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AstraZeneca Receives Six Months Pediatric Exclusivity Patent Extension for ARIMIDEX(R) (anastrozole) from the FDA
Date:11/29/2007

on patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com

Notes To Editors:

-- AstraZeneca submitted a proposed pediatric study request to the United

States Food and Drugs Administration (FDA) in 1999, in response to

which the FDA issued a Written Request, which outlined four clinical

studies to investigate the potential health benefits of ARIMIDEX in two

pediatric conditions: gynecomastia in pubertal boys and precocious

puberty in girls with McCune-Albright Syndrome (MAS). The purpose of

these studies was to examine the safety, efficacy and pharmacokinetics

of ARIMIDEX in these pediatric populations where an unmet need

currently exists.

-- The outcomes of the studies were that:

-- Study 0006 (gynecomastia) did not show any evidence for an effect of

ARIMIDEX versus placebo in the treatment of moderate-to-severe

pubertal gynecomastia;

-- Study 0046 (McCune Albright syndrome) suggested that ARIMIDEX does

not demonstrate a clear benefit in the treatment of precocious

puberty in the heterogeneous population of girls with the rare

disease of MAS. There was no observed benefit in terms of reducing

the frequency of vaginal bleeding, decreasing the rate of increase

in bone age or reducing growth rate in the overall group.


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SOURCE AstraZeneca
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