In the fall of 2003, Karen Gotting-Smith thought her new job as project leader at AstraZeneca in charge of launching the cholesterol-lowering drug Crestor (rosuvastatin) in the US and global market would be relatively straightforward. After all, Crestor had already been approved in Europe the year before, and just that summer got a nod from a public Food and Drug Administration advisory committee.
But launching Crestor turned out to be much more complicated than Gotting-Smith anticipated. In 2001, Bayer Pharmaceutical withdrew its statin Baycol from the market after finding it could induce a fatal release of muscle cells into the bloodstream, thereby causing public sentiment toward statins - which inhibit the cholesterol-forming enzyme HMG-CoA reductase - to become tainted. On top of it all, Crestor had the disadvantage of being the sixth statin to enter the market.
Gotting-Smith and her team had to come up with innovative ideas to counter ...
