Amgen last night released top-line results from a Phase III head to head study pitting its most important future drug, denosumab, against Novartis’ Zometa in breast cancer-linked bone complications.
The results look good—better than most expected. Denosumab appears to be not simply non-inferior to Zometa (the primary endpoint of the study) but superior to Novartis’ incumbent drug—itself pretty potent--in terms of delaying the time to first and subsequent skeletal-related events.
The probability of superiority in this second trial, plus another in prostate cancer due to report in 2010 has now risen, according to analysts at Leerink Swann. And when it comes to potential oncology indications, Amgen’s not leaving any stone un-turned: it recruited 11,000 patients for its d-mab cancer trials, out of a total of 19,000.
All the same, since Zometa goes generic in 2013, and there are already some filings, Amgen will have to move fast to translate this apparently starry trial data into equally sparkling sales growth. Payor pressure means even a ‘superior’ drug may struggle if generic IV bisphosphonates get cheap enough. (Leerink Swann expects Amgen to price d-mab higher than the $12,000-p/a Zometa.)