When Pascal Soriot took the reins at AstraZeneca in 2013, he plucked out Brilinta as a growth product. The clot-fighter had struggled since its launch in 2011, but Soriot figured AstraZeneca could turn that around by broadening its market and investing in marketing.
And when Pfizer came calling with a buyout offer in 2014, Soriot doubled down on that prediction, setting out a $3.5 billion goal for sales by 2023.
That project has fallen short again.
Brilinta just failed its second trial in less than 6 months, dashing hopes for a new indication in peripheral artery disease (PAD). In a trial in stroke patients released earlier this year, SOCRATES, the drug proved no better than aspirin at preventing new strokes, heart attack or death.
Now, AstraZeneca says it’s no longer hoping for $3.5 billion in sales from the drug. “We don’t believe the goal of $3.5 billion is attainable,” AstraZeneca’s Brilinta chief, Ludovic Helfgott, told Reuters. “I think it would be unrealistic to believe that.”
Deutsche Bank analysts recently estimated that unapproved indications could make up $750 million of Brilinta’s 2022 revenue, which analysts these days peg at $2.1 billion.
The disappointing PAD data came from the 13,885-patient EUCLID trial, which pitted Brilinta against clopidogrel, the current standard treatment and a now-generic drug sold under the Plavix brand by Sanofi and Bristol-Myers Squibb. Brilinta failed to best clopidogrel at preventing blood-clot complications in PAD patients. The primary endpoint was a composite of heart attack, stroke and cardiovascular death.
It’s a blow to AZ, particularly after Brilinta had begun to gather speed. Stepped-up marketing and one new indication helped boost sales by 48% for the first half of this year. For the first quarter alone, new-to-brand scripts rose by 12%.
That new indication–for longer-term use in patients who’ve had a heart attack or other serious coronary problems–won an FDA nod last fall, and that new use won backing in influential guidelines published by the American Cardiology and American Heart Association in April. Since then, England’s cost-effectiveness watchdogs blessed the new use as well.
“We’re on track and are now the number one branded anti-platelet medicine in the U.S.,” AstraZeneca EVP Luke Miels said during the company’s second-quarter earnings call.
AstraZeneca had planned to submit the EUCLID data for a PAD indication in the first half of next year. With that plan on the ropes, and the stroke data unfavorable for a new use, pushing Brilinta in its current patient population is particularly important now, and AstraZeneca certainly plans to continue doing that. “The potential for the current indication is far from being exhausted,” Helfgott told Reuters.
That’s not to say that AZ is giving up on new uses for Brilinta. The company has other studies running, including a final outcomes study of the med. The 19,000-patient THEMIS trial is testing the drug in diabetic patients with coronary heart disease with no history of heart attack or stroke. Last quarter, the company wrapped up enrollment in that trial, which is set to read out in 2018.
by Tracy Staton | Oct 4, 2016