Apparently, not every study can go Novo Nordisk's
The drug in question is Novo Nordisk's NovoSeven, approved as a treatment for bleeding problems related to hemophilia. It's one of Novo's most important compounds, with sales of approximately $290 million in the first quarter. Other hemophilia treatments, like Wyeth's
In an effort to expand NovoSeven's use, the company had been testing its performance in several other indications where bleeding is a problem, such as severe trauma and intracerebral haemorrhage (ICH). Last year, Novo announced that the compound had failed to improve patients' survival in a phase 3 ICH study. On Wednesday, the company went 0 for 2, declaring an early end for its phase 3 severe trauma study, because the trial wouldn't be able to show that the compound was effective at stopping bleeding in badly injured patients.
Taking Novo's press release at face value, there's at least one silver lining: The study didn't fail because of safety-related issues. If adverse events had popped up, Novo would not only be stymied in its efforts to expand NovoSeven's applications, but might also lose a chunk of its current market share as nervous patients chose different treatments.
NovoSeven's failure in severe trauma will surely cut into some off-label usage of the compound worldwide. The study's results are particularly disappointing, because good news could have provided an immediate boost to Novo Nordisk's top line. Nonetheless, Novo has still enjoyed a relatively good string of news lately, having announced last week that a late-stage diabetes drug in its pipeline had bested Eli Lilly's
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