last year's FDA delay on Novo Nordisk's Tresiba was a major setback for the long-acting insulin that analysts said would severely dampen its earnings potential. But in the ever-changing pharma landscape, a new development has Novo CEO Lars Rebien Sørensen thinking the company may still get Tresiba to the U.S. market ahead of any significant competition.
Last year's stinging FDA rejection for Novo Nordisk's Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.
Three's a charm for Novo Nordisk and its recombinant Factor XIII compound for a rare bleeding disorder. After receiving a complete response letter in 2012 and then again this August, the drugmaker has gotten FDA approval for Tretten. It is an end-of-the year win in what has been a sometimes difficult year for the Denmark-based company.