AstraZeneca (AZN) recently announced full results from its phase IIIb SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN), which evaluated the efficacy of Crestor vs. Pfizer’s (PFE) Lipitor (atorvastatin) on atherosclerotic disease burden as measured by IVUS in patients with coronary artery disease. Negative top-line results from the trial were declared earlier on September 2, 2011.
Crestor showed a statistically significant change in the primary efficacy measure, percent atheroma volume (PAV), from the baseline following 2 years of treatment. Although a numerically higher reduction in PAV was achieved by Crestor compared to Lipitor, the difference was not statistically significant.
Meanwhile, Crestor did show a statistically significant reduction in normalized total atheroma volume (TAV), the secondary efficacy measure, as compared to Lipitor. It was found that Crestor significantly lowered LDL-C or bad cholesterol levels, increased HDL-C or good cholesterol levels, helped patients achieve LDL-C of less than the 70 mg/dl target and lowered total cholesterol levels as compared to Lipitor. Safety and tolerability of both Crestor and Lipitor were similar to that observed in previous studies.
Lipitor is slated to lose US exclusivity on November 30, 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, new patients may opt for generic Lipitor which will be a cheaper option.
Our Recommendation
We currently have a Neutral recommendation on AstraZeneca. The stock carries a Zacks #3 Rank (Hold rating) in the short run. Even though we are encouraged by the strong cardiovascular franchise at AstraZeneca and the company’s focus on the high-potential emerging markets, we remain concerned about the generic competition faced by AstraZeneca’s key products.
The company is looking to lessen the impact of genericization by reducing its cost structure. Meanwhile, the weak late-stage pipeline at AstraZeneca also bothers us.
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