AstraZeneca (AZN) recently reported disappointing top-line data on Crestor (rosuvastatin) 40 mg from SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN). The randomized, double-blind, parallel group, multi-center 104-week, phase IIIb study was conducted with approximately 1,300 patients.
The study was conducted to evaluate the effects of treatment with Crestor and Pfizer’s (PFE) Lipitor (atorvastatin) 80 mg on atherosclerotic disease burden as measured by IVUS in patients with coronary artery disease.
Although treatment with Crestor resulted in a greater reduction in plaque buildup in heart arteries compared to Lipitor, the results were not statistically significant. Meanwhile, Crestor achieved its secondary endpoint – change from baseline in total atheroma volume (TAV) within the targeted coronary artery. Detailed results will be presented at the American Heart Association Scientific Sessions in November.
Crestor’s failure to show superiority over Lipitor in the primary endpoint is a setback for AstraZeneca. Lipitor is slated to lose US exclusivity in November 2011 and the onslaught of cheaper generic versions of Lipitor will make it challenging for statins to maintain market share. AstraZeneca was looking to maintain share for Crestor by demonstrating superiority over Lipitor.
While we do not expect current Crestor users to switch to generic versions of Lipitor, we believe AstraZeneca will find it challenging to convince new patients to use Crestor instead of generic Lipitor which will be a cheaper option.
We currently have a Neutral recommendation on AstraZeneca, which carries a Zacks #3 Rank (short-term Hold rating). The company is facing generic competition for several of its products. Crestor, which posted $5.7 billion in sales in 2010, is slated to lose US exclusivity in 2016.
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