Head-to-head boost for Brilinta over Plavix

AstraZeneca has released details of its brand Brilinta's performance in head-to-head trials with Plavix, the world's second biggest-selling drug.

Earlier this year in May, the manufacturer's shares rose on news that it had outperformed Sanofi-Aventis/Bristol-Myers Squibb's antiplatelet blockbuster.

That was followed this week by results of the PLATO trial, which were released at last month's annual congress of the European Society of Cardiology in Barcelona and published in the New England Journal of Medicine.

The study showed Brilinta (ticagrelor) reduced cardiovascular death and heart attacks when compared to Plavix (clopidogrel) in acute coronary syndromes (ACS) patients.

This means the drug could be "a valuable new option for a broad range of ACS patients", said Anders Ekblom, AstraZeneca executive vice president development.

The primary endpoint was reduction of cardiovascular events (that is, CV death, myocardial infarction or stroke) over Plavix and, crucially, this was achieved without an increase in major bleeding.

"The goal of new antiplatelet therapies is to improve the efficacy for patients without increasing the associated risks of treatment," said Professor Lars Wallentin, co-chair of the PLATO study executive committee.

There were reductions in both CV death and heart attacks, with no difference in stroke.

Brilinta is the first investigational antiplatelet to have achieved a reduction in CV death versus Plavix in ACS patients.

The reduction in risk of cardiovascular events occurred early and this benefit increased over time compared to Plavix, AstraZeneca said.

Despite the PLATO results Plavix, which last year made sales of $8.6 billion, is unlikely to be overhauled.

But Brilinta's performance can give AstraZeneca a foothold in the lucrative antiplatelet market.

Analysts have suggested its sales could peak at $3 billion and it will be filed in Europe and the US before the end of the year.

Both drugs are up against Eli Lilly and Daiichi Sankyo's Effient (prasugrel) in the ACS market.

Over 18,000 patients were enrolled in the PLATO study, including patients who underwent invasive procedures and those who were managed with medication only.

When patient groups were broken down into subgroups of gender, weight and history of stroke, Brilinta showed no increase in the incidence of major bleeding versus Plavix. But when minor bleeding was added, it did show an increase.