Healthy Skepticism Library item: 12170

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: media release

AstraZeneca Receives Six Months Paediatric Exclusivity Patent Extension For ARIMIDEX From The FDA
AstraZeneca 2007 Nov 29
http://www.icaa.eu/company/AstraZeneca/article/37012.html

Abstract:

AstraZeneca today announced that the United States (US) Food and Drug
Administration (FDA) has granted an additional six month period of
exclusivity to market ARIMIDEX (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
Pre-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.

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.

Media Enquiries:
Steve Brown, +44 207 304 5033 (24 hours)
Edel McCaffrey, +44 207 304 5034 (24 hours)

Investor Enquiries:
Jonathan Hunt, +44 207 304 5087
Ed Seage, +1 302 886 4065
Karl Hard, +44 207 304 5322
Jorgen Winroth, +1 212 579 0506
Mina Blair, +44 20 7304 5084
Peter Vozzo, (MedImmune) +1 301 398 4358