Novartis ($NVS) has hit a big obstacle in its push to expand use of the bone drug Zometa. A new study showed that the drug didn't keep breast cancer at bay or prolong patients' lives, almost exactly the opposite of the results observers--and the company--were expecting. An earlier, smaller study had indicated that Zometa helped prevent recurrence, and the company was so confident of this new data that it had already asked FDA for a breast cancer indication.
Now, the Swiss drugmaker will pull its applications for the new use--to prevent breast cancer relapse--in Europe and the U.S. The company is deciding whether to pursue a new trial to support a new application for approval. That's in part because the study did show a survival benefit in a subset of patients, namely women who were five years post-menopause.
The new Zometa indication was part of Novartis' patent-cliff strategy: The drug loses protection in 2013, but the new use could have won three additional years of exclusivity. And some analysts were touting the breast-cancer indication as a $1 billion sales booster by 2015. "This will be a surprise to most people," the lead investigator, Dr. Robert Coleman, told Reuters. "I think most people expected this to be a positive trial, but it isn't."