If AstraZeneca ($AZN) was hoping for unqualified jubilance at its latest Brilinta trial results, they are no doubt disappointed. Much-anticipated data on the clot-fighting drug, unveiled over the weekend at the American College of Cardiology meeting, showed that Brilinta did stave off serious cardiovascular problems, when used long term alongside aspirin. But the numbers were small enough--and the bleeding risks high enough--to put a damper on new sales hopes.
In the PEGASUS trial, Brilinta cut the risk of cardiovascular death, stroke and heart attack by 15% to 16%, but the absolute difference was pretty small. About 7.8% of patients in the Brilinta arm suffered one of those complications, compared with 9% of placebo patients.
Meanwhile, the rate of major bleeding was about 2.5% in Brilinta patients, compared with 1% of placebo patients.
AstraZeneca has bet a lot of R&D spending--and placed a lot of hope--on the prospect that Brilinta could become a big earner if only doctors and patients knew how well it could work. PEGASUS is part of a suite of outcomes trials aimed at that very proposition. The study looked at using Brilinta longer than current guidelines recommend, to see whether extending therapy with Brilinta plus aspirin--so-called dual antiplatelet therapy, or DAPT--could prevent more heart attacks, strokes, and CV-related death.
The idea is that, if Brilinta proved helpful in the long term, then patients could take the drug for up to three years after a heart attack, rather than the one year currently advised. That, of course, could triple the amount of sales per patient. And, even better, might induce more patients onto the combo to begin with.
The New England Journal of Medicine published the PEGASUS study, with an editorial alongside interpreting the results. And to the editorial writer, the prevention numbers were definitely tempered by the bleeding risks. On balance, it's "close to an even proposition," the editorial stated.
"[T]hese data prompt speculation as to whether dual platelet inhibition with high-potency agents is approaching the point of diminishing returns," the editorial stated.
Bernstein analyst Tim Anderson wasn't blown away by the numbers. "It seems unlikely to us that based on these results, there will be substantial changes to consensus estimates" for Brilinta sales, Anderson wrote in a Monday note to investors. Bernstein expects about $1.3 billion from Brilinta in 2020, up from $475 million last year.
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| AstraZeneca CEO Pascal Soriot |
AstraZeneca, by contrast, has pegged Brilinta with more than $3 billion in peak sales. The drug is one of the half-dozen growth prospects AstraZeneca is counting on to fuel sales over the next decade or so--which means it's one major chapter in the growth story CEO Pascal Soriot has been telling since he rejected Pfizer's ($PFE) hostile bid last May. At the time, Soriot projected $45 billion in sales by 2023.
Brilinta has made some big strides since Soriot declared it a diamond in the rough back in 2012. Last year's $476 million was a 70% increase over 2013. And those 2014 numbers came despite a big disadvantage in the U.S. market, which Soriot rightly says is paramount to Brilinta's long-term success. For most of the year, AZ had halted marketing in the U.S. while the Department of Justice investigated allegedly tainted data in another Brilinta trial, PLATO. The feds ended that probe last August, saying they planned to take no action--and unfettering AZ's Brilinta marketing plans.
Now, the PEGASUS data is going to regulators in the U.S. and Europe. AstraZeneca said Monday that it has submitted the results, aiming to modify Brilinta's label for new-and-broader use. If the FDA and EMA bless the data, then the company will have powerful backing for their case to extend Brilinta therapy. And while there's obvious skepticism about the idea, some analysts see a positive case.
UBS figures sales could beat consensus estimates, citing ACC talk about the study. "Some ACC panelists argued that Pegasus showed that patients with atherosclerosis risk should remain on dual anti-platelet therapy ... probably indefinitely," UBS analysts wrote in a Monday investor note, "whereas other panelists were more cautious, pointing to the bleeding risk." On balance? The study is "unlikely to drive broad uptake" but could still be "a key tool" in AstraZeneca's marketing toolbox.
- see the release from AstraZeneca
- get the study from the NEJM
- read the NEJM editorial
Special Reports: Top 10 pharma companies by 2013 revenue - AstraZeneca | Top 10 Drug Launch Disasters - Brilinta