ASTRAZENECA REPLIES TO THE US FDA COMPLETE RESPONSE LETTER FOR BRILINTA (ticagrelor Tablets)

ASTRAZENECA REPLIES TO THE US FDA COMPLETE RESPONSE LETTER FOR BRILINTA
(ticagrelor Tablets)

 

AstraZeneca announced today it has replied to the US Food and Drug
Administration's (FDA) Complete Response Letter (CRL) received for the
ticagrelor (BRILINTA) New Drug Application (NDA) on 16 December 2010.

The additional analyses of the PLATO trial requested in the CRL focused
primarily on interactions between ticagrelor and high dose aspirin.
AstraZeneca believes these supplementary analyses support the hypothesis
that the apparent difference in treatment effect observed in the US and
non-US patient subsets in PLATO is most likely a reflection of an
underlying interaction between ticagrelor and higher doses of aspirin.

AstraZeneca remains of the view that either the play of chance or an
interaction between high dose aspirin and ticagrelor are viable
explanations for the efficacy differences observed in a subset of US
patients in the PLATO trial.

The CRL did not request that additional studies, including clinical
studies, be conducted as a prerequisite for approval of the ticagrelor
NDA.

According to the FDA's published guidance, following the issuance of a
CRL, resubmitted NDAs, once accepted by the FDA, are given one of two
classifications: Class 1 starts a two-month review cycle while Class 2
starts a six-month review. 

The FDA will now review AstraZeneca's response to determine whether the
information submitted is complete and whether to designate the review as
Class 1 or Class 2.

AstraZeneca remains confident in the NDA submission for ticagrelor and
will continue to work with the FDA to progress towards the completion of
the review of the NDA for ticagrelor.

-ENDS-

NOTES TO EDITORS

About BRILINTA (ticagrelor tablets)
BRILINTA is an oral antiplatelet treatment for acute coronary syndromes
(ACS). BRILINTA is a direct-acting P2Y12 receptor antagonist in a
chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA
is the first reversibly-binding oral ADP receptor antagonist.

BRILINTA is currently under regulatory review in 21 countries, including
in the US. The product has been approved in 30 countries, including in
the EU, Iceland, and Norway, under the trade name BRILIQUE and in Brazil
under the trade name BRILINTA.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of
companies.

About the PLATO study
PLATO was a large (18,624 patients in 43 countries) head-to-head patient
outcomes study of ticagrelor versus clopidogrel, designed to establish
whether ticagrelor could improve cardiovascular (CV) outcomes in ACS
patients, compared to clopidogrel. The NDA submission for ticagrelor is
based on the results of a comprehensive clinical trial programme,
including data from the PLATO study.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialisation
of prescription medicines. As a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory and inflammation, oncology and
infectious disease medicines, AstraZeneca generated global revenues of
US $32.8 billion in 2009.  For more information please visit:
www.astrazeneca.com (http://www.astrazeneca.com/)

CONTACTS:

Kristian Sjöholm, Media Team, mob: +46 733 35 14 26
Karl Hård, Investor Relations, +44 20 7604 8123, mob: +44 7789 654364