Mixed results for AZ’s troubled Brilinta
pharmafile | September 3, 2014 | News story | Sales and Marketing | AstraZeneca, Brilinta, EMA, PCI, atlantic, heart, stent
The latest trial for AstraZeneca’s heart drug Brilinta (ticagrelor) has failed to meet expected results but suggests more flexible applications for the drug are possible.
The results of the Phase IV ATLANTIC trial showed no significant difference between pre-hospital and in-hospital administration in terms of pre-PCI procedural effectiveness, but did indicate that giving patients Brilinta before they reach the hospital carries no increased risk of bleeding.
The data also show a reduction in the risk of post-PCI stent thrombosis, though there were no other statistically significant effects on patient outcomes.
Marc Ditmarsch, AZ’s global development lead for Brilinta – marketed as Brilique in Europe – calls the stent thrombosis results ‘encouraging’ and adds that they ‘warrant further investigation’.
These results mean AZ’s troubled drug could be administered to a wider range of patients in the future, but this may not be enough to turn its fortunes around.
Brilinta has had several setbacks throughout its history, and this latest study is one of several post-marketing trials, including Plato and Pegasus, which aim to find new applications for the drug in order to expand its patient base and potentially increase sales.
The FDA delayed its initial 2010 review of Brilinta twice, and in 2013 the EMA demanded more information on the drug while the Plato trial was under investigation by the US Department of Justice.
Brilinta has also had a poor sales trajectory. Despite initially being forecast as a blockbuster with sales of up to $2.5 billion, it brought in a disappointing $117 million in the second quarter and is forecast to bring in just $500m overall this year.
AstraZeneca, meanwhile, has seen sweeping R&D job cuts in recent years as well as several costly late-stage failures that resulted in the resignation of its previous chief executive, David Brennan.
According to analysts at EP Vantage, the Atlantic trial only confirms that a practice many cardiologists are already following is safe, and that it therefore may have only an ‘incremental’ effect on sales to help the firm.
“It does, however, set the table for a much bigger milestone, the results of the Pegasus trial,” the analysts say.
The Pegasus trial compares Brilinta and aspirin with aspirin alone to study its long-term efficacy and safety in heart attack patients. Its results are due by the end of the year.
George Underwood
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