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
-- 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
-- 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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