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www.fdanews.com/articles/91910-astrazeneca-atherogenics-heart-drug-missed-study-goal

ASTRAZENECA, ATHEROGENICS' HEART DRUG MISSED STUDY GOAL

March 19, 2007

AstraZeneca announced that its collaboration partner, AtheroGenics, has revealed first results from the ARISE Phase III clinical trial, which studied AGI-1067, an investigational anti-atherosclerotic agent with antioxidant and anti-inflammatory effects, in patients with coronary artery disease.

The ARISE trial did not meet its primary endpoint of a statistically significant relative risk reduction in a composite cardiovascular endpoint of cardiovascular death, resuscitated cardiac arrest, nonfatal myocardial infarction, nonfatal stroke, use of coronary revascularisation and angina pectoris with objective evidence of ischemia.

AstraZeneca and AtheroGenics will now work together to analyze the full data set for AGI-1067, including these first results, the companies said. After completion of the final analysis, under the terms of the license and collaboration agreement, AstraZeneca has 45 days to decide whether to continue with the collaboration. AtheroGenics said it would continue development of the drug.

The study was a Phase III, multicenter, double-blind, parallel-group, placebo-controlled trial that took place at approximately 260 study sites in the U.S., Canada, South Africa and the UK. The trial enrolled more than 6,000 patients.