AstraZeneca (AZN) recently said that results from a phase III head-to-head trial showed that its Brilinta (ticagrelor) achieved greater efficacy in the primary endpoint, reduction of cardiovascular events, compared to Sanofi-Aventis/Bristol-Myers’ (SNY/BMY) Plavix (clopidogrel).
Brilinta significantly reduced the mortality rate from cardiovascular events, myocardial infarctions and strokes without increasing major bleeding, which is a side-effect of Plavix. However, the frequently reported side-effects of Brilinta included slower heart rhythms and dyspnoea.
Brilinta is an investigational oral anti-platelet treatment being developed for acute coronary syndrome (ACS). Results from the 18,624 patient PLATO (A Study of Platelet Inhibition and Patient Outcomes) trial were presented at the European Society of Cardiology congress and published in the New England Journal of Medicine (NEJM).
The data on Brilinta look compelling and could help the product gain market share from Plavix once launched. Sanofi-Aventis recorded 2.6 billion Euros from Plavix sales last year, which implies huge potential for Brilinta upon approval. Management is touting the potential benefits of Brilinta relative to Plavix and Eli Lilly’s (LLY) Effient, including its rapid onset and offset and reliable efficacy.
With Plavix scheduled to lose patent protection in the U.S. in 2011, AstraZeneca could benefit if it succeeds in bringing Brilinta to market before Plavix goes generic. The timely approval and launch of Brilinta could help the drug maintain market share and reduce patient switching to generic Plavix. AstraZeneca is looking to file for approval in both the U.S. and the EU in the fourth quarter.
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