AstraZeneca receives six months pediatric exclusivity patent extension for ARIMIDEX (anastrozole)

March 18, 2016

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 indications:

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 2005). 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.

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"We are very pleased to have advanced our ability to characterize MF101 by isolating this chemical compound and this new discovery will significantly strengthen our intellectual property position for our lead compound," added Isaac Cohen, chairman and CEO of Bionovo. "Given the increasing population of women entering menopause, and the lack of safe and effective treatments for these women, we are excited to be on the forefront of developing more selective and safer alternative drugs for this enormous indication."

MF101 is an oral drug designed for the treatment of hot flashes and night sweats in peri-menopausal and menopausal women. MF101 is a novel estrogen receptor beta selective agonist and unlike currently available hormone therapies, does not activate the estrogen receptor alpha, known to be implicated in tumor formation. Two hundred and seventeen women were enrolled into a double-blind, placebo-controlled, randomized Phase 2 clinical trial under the directorship of Dr. Deborah Grady in early 2007. Trial results showed that MF101 10 grams/day was statistically superior to placebo at reducing hot flashes and was extremely well tolerated with no serious side effects.

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