Crestor goes head to head with Lipitor

Anglo-Swedish drug major AstraZeneca has initiated a new clinical trial, SATURN, which is designed to measure the impact of its cholesterol-lowerer Crestor (rosuvastatin) 40mg and Pfizer's Liptor (atorvastatin) 80mg on the progression of atherosclerosis in high-risk patients.

SATURN will compare the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease. The head-to-head trial of these two blockbusters makes strategic sense for AstraZeneca as Crestor is protected by three key patents expiring in 2016, 2020 and 2021, while Pfizer is due to lose market exclusivity on Lipitor in 2010.

The 104-week, parallel-group, multicenter, double-blind, Phase IIIb intravascular ultrasound imaging study will include 1,300 patients at 170 centers worldwide. The first patient will be enrolled later this month and the study is expected to complete in 2011. SATURN is part of AstraZeneca's extensive GALAXY clinical trials program, designed to address important questions in statin research and to investigate the impact of Crestor on the control of lipids, atherosclerosis and cardiovascular morbidity and mortality. Currently, more than 63,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Program, the firm noted.