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Brilinta outperforms Plavix in trial

Top-line results for AstraZeneca's pipeline drug Brilinta have shown that it outperforms in a head-to-head with competing medication, Plavix

Top-line results for AstraZeneca's pipeline drug Brilinta have shown that it outperforms in a head-to-head with competing medication, Plavix from Bristol-Myers Squibb and sanofi-aventis.

Both products are used in the prevention of cardiovascular events in patients with acute coronary syndromes (ACS) and the results raise AstraZeneca's hopes for a pipeline product that analysts see as a potential multibillion-dollar-a-year seller. Analysts at the French brokerage Natixis estimate potential peak sales for Brilinta to treat ACS at $600m.

The new medicine is seen as a chance for AstraZeneca to prove its ability to get major new drugs to market following a drought of new product launches in recent years.

The PLATO (A Study of Platelet Inhibition and Patient Outcomes) study involved 18,624 ACS patients in 43 countries and was led by Professor Lars Wallentin at Sweden's Uppsala Clinical Research Center and co-chaired by Professor Robert Harrington, Duke Clinical Research Institute, in the US. The head-to-head study of the two drugs is one of the largest comparative trials ever undertaken before approval.

AstraZeneca said it plans to submit Brilinta for regulatory approval in the fourth quarter. The company intends to submit the data to a peer-reviewed medical journal and present at the European Society of Cardiology annual meeting in August.

The trial also demonstrated that the overall safety profile for Brilinta was in line with the safety data observed in the phase II studies.

About one in three ACS patients die, have a recurrent heart attack (also known as myocardial infarction), or are readmitted to hospital within six months of their first cardiovascular event occurrence.

11th May 2009

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