BRILIQUE (TICAGRELOR) POSITIVE EU CHMP OPINION


BRILIQUE (TICAGRELOR) RECEIVES POSITIVE EUROPEAN UNION CHMP OPINION FOR EXTENDED
TREATMENT OF PATIENTS with a history of heart attack

AstraZeneca today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion
recommending approval of BRILIQUE (ticagrelor) 60mg for the treatment of
patients with a history of heart attack and at high risk of having a further
atherothrombotic event. The opinion states that, treatment may be started as
continuation therapy after an initial one‑year treatment with dual anti platelet
therapy.

BRILIQUE 90mg is currently approved in the EU to reduce the rate of
cardiovascular death, myocardial infarction (MI, also known as heart attack) and
stroke in patients with acute coronary syndrome (ACS).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief
Medical Officer at AstraZeneca, said: “We are very pleased with today’s positive
opinion from the CHMP. Evidence shows that patients continue to be at risk of
experiencing a subsequent cardiovascular event beyond the first year after their
heart attack and we strongly believe in the role BRILIQUE can play in reducing
this risk for patients both in the acute setting and in the longer term.”

Commenting on the positive opinion, Professor Philippe Gabriel Steg, Professor
of Cardiology at the University of Paris, said: “The potential approval of 60 mg
dose for ticagrelor (BRILIQUE) in Europe provides an opportunity for prolonged
protection against cardiovascular events in patients at highest risk with an
optimised risk/benefit ratio.”

The positive CHMP opinion was based on the results from the PEGASUS TIMI-54
study (http://www.astrazeneca.com/Media/Press-releases/Article/20150314–pegasus
-timi-54-study-shows-that-longterm-treatment-BRILINTA-reduced-CV-events)1, a
large-scale outcomes trial involving more than 21,000 patients, presented at
American Cardiology Congress (ACC) in March 2015. PEGASUS TIMI-54 investigated
ticagrelor tablets plus low-dose aspirin, compared to placebo plus low dose
aspirin, for the long-term prevention of cardiovascular (CV) death, heart attack
and stroke in patients who had experienced a heart attack one to three years
prior to study enrollment. The study showed that BRILIQUE significantly reduced
the primary endpoint of CV death, MI or stroke compared to placebo. The rates at
3 years were 7.77% in the ticagrelor 60mg arm and 9.04% in the placebo arm.

The CHMP’s positive opinion on BRILIQUE will now be reviewed by the European
Commission, which has the authority to approve medicines for the European Union.
The final decision will be applicable to all 28 European Union member countries
plus Iceland, Norway and Liechtenstein. If approved, BRILIQUE will be the first
oral antiplatelet approved in these markets for the long term treatment of
patients with a history of heart attack.

Today’s announcement follows the approval (https://www.astrazeneca.com/our
-company/media-centre/press-releases/2015/us-fda-approves-brilinta-long-term-use
-heart-attack-history-patients-03092015.html) on 3 September 2015 of BRILINTA
(ticagrelor) 60mg by the US Food and Drug Administration, to be used in patients
with a history of heart attack beyond the first year.

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 diseases in three main therapy areas –
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology – as well as in infection and
neuroscience. 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

CONTACTS

Media Enquiries
Esra Erkal-Paler UK/Global +44 20 7604 8030
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen Oncology +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA – Respiratory, Inflammation and Autoimmunity, CVMD – Cardiovascular and
Metabolic Disease,

ING – Infection, Neuroscience and Gastrointestinal

18 December

-ENDS-

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