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Another failed trial knocks back AZ's plan to grow Brilinta

Rests hopes on ongoing diabetes study but looks set to fall short of $3.5bn annual target

AstraZeneca's hopes of expanding the uses of its antiplatelet drug Brilinta have taken another knock. Having failed a stroke trial earlier this year, the drug has now shown no benefit in peripheral artery disease (PAD).

Brilinta (ticagrelor) was unable to show any improvement over an older generic antiplatelet drug - clopidogrel - in the large-scale EUCLID trial, which enrolled almost 14,000 people with symptomatic PAD.

The results dash AZ's hopes of filing the drug for PAD in the first half of 2017 as planned, pegging back growth in a key product for the company is it tries to bring new drugs such as cancer candidates durvalumab and tremelimumab through to market.

Billed as the largest cardiovascular outcomes trial ever undertaken, the study pitted twice-daily Brilinta against a single daily dose of clopidogrel. Its failure comes after Brilinta was unable to show a benefit on outcomes in ischaemic stroke in the SOCRATES trial.

PAD is the third most common cause of cardiovascular complications (largely myocardial infarction and stroke) in the world, and patients tend to suffer a high degree of cardiovascular morbidity and mortality despite current treatment.

Putting a brave face on the verdict, AZ's chief medical officer Sean Bohen said that the "proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction patients are established and remain unchanged".

EUCLID's failure leaves AZ banking on the results of one final cardiovascular outcomes trial - the THEMIS study in patients with type 2 diabetes at high risk of cardiovascular events - to open a up a big new patient population for Brilinta. Data from that study is due next year.

In the meantime, the drug is performing well enough in its established indications, growing 48% to $395m in the first half of 2016 thanks in part to data showing a benefit of longer duration of therapy with the drug. There is still a long way to climb before it can reach AZ's target of $3.5bn in annual sales by 2023 set out by chief executive Pascal Soriot in the midst of Pfizer's failed takeover bid in 2014.

With stroke and PAD off the agenda, that now looks unreachable. Prior to the EUCLID revelation EvaluatePharma was predicting sales of the drug would reach $2.1bn in 2022, with $750m of that total coming from new indications such as PAD and diabetic patients.

Article by
Phil Taylor

4th October 2016

From: Research



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