Regulatory Approval

AstraZeneca PLC 4 September 2000 FDA APPROVES ARIMIDEX - A NEW FIRST LINE TREATMENT OPTION FOR BREAST CANCER AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved its breast cancer treatment Arimidex as a new treatment option for post-menopausal women first diagnosed with advanced or locally advanced breast cancer whose cancers are hormone receptive. Arimidex is the first aromatase inhibitor to be approved for first-line treatment in the U.S. Previously, Arimidex was only approved for use after disease progression following tamoxifen treatment. Two pivotal studies found that Arimidex was as effective and well tolerated as tamoxifen when prescribed at the time of diagnosis for women with advanced breast cancer. Arimidex was first approved in 1996 as a treatment for post-menopausal women with advanced breast cancer who progressed following hormonal treatment with tamoxifen. Arimidex is a non-steroid aromatase inhibitor, which works to lower the amount of circulating estrogens in the body. Earlier this year, the drug gained approval in several European countries for first-line use in post-menopausal women with advanced disease. Arimidex and tamoxifen work in very different ways. Arimidex stops the production of estrogen from the adrenal glands (near the kidneys) a main source of estrogen for post-menopausal women. Tamoxifen interferes with the cancer cell's ability to use estrogen for fuel to divide and grow. Arimidex is also currently being evaluated in comparison to tamoxifen as an adjuvant therapy for early breast cancer in a multinational trial called ATAC (Arimidex, Tamoxifen And Combination therapy) with results expected in 2001. AstraZeneca 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 US15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. 4 September 2000 Further enquires to: Michael Olsson: Tel. +44 (0)20 7304 5087 Ed Seage: Tel. +1 302 886 4065 Jorgen Winroth: Tel. +1 609 896 4148

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AstraZeneca (AZN)
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