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ASTRAZENECA, SHIONOGI - Top Line Results from SATURN confirms Lipitor Generic Entry Is Detrimental for Crestor
MP Advisors, Sep 2011
AstraZeneca announced mixed top line results from most awaited SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin versus Lipitor) study, comparing Crestor 40mg to Lipitor 80mg, on the progression of atherosclerosis in high risk patients. On the primary efficacy endpoint – Crestor failed to show statistically significant reduction in PAV (percentage atheroma volume) in > 40mm segment of the targeted coronary artery as measured by IVUS, although it was better numerically. On secondary efficacy endpoint Crestor demonstrated a statistical significant reduction from baseline in total atheroma volume within the targeted coronary artery compared with Lipitor. Although atheroma volume by IVUS is not a validated surrogate marker for clinical outcome, the results do put a question mark on whether additional potency in LDL reduction/HDL rising will translate into better outcome. We foresee upto 20% decline in Crestor sales post Lipitor patent expiry. A successful outcome from SATURN, would have given AZN marketing ammunition to grow post Lipitor patent expiry, but this event turns the table against Crestor. We now expect Crestor will be used only in patients not adequately controlled to their recommended goal on Atorvastatin.
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