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AstraZeneca Heart Drug Brilinta Fails a Study; Shares Down


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AstraZeneca PLC (AZN - Analyst Report) announced that its heart medicine Brilinta did not meet the primary endpoint in EUCLID trial for a new indication in peripheral artery disease (PAD). Shares slipped more than 1% on Tuesday.

Brilinta (90 mg) is presently marketed for the reduction of the rate of cardiovascular death, myocardial infarction (MI) and stroke in patients suffering from acute coronary syndrome (ACS) or with a previous history of MI.

The large-scale cardiovascular (CV) outcomes trial (n=13,885) evaluated Brilinta 90mg tablets twice daily versus clopidogrel 75mg once daily for the prevention of atherothrombotic events such as CV death, heart attack or ischaemic stroke in patients with symptomatic PAD. Top-line results showed that Brilinta failed to demonstrate a benefit over clopidogrel. The primary endpoint of the study was the time of first occurrence of any such event. Clopidogrel is the generic name of Sanofi's (SNY - Analyst Report) drug Plavix, which is now off patent.

The trial was run for AstraZeneca by The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, Durham, NC.

AstraZeneca had previously forecasted Brilinta to generate sales of approximately $3.5 billion by 2023. It delivered sales of $619 million in 2015.

The candidate is also being evaluated for the treatment of type II diabetes patients with coronary artery disease, but without a previous history of MI or stroke (outcomes study – THEMIS). Results from the THEMIS trial are expected in 2018. Moreover, Brilinta is being evaluated for the prevention of vaso-occlusive crises in pediatric patients with sickle cell disease (HESTIA).

In a separate press release, AstraZeneca announced that it has sold the U.S. rights to the branded as well as authorized generic verison of its older beta-blocker heart medicine Toprol-XL to Aralez Pharmaceuticals Inc. for an upfront payment of $175 million.

Toprol-XL is presently approved for the control of hypertension (high blood pressure), angina (chest pain) and heart failure. The authorized generic version of the medicine is marketed by Par Pharmaceuticals. Aralez will also pay up to $48 million in milestone and sales-related payments, as well as mid-teen percentage royalties on sales. AstraZeneca will continue to manufacture and supply Toprol-XL and the authorized generic medicine to Aralez. The transaction is expected to complete in the fourth quarter of 2016.

Earlier this week AstraZeneca announced that it has out-licensed the global rights to develop and commercialize MedImmune’s experimental drug MEDI2070 to Allergan plc (AGN - Analyst Report) for an upfront payment of $250 million. MedImmune is AstraZeneca’s global biologics research and development arm.

Other than the upfront payment, Allergan owes potential additional payments of up to $1.27 billion to AstraZeneca, should MEDI2070 hit certain product development and sales milestones.

MEDI2070 is presently in a phase IIb study for the treatment of patients with moderate-to-severe Crohn's disease. It is also ready to start phase II trials for ulcerative colitis with potential across a number of inflammatory and autoimmune disorders.

AstraZeneca has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank stocks here.

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