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Faslodex(R) (fulvestrant) Advanced Breast Cancer Treatment Data Presented In Journal of Clinical Oncology

Clinical Use of Faslodex for Advanced Breast Cancer Supported by Peer-Reviewed Publication of Pivotal Phase III Data

WILMINGTON, DE -- August 14, 2002 -- Results from two clinical trials evaluating Faslodex® (fulvestrant) Injection in treating advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy will be published in the August 15th edition of the peer-reviewed Journal of Clinical Oncology. The findings demonstrate Faslodex effectiveness and tolerability in comparison with Arimidex® (anastrozole), an aromatase inhibitor, for the treatment of advanced breast cancer. The articles follow the recent approval of Faslodex by the U.S. Food and Drug Administration (FDA) for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy, such as tamoxifen. The approval was based on data from the studies (Trials 20 and 21) discussed in these articles.

"Faslodex provides a new choice for patients progressing following tamoxifen therapy," said C. Kent Osborne, M.D., Baylor College of Medicine, Houston, Texas. "This published data, comparing Faslodex to an aromatase inhibitor, allows physicians to become better informed about Faslodex as a viable treatment option for postmenopausal women with advanced breast cancer."

Trial 21 was a randomized, double-blind, double-dummy, Phase III study carried out in North America. The trials were designed to compare Faslodex (250 mg per month) as an intramuscular injection with Arimidex 1 mg daily oral dose. Trial 20 was an open label, randomized, multicenter, Phase III study carried out in Europe, Australia, and South Africa. The two studies (Trials 20 and 21) were comprised of a total of 851 postmenopausal women with disease progression, following antiestrogen therapy, usually tamoxifen.

About Faslodex

Faslodex is currently approved by the FDA for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy (such as tamoxifen). Faslodex is administered as a once a month intramuscular injection in the buttock. Faslodex works by binding to estrogen receptors in breast cancer cells, blocking estrogen from binding and causing the estrogen receptor to change shape and become less functional.

Only postmenopausal women should take Faslodex. Faslodex may cause fetal harm when given to a pregnant woman. Because Faslodex is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants. In clinical studies, the most commonly reported side effects were hot flashes, gastrointestinal disturbances (nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back pain, and sore throat. Injection site pain and reactions have been reported but they were usually mild in nature.

AstraZeneca (NYSE: AZN - News) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $16.4 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 10,000 employees.

Editor Notes:

For full prescribing information on Faslodex and Arimidex, go to www.astrazeneca-us.com for more information. Additional information about Faslodex can be found at www.Faslodex.com .

Faslodex® is a registered trademark of the AstraZeneca group of companies.

Arimidex® is a registered trademark of the AstraZeneca group of companies.

This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2001.


SOURCE: AstraZeneca

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