AstraZeneca suffers a setback as trial shows Brilinta 'no better than aspirin' for stroke

AstraZeneca's headquarters in London--Courtesy of AstraZeneca

AstraZeneca's ($AZN) hopes of beefing up its heart drug Brilinta with a new indication took a major hit today after it released data showing the pill did not help stroke patients any better than a drug first discovered in the 19th century.

The Anglo-Swedish company published the top-line results of its SOCRATES study which was looking at patients with acute ischemic stroke or transient ischemic attack and whether taking two doses of Brilinta (also known as Brilique) 90 mg was better than a 100-mg daily aspirin.

Brilinta did not fare well and missed its primary endpoint of time to first occurrence of any event from the composite of stroke (ischemic or hemorrhagic), heart attack and death.

This means that a 40-cent tablet--first sold by Bayer in 1899--was just as good at helping patients as AZ's new drug that costs around $7 (before discounts) per daily treatment.

There was some good news however as fewer side effects were noted on the Brilinta side compared to aspirin--although this trend was not in the end statistically significant.

This will be a blow to AZ as it has hung much of its future sales growth on the drug, saying publically that its revenue stream from the treatment should hit $3.5 billion by 2023. "It's a setback but at this stage we are not providing any new guidance on the overall [$3.5 billion] number," Ludovic Helfgott, head of AstraZeneca's Brilinta business, told Reuters.

The drug is already approved in a number of countries to reduce the rate of adverse CV events in patients who have previously suffered a heart attack. Brilinta is also being studied in peripheral arterial disease, with data from this EUCLID trial expected later this year.

Brilinta has not had the type of revenue that AstraZeneca wanted and it will need new licenses to help shore up its middling sales trajectory.

It also rounds off a difficult few years for AZ that has contended with a number of late-stage failures since 2011, with many coming from oncology studies.

AZ in 2014 successfully saw off an attempted hostile takeover bid from Pfizer ($PFE) after convincing shareholders it could go independent.

Full results of the SOCRATES study will be made public in mid-May.

- see the release
- check out the Reuters coverage

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