Thursday, June 12, 2008
COPENHAGEN, June 11 (Reuters) - Denmark's Novo Nordisk (NOVOb.CO: Quote, Profile, Research) said on Wednesday it stopped a Phase III trial with its NovoSeven drug for treatment of bleeding in severe trauma, but added the decision was not due to safety concerns.
It said the study population had a mortality rate of 10 percent compared to more than 25 percent in the preceding Phase II trial. The study, it said, was unlikely to determine whether NovoSeven would be successful in this treatment area.
"Of course it's not positive but I had not factored in an additional (indication) for NovoSeven," said Sydbank analyst Rune Dahl. "The way to view NovoSeven currently is as (a drug with) stable sales in its existing area, and nothing more." NovoSeven is a haemophilia drug with total sales of 5.9 billion Danish crowns ($1.23 billion) last year.
By 1302 GMT, Novo shares were down 1 percent at 310 crowns on the Copenhagen exchange after briefly falling as much as 4 percent.
A Novo Nordisk spokesman said that the company had not yet decided whether to design a new Phase III study with NovoSeven for bleeding in severe trauma.
In February 2007, Novo Nordisk halted regulatory filing for the drug for bleeding in the brain after initial results from a Phase III clinical trial showed NovoSeven reduces bleeding in the brain but does not improve long-term clinical outcomes.