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

WILMINGTON, Del., Nov. 29 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the United States (US) Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market ARIMIDEX(R) (anastrozole) for its licensed breast cancer indications until June 2010. Prior to pediatric exclusivity being granted by the FDA, the patent was due to expire in December 2009.

ARIMIDEX is currently approved in the US for the for the following indications:

-- The adjuvant treatment (treatment following surgery with or without

radiation) of postmenopausal women with hormone receptor positive early

breast cancer (Sub Part H approval granted in 2002, final approval in

2005).

-- The first-line treatment of postmenopausal women with hormone receptor

positive or hormone receptor unknown locally advanced or metastatic

breast cancer (granted in 2000).

-- The treatment of advanced breast cancer in postmenopausal women with

disease progression following tamoxifen therapy. Patients with hormone

receptor-negative disease and patients who did not previously respond

to tamoxifen therapy rarely responded to ARIMIDEX (granted in 1995).

Dr. John Patterson, Executive Director of Development at AstraZeneca said "Pre-clinical and clinical data supported the investigation of the therapeutic potential of ARIMIDEX in pediatric conditions that manifest symptoms resulting from increased estrogen production, for example: gynecomastia in pubertal boys and precocious puberty in girls with McCune-Albright Syndrome (MAS). While pleased to have been able to work with the FDA in investigating the potential benefits of ARIMIDEX in these settings, AstraZeneca will not be seeking an indication in either of these pediatric conditions based on trial results."

In the US, ARIMIDEX sales reached $507 million for the nine months of 2007. ARIMIDEX has a
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SOURCE AstraZeneca
Copyright©2007 PR Newswire.
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