Does Brilinta's Brilliance Beggar Belief?

The European Medicines Agency is demanding more information from AstraZeneca on its troubled heart pill Brilinta. This rounds off a tough few weeks for the firm as it comes after the US Department of Justice (DOJ) took the unusual decision to investigate the product in late October. Neither AZ nor the DOJ have disclosed the exact nature of the investigation, but analysts believe it relates to various aspects of the study that have been criticised by external researchers. This includes comments from James DiNicolantonio of Ithaca New York, and Ales Tomek of Charles University in Prague, who said in a recent paper that patients in the PLATO trial monitored by AstraZeneca were reported as benefiting more from taking Brilinta (ticagrelor) - than those monitored by an independent clinical research organisation. Bernstein analyst Tim Anderson said in a research note this week that there could be ‘material downside’ for AstraZeneca if the DOJ investigation revealed serious flaws in the study. AstraZeneca’s chief executive Pascal Soriot is not panicking yet, and said last week he was ‘very confident’ in the findings of the pivotal study, although this new probe by the EMA will not instil much confidence. Brilinta was originally touted as a blockbuster with peak sales expected to reach around $2 billion, but growth has been slow with sales in the third quarter reaching just $75 million, up marginally from the $65 million in the second quarter. This has been disappoint...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs