AstraZeneca's Brilinta Doesn't Best Aspirin in Stroke Trial

  • Probability of success on tests was low, UBS analysts say
  • Data from Euclid tests to be released in second half of year

AstraZeneca Plc’s heart medicine Brilinta didn’t outperform aspirin in a three-month long test on preventing further attacks in patients who have suffered a stroke.

In a clinical trial dubbed Socrates, Brilinta taken twice daily was compared to a once-daily dose of aspirin in patients for two forms of stroke. Those taking the drug had fewer heart attacks, other stroke or death, but the difference wasn’t statistically significant, the London-based company said in a statement Wednesday.

Chief Executive Officer Pascal Soriot has identified Brilinta as critical to reaching $45 billion in annual revenue by 2023, a goal set in 2014 as AstraZeneca fended off a takeover attempt by Pfizer Inc. The anti-clotting medicine is sold as a treatment after heart attacks, but AstraZeneca is conducting studies intended to expand the population of patients who can take the pill.

The drugmaker’s forecast for Brilinta sales of $3.5 billion in 2023 won’t be affected by the Socrates results, Ludovic Helfgott, vice president of Brilinta, said in an interview. That figure took into account the risk of the drug failing to progress in clinical trials as a treatment for stroke, he said.

‘High Hurdle’

The Socrates trial had only a 50 percent probability of success, making it the most risky test under way for Brilinta, UBS Group AG analysts Alexandra Hauber and Mark Belsey wrote in a note today. The drug would have had estimated peak sales of $500 million for the stroke indication if it had been successful. They hadn’t included it in their earnings projections.

Shares of AstraZeneca rose 0.9 percent to 3,950.50 pence as of 1:50 p.m. in London trading. The stock has dropped 19 percent over the past year.

The full results of the stroke trial will be presented at a medical conference in May. While the top-line results aren’t promising, the complete data could yield details on the drug’s efficacy among patient sub-groups in the study.

"We set ourselves a very high hurdle there," said Elisabeth Bjork, vice president of global medicines development in cardiovascular and metabolic diseases. "The stroke patient population is a patient population of high unmet medical need, and in desperate need for new treatments, and that’s why we were looking to see if we could get enough benefit by treating these patients early on with Brilinta."

Expanding Scope

In spite of the setback for the stroke indication, the company remains confident about expanding the scope of Brilinta. Socrates is part of a larger program, dubbed Parthenon, that studies the effects of the drug in patients with peripheral arterial disease and diabetes.

"There are many other growth reservoirs and growth potential in the Brilinta franchise still standing," Helfgott said. Data expected in the second half of the year from a trial called Euclid will be important, he said.

That market could add $1 billion to Brilinta sales, Mark Purcell, an analyst at Barclays Plc, wrote in a note today.

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