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 market leading 38.3 percent share of total prescriptions for hormonal treatments for breast cancer. Sales for the nine months were up 15 percent, with total prescriptions 6 percent higher than last year.
Important Safety Information
Prescription ARIMIDEX is only for postmenopausal women. Do not take ARIMIDEX if you are pregnant because it may harm your unborn child.
In the early breast cancer clinical trial, common side effects seen with ARIMIDEX include hot flashes, joint symptoms, weakness, mood changes, pain, sore throat, nausea and vomiting, depression, high blood pressure, osteoporosis, swelling of the arms/legs, and headache. Fractures (including fractures of the spine, hip, and wrist) occurred more frequently with ARIMIDEX than with tamoxifen (10% vs 7%).
Common side effects seen with ARIMIDEX in advanced breast cancer studies include hot flashes, nausea, decreased energy and weakness, pain, and increased cough. Joint pain and stiffness have also been reported in association with the use of ARIMIDEX.
ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million 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.
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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
-- 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
-- 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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