Crestor fails head-to-head test against Lipitor
pharmafile | September 2, 2011 | News story | Sales and Marketing | Crestor, Lipitor
AstraZeneca’s cholesterol drug Crestor has failed to show it can stop artery disease better than Pfizer’s Lipitor.
The new study was designed to measure the impact of low dose Crestor (rosuvastatin) 40mg against Pfizer’s Lipitor (atorvastatin) 80mg on the progression of atherosclerosis – a thickening of the artery wall due to the build up of cholesterol in high-risk patients.
Crestor failed to meet its primary endpoint of creating a change from baseline in percent atheroma volume (PAV) in a less than 40mm segment of the targeted coronary artery.
AZ said its drug demonstrated a numerically greater reduction compared to Lipitor, but did not reach statistical significance.
The SATURN study was intended to set Crestor apart from Lipitor, which will face generic competition in the US from November.
As the price of generic forms of Lipitor will be substantially lower than that of branded Crestor, analysts are now questioning whether the drug will be able to keep its place in the market if it cannot be differentiated from the flood of cheap atorvastatins.
Analysts from Matrix say the failure of the study to reach statistical significance calls into question the rationale for use of the 40mg dose of Crestor.
“In our view it potentially muddies the water on the data previously seen in the JUPITER study, which resulted in a label change for Crestor,” they said.
The 2009 JUPITER study showed that Crestor could cut the risk of stroke by nearly half compared to placebo in a sub-group of patients.
This study led to the extension of Crestor’s licence in the US to reduce the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients, putting it on a par with Lipitor’s licence.
Matrix analysts say they will be reviewing their sales estimates for Crestor in light of these new data.
Further SATURN data will be presented at the American Heart Association Scientific Sessions (AHA) on 15 November.
Crestor is licensed in the US as a cholesterol-lowering treatment, for the prevention of heart attack and stroke, and to slow the progression of atherosclerosis.
It is the firm’s biggest selling drug, bringing in $5.7 billion for AZ last year, but this week’s data could damage its market share.
Lipitor is licensed by the FDA for certain patients to reduce cholesterol, reduce the risk of heart attack and stroke, and reduce the risk for revascularisation procedures and angina.
The drug has been the world’s biggest selling drug for a number of years. It brought in $10.7 billion in sales for the firm last year, but has been sliding steadily from its peak annual sales of around $14 billion.
Ben Adams
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