AstraZeneca Gets Arimidex Extension

AstraZeneca said the FDA has granted it another six months of patent protection for its breast cancer drug Arimidex.

The patent extension through June 2010 was granted under pediatric exclusivity rules because the company conducted trials to investigate the drug’s potential for pediatric conditions with symptoms due to increased estrogen production. The company received the extension even though the drug did not pan out for these conditions, and the company will not be seeking a new licensed indication for them.

Arimidex (anastrozole) is approved in the U.S. for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.