AstraZeneca Receives Six Months Paediatric Exclusivity Patent Extension For ARIMIDEX From The FDA
AstraZeneca today announced that the United States (US) Food and Drug Administration (FDA) has granted an additional six month period of exclusivity to market ARIMIDEXÂ® (anastrozole) for its licensed breast cancer indications until June 2010. Prior to paediatric 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 of postmenopausal women with hormone receptor positive early breast cancer (granted in 2002).
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 (granted in 1995).
Dr John Patterson, Executive Director of Development at AstraZeneca said â€œPre-clinical and clinical data supported the investigation of the therapeutic potential of ARIMIDEX in paediatric conditions that manifest symptoms resulting from increased oestrogen 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 paediatric conditions based on trial results.â€
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.
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.
Notes To Editors
AstraZeneca submitted a proposed paediatric 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 paediatric 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 paediatric 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.