FEDERAL COURT OF CANADA RULES ON APPLICATIONS FOR GENERIC ESOMEPRAZOLE MAGNESIUM

FEDERAL COURT OF CANADA RULES ON APPLICATIONS FOR GENERIC ESOMEPRAZOLE
MAGNESIUM

For immediate release: 17 June 2010 

AstraZeneca today announced that the Federal Court of Canada has
dismissed AstraZeneca's request to prohibit the Canadian Minister
of Health from issuing a Notice of Compliance (NOC) for the regulatory
applications for generic esomeprazole magnesium submitted by Apotex
Inc. As a result, the Canadian Minister of Health is now free to issue
an NOC to Apotex, if their regulatory submissions are in an
approvable form, prior to the expiration of NEXIUM's Canadian patents.

In a Canadian proceeding seeking prohibition of an NOC, a presiding
court does not rule on the validity of patents, and this decision has no
bearing on cases in other jurisdictions. The proceedings, under the
Patented Medicines Notice of Compliance Regulations, are summary in
nature and involve no discovery process or witness testimony in court.

AstraZeneca is reviewing the ruling, which relates to only one of
NEXIUM's Canadian patents, and evaluating its options. AstraZeneca's
options include initiating a comprehensive patent infringement action. 
The company will continue to vigorously defend its intellectual property
for NEXIUM.

After receiving the Court's decision, Apotex must obtain an NOC or
regulatory approval from the Minister of Health before being able to
launch a generic esomeprazole magnesium product in Canada. Any launch
prior to patent expiration would be ‘at-risk' and subject to a patent
infringement action by AstraZeneca. AstraZeneca has many patents
protecting NEXIUM in Canada, including Canadian patent number 2139653. 
AstraZeneca's patents protecting NEXIUM in Canada expire between 2013
and 2019.

NEXIUM sales in Canada in 2009 were $217 million (USD). In the event of
a near term ‘at risk' launch of generic esomeprazole magnesium in Canada
the company does not expect to alter its 2010 Core EPS guidance range of
$6.05-$6.35. 

- ENDS -

NOTES TO EDITORS: 

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/)  

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