AstraZeneca receives patent extension for Armidex

AstraZeneca has announced that it has received a six month paediatric exclusivity patent extension from the US Food and Drug Administration for Armidex.

The pharmaceutical company has now been granted exclusivity to market its licensed breast cancer indications until June 2010 as opposed to December 2009.

Dr John Patterson, executive director of development at AstraZeneca, illustrated that clinical data supported the therapeutic potential of Armidex in paediatric conditions.

He highlighted that gynecomastia in pubertal boys and precocious puberty in girls with McCune-Albright Syndrome were two areas where potential for the use of Armidex was found.

Dr Patterson added: “While pleased to have been able to work with the FDA in investigating the potential benefits of Armidex in these settings, AstraZeneca will not be seeking an indication in either of these paediatric conditions based on trial results.”

Armidex is currently approved in the US for several different hormonal treatment options in postmenopausal women with breast cancer.

In the US, Armidex sales reached $507 million (245 million pounds) for the first nine months of 2007 with the drug having a market leading 38.3 per cent share of total of total prescriptions for hormonal treatments for breast cancer.

Also this month, AstraZeneca confirmed that the European Patent Office had ruled that the European patent for its MUPS formulation was still valid in its amended form.