October 30, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Danish drugmaker Novo Nordisk has walked back its optimistic launching date for diabetes drug Tresiba, saying that instead of 2016 it will now roll out the drug in 2017.
Novo, the world’s largest insulin maker, had initially applied for approval of Tresiba in 2013, which the U.S. Food and Drug Administration rejected, directing the company to conduct further studies on the drug’s safety, especially with regard to heart risk. At that time, the company believed this would delay a launch until 2017.
The picture looked different in August 2014, when after the disclosure of the company’s second quarter results, CEO Lars Rebien Sorensen spoke to journalists about Tresiba. Sorensen said the study requested by the FDA, called DEVOTE, should be complete by the end of 2014 or the beginning of 2015. Sorensen was quoted as saying, “If we calculate the best possible scenario then we could see an approval by the end of the year, meaning a launch into the beginning of 2016.”
Novo Nordisk hosted a conference call on Thursday to discuss its quarterly report and again addressed Tresiba. The company said it had not decided whether to submit an interim analysis or the complete study to the FDA, the choice of which would dictate the launch schedule.
“Our confidence in the ‘DEVOTE’ and the interim analysis is completely unabated and unchanged. It is just a change in the strategy,” Chief Science Officer Mads Krogsgaard Thomsen was quoted as saying by Reuters.
In the wake of the conference call, the investment bank Jefferies released a note saying, “The language around the interim analysis and potential filing of the DEVOTE study for Tresiba appears to be somewhat more cautious than previously issued, with the company warning that the interim analysis carries a higher level of uncertainty than the final results and that it may not support resubmission despite a positive final result.”
Despite the news, share prices of Novo rose 4.2 percent after the release of its third quarter results. Perhaps the stock price did not take a hit because Novo also forecast that its operating profits would increase by 10 percent in 2015, according to Bloomberg.
