Who says the mega-blockbuster is dead? Certainly not Roche research chief Jean-Jacques Garaud, who believes that despite the troubled history of CETP inhibitors, the pharma giant's HDL drug dalcetrapib has the potential to earn upwards of $10 billion a year. And Garaud shrugged off the prospects of Merck's rival HDL drug anacetrapib, which has done even better in the clinic at boosting levels of "good" cholesterol.
"Even though their (anacetrapib's) HDL elevation is higher, that might not be the best marker for potential activity," he told Reuters. "What is important is how much cholesterol we pull from the blood. We think ours is better than any other drug."
But even more importantly than the positive data on HDL levels, Roche's investigators recently were able to reassure observers that in mid-stage studies the drug appeared safe, with no spike in blood pressure.
It's all a far cry from the dark days of 2006, when Pfizer's own high hopes for torcetrapib blew up after investigators tracked a disturbing link to deaths in a late-stage clinical trial. It was one of the costliest trial setbacks in the industry, helping create a reputation for a dysfunctional R&D culture which in turn led to plans to completely revamp the way Pfizer goes about drug discovery and development.
Merck, of course, may not be ready to take a back seat to dalcetrapib. In a Phase II trial their drug was linked to a whopping 138% rise in good cholesterol and a 40% drop in LDL levels. That's a much better result than the 31% boost in HDL levels seen in a mid-stage study for dalcetrapib. Now investigators will put all the numbers to a test in an ambitious slate of late-stage studies which will recruit thousands of patients in order to deliver solid efficacy and safety data to regulators.
It's also important to note that not all analysts are as ultra-bullish as Roche's Garaud on market prospects. Vontobel's Andrew Weiss has estimated potential sales of $5 billion a year. UBS analyst Gbola Amusa projected peak sales at $6.8 billion.
- here's the Reuters story