AstraZeneca announces initiation of development programme for BRILINTA® reversal agent

Updates on BRILINTA development programme and data from cardiovascular portfolio to be presented at American Heart Association (AHA) Scientific Sessions 2014

AstraZeneca today announced that it has begun a pre-clinical development programme to evaluate the ability of investigational antibody, MEDI2452, to rapidly and specifically reverse the antiplatelet effects of ticagrelor (BRILINTA®) in rare emergency situations such as urgent surgery, or in the event of major bleeding. MEDI2452 is being developed by MedImmune, AstraZeneca’s biologics research and development arm.

“In certain emergencies, doctors need to have the option to swiftly reverse the effects of oral antiplatelet agents, in order to enable emergency surgery or a quick response to a major bleeding event without having to wait for the effects of the medicine to wear off. Currently there are no FDA approved medications to counteract the antiplatelet effect in these situations,” said Marc Ditmarsch, Global Development Lead for BRILINTA. “If the circumstances demand it, we believe MEDI2452 has the potential to help address this need for patients treated with BRILINTA.”

The development of MEDI2452 sits alongside the wider PARTHENON clinical programme for BRILINTA, which includes five registration studies involving around 80,000 patients across the broad spectrum of atherothrombotic disease. The PEGASUS-TIMI 54 study, involving more than 21,000 patients, will be the next study within the programme to complete, with top line results expected in the first quarter of 2015. PEGASUS-TIMI 54 aims to assess the efficacy and safety of ticagrelor (twice daily compared to placebo on a background of low-dose aspirin), for the long-term prevention of atherothrombotic events in patients, aged 50 and older, who suffered a heart attack one to three years prior to study enrolment, and who have one additional cardiovascular risk factor.

“Current guidelines generally recommend 12 months of dual antiplatelet therapy following an acute coronary syndrome event, however atherothrombotic disease is a chronic, progressive and in some cases fatal condition,” Marc Ditmarsch continued. “The PEGASUS trial will help us evaluate the potential long-term benefit of therapy with ticagrelor for the chronic condition. This will be important information for patients with a history of myocardial infarction and their physicians, to determine the management of their condition following a heart attack beyond 12 months.”

The initiation of the development programme for MEDI2452 comes ahead of the AHA Scientific Sessions, taking place in Chicago from 15-19 November 2014. AstraZeneca will present nine abstracts across its pipeline and marketed products at the meeting, as well as showcasing its strength in cardiovascular and metabolic diseases as a core therapy area.

Data to be presented includes:

• Results from a study comparing pharmacodynamic profiles of escalating loading dose regimens of BRILINTA, in patients with ST-elevation myocardial infarctions. Poster, Board #6002, 09:00-17:00 EST, Sunday 16 November, 2014.

• Data from the EVOLVE study, analysing the effect of EPANOVA on apolipoprotein CIII (a protein known to promote dyslipidemia) concentrations in high, low and very low density lipoproteins, in patients with moderate to severe hypertriglyceridemia. Poster, Board #2254, 09:00-17:00 EST, Sunday 16 November, 2014.

• Data from the JUPITER trial looking at lipoprotein subclass and size changes in response to treatment with CRESTOR, in order to identify predictors of diabetes. Poster, Board #2026, 09:00-17:00 EST, Monday 17 November, 2014.

The AHA Scientific Sessions come at a significant time for BRILINTA, with the recent update to the AHA and American College of Cardiology guidelines for the management of patients with non-ST-elevation acute coronary syndrome (NSTE-ACS), which will also be discussed at the meeting. The guidelines support differentiation among currently available P2Y12 inhibitors, including BRILINTA, clopidogrel and prasugrel for these patients. In a Class IIa recommendation, BRILINTA is now preferred over clopidogrel for the management of NSTE-ACS patients who undergo an early invasive (angiography with intent for percutaneous coronary intervention, if appropriate), ischaemia-guided (i.e. medically managed) strategy, or those who receive a coronary stent.

-ENDS-

NOTES TO EDITORS

About MEDI2452

MEDI2452 is a neutralising antibody that binds to ticagrelor and AR-C124910XX, the ticagrelor active metabolite, and is intended to reverse the antiplatelet effects of ticagrelor. The availability of MEDI2452 would allow better clinical management of the balance between the desired antithrombotic effect and prevention or control of bleeding. Ticagrelor is the only marketed reversibly binding platelet P2Y12 antagonist (van Giezen et al 2009).

About BRILINTA (ticagrelor)

BRILINTA (known as BRILIQUE® in the European Union) is an oral antiplatelet treatment for acute coronary syndrome (ACS). BRILINTA is a direct-acting P2Y12 receptor antagonist and first in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs), providing doctors with a different treatment option to the thienopyridine class of oral antiplatelets. It works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic cardiovascular (CV) events, such as a heart attack or CV death, in patients with ACS.

BRILINTA/BRILIQUE is a registered trademark of the AstraZeneca group of companies.

About the PARTHENON programme

AstraZeneca is currently collaborating with over 4,000 clinical investigators in more than 30 countries as part of the PARTHENON programme, and has established partnerships with a number of pre-eminent research institutions. In addition to PEGASUS, EUCLID, SOCRATES and THEMIS, are other ongoing studies for the treatment of patients with peripheral arterial disease (PAD), ischaemic stroke and transient iscaemic attack (TIA) and for the prevention of CV events in patients with diabetes and coronary atherosclerosis.

BRILINTA is currently not approved for the treatment of patients with ischaemic stroke, TIA, PAD, for the prevention of CV events in patients with diabetes and coronary atherosclerosis, or for secondary prevention in patients with a history of previous myocardial infarction.

About CRESTOR

CRESTOR (rosuvastatin calcium) is a statin used for the treatment of dyslipidaemia and hypercholesterolaemia. In some markets it is also indicated to slow the progression of atherosclerosis and to reduce the risk of first cardiovascular events.

CRESTOR has received regulatory approval in more than 100 countries worldwide and is backed by clinical research that spans 13 years, including over 120 ongoing or completed clinical trials and involving more than 67,000 patients worldwide.

CRESTOR is a registered trademark of the AstraZeneca group of companies.

About EPANOVA

EPANOVA is the first US FDA approved prescription omega-3 in free fatty acid form. The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option of as few as two capsules once a day, with or without food.

Triglycerides are a type of lipid (fat) found in blood and an essential energy source for the body. Some people have very high triglyceride levels (severe hypertriglyceridaemia), meaning they have too much fat in their blood which can lead to serious health complications. Nearly four million American adults currently have severe hypertriglyceridaemia and this figure continues to rise, as the prevalence of associated conditions, such as obesity and diabetes, continues to grow. EPANOVA is a pure, free fatty acid form that can provide physicians with an option to effectively manage the condition without dramatically increasing a patient’s pill burden.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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