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Generic atorvastatin may be better than Crestor Posted 30/09/2011

AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin) failed to show a statistically significant benefit over Pfizer’s Lipitor (atorvastatin), according to results of a phase IIIb trial. The results could prove to be good news for generics manufacturers, boosting sales of generic atorvastatin, soon to compete with Crestor.

The randomised, double-blind, parallel group, multi-centre phase IIIb study, dubbed SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN), was carried out over 104 weeks in approximately 1,300 patients. SATURN was designed to measure the impact of Crestor (rosuvastatin) 40 mg and atorvastatin 80 mg on the progression of atherosclerosis in high-risk patients.

Crestor failed to show that it was statistically better at clearing clogged arteries compared to Lipitor. It did, however, show a significant improvement over Lipitor in a secondary endpoint of the trial, which used ultrasound to measure the condition of coronary arteries.

This was not the news AstraZeneca had been hoping for, with cheaper generic atorvastatin drugs set to hit the market at the end of November 2011. These results would suggest that the majority of patients would have no better results by taking brand-name Crestor compared to generic atorvastatin, which could severely impact Crestor’s sales upon patent expiry of Lipitor.

Crestor is AstraZeneca’s biggest-selling drug, with 2010 sales of US$5.7 billion (GBP 3.5 billion) and clear superiority would have helped prevent market erosion by generic atorvastatin drugs.

In the US, Lipitor’s patent expires on 30 November 2011, at which stage both Ranbaxy Laboratories and Watson are expected to launch generic versions [1].

The stakes are high. Lipitor had sales of US$10.8 billion in 2010 alone and has been the world’s best-selling drug for the last 10 years, generating 27% of Pfizer’s income [2]. If generic versions of atorvastatin can also impact Crestor sales, then there is a huge market and huge savings to be made.

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1. GaBI Online - Generics and Biosimilars Initiative. Sanofi France to make generic atorvastatin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 30]. Available from: www.gabionline.net/Generics/News/Sanofi-France-to-make-generic-atorvastatin

2. GaBI Online - Generics and Biosimilars Initiative. Mylan tries to block Ranbaxy’s Lipitor exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 13]. Available from: www.gabionline.net/Generics/News/Mylan-tries-to-block-Ranbaxy-s-Lipitor-exclusivity

Source: AstraZeneca, FDAnews, Reuters

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