AstraZeneca yesterday (January 14, 2015) announced that the Phase III PEGASUS-TIMI 54 study a large-scale outcomes trial involving over 21,000 post-myocardial infarction (MI) patients successfully met its primary efficacy end point. The company also reported that preliminary analysis did not reveal any unexpected safety issues. This study represents the first of several large studies that are set to complete over the next two years seeking to expand Brilinta's (ticagrelor) label and drive sales growth.
Patients enrolled in PEGASUS were required to have had an MI within one to three years ago and at least one additional risk factor (age 65 years old, diabetes requiring medication, or documented history of 2nd prior MI [>one year ago]). In the study, patients were randomized to treatment with Brilinta at either 60mg twice daily or 90mg twice daily on a background of low dose aspirin versus placebo plus low dose aspirin. The primary efficacy end point was a composite of cardiovascular death, MI, or stroke. Full results are expected to be revealed at the ACC conference in San Diego in March of this year. Along with the results from the DAPT study, which were presented at the AHA Scientific Sessions in November 2014, this study should spur intense debate regarding the optimal duration of dual antiplatelet therapy following a heart attack.
This positive result from PEGASUS should also be a shot in the arm for Brilinta sales, which have been relatively muted since it first launched in the EU in January 2011. Uptake in the United States has been especially slow, largely as a consequence of the geographical anomalies seen in the Phase III PLATO trial and the ensuing regulatory delays. Brilinta also faced stiff competition from Eli Lilly/Daiichi Sankyo's Effient (prasugrel) and generic clopidogrel. However, while sales of Effient Brilinta's branded competitor in the ACS space appear to have plateaued, Brilinta sales have been rising steadily from $24 million in Q3 2012 to $127 million in Q3 2014 (see graph below), and annual 2014 sales are expected to reach $500 million.
With further results expected in the next two to three years from large Phase III trials investigating Brilinta in patients with peripheral arterial disease (EUCLID), ischemic stroke or transient ischemic attack (SOCRATES), and type 2 diabetes and coronary atherosclerosis (THEMIS), we forecast further sales growth for Brilinta, with annual sales expected to surpass $1 billion by 2017.