New data on Astrazeneca oncology drugs to be presented at ASCO annual meeting

Breadth of Oncology Franchise Highlighted

New data on several AstraZeneca oncology products will be presented over the next several days at the American Society of Clinical Oncology (ASCO) 2001 annual meeting in San Francisco, California May 12-15. The data released will include research on AstraZeneca's existing anticancer therapies for prostate and breast cancer, as well as promising new treatments currently in development. Highlights include:

IRESSA® (ZD1839)
AstraZeneca recently announced completion of patient enrollment for Phase III IRESSA clinical trials in non-small cell lung cancer (NSCLC). After delivering promising Phase I results at ASCO last year, the development program for IRESSA for NSCLC was accelerated and the drug moved directly from Phase I to Phase III trials. Clinical studies are ongoing regarding the use of IRESSA for other solid tumors including research trials with the National Cancer Institute (NCI) slated to open in the next few months.

New research on IRESSA will be presented during this year's ASCO conference, including pre-clinical breast cancer data. Stacy L. Moulder, MD, will discuss the use of IRESSA against HER2/neu-overexpressing breast tumor cells on Saturday, May 12, as part of an integrated symposium entitled "Targeting the EGF Receptor: A Clinical Reality." Iain Hutcheson, MD, of Tenovus Centre for Cancer Research, Cardiff, UK, will present data showing IRESSA was active as an inhibitor in pre-clinical studies in tamoxifen-resistant breast cancer cell growth on Monday, May 14.

IRESSA is an oral drug that targets the epidermal growth factor receptor (EGFR) inhibiting tyrosine kinase (TK) activity. An over expression of EGFR-TK is found in many tumor types and clinical data suggests that excessive levels of EGFR-TK are linked to poor prognosis, including tumor invasion and development of metastatic (widespread) cancer.

FASLODEX® (fulvestrant)
A New Drug Application (NDA) for FASLODEX® (fulvestrant) was filed with the U.S. Food and Drug Administration (FDA) on March 28, 2001 for treatment of locally advanced or metastatic breast cancer in postmenopausal women who have previously progressed following hormonal therapy. FASLODEX is a new type of agent that works differently than other hormonal breast cancer drugs. Characterized as an Estrogen Receptor Downregulator, FASLODEX attacks breast cancer cells by targeting and degrading the estrogen receptor.

New research on FASLODEX will be presented during this year's ASCO conference by Nigel Bundred, MD, on Sunday, May 13, discussing pre-clinical data showing FASLODEX reduces cell turnover index to a greater extent than tamoxifen. Additionally, C. Kent Osborne, MD, of the Baylor College of Medicine and a principal investigator in the FASLODEX clinical trial will present "Selecting the Optimal Endocrine Therapy for Primary and Metastatic Breast Cancer" on Sunday, May 13, and Monday, May 14. AstraZeneca is committed to continued research on FASLODEX and is currently evaluating it in a head-to-head trial with tamoxifen for first line advanced breast cancer. Results are expected early next year.

ZD0473
ZD0473 is a new generation platinum cytotoxic (chemotherapy) analogue for the treatment of solid tumors and is currently in Phase II development with potential broad application for several tumor types. Platinum-based anti-cancer treatments are widely used in the treatment of solid tumors such as cancers of the lung, ovary and testes. These agents destroy cancer cells by binding to DNA, causing damage which, if too severe to be repaired by intracellular mechanisms, trigger programmed cell death (apoptosis). Many solid tumors initially respond to platinum-based treatment, but in most cases, the tumor cells become resistant to therapy and the disease recurs. ZD0473 was designed to overcome these resistance problems.

Abstracts at ASCO this year include Phase II data on the use of ZD0473 in ovarian cancer after initial chemotherapy failure, and data by Prof. Bonomi from the Rush-Presbyterian-St. Luke's Medical Center in Chicago on the use of ZD0473 for platinum resistant small-cell lung cancer.

ZD6474
ZD6474 is a novel orally active inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinase. ZD6474 disrupts a critical signaling pathway in tumor blood vessel formation (angiogenesis), a process essential to the growth of all solid cancers. ZD6474 has shown promising preclinical activity in a variety of tumor models.

Preliminary results of a Phase I dose-escalation study on the use of ZD6474 in patients with advanced solid tumors will be presented for the first time during this year's ASCO conference by Dr. Russell Basser on Saturday, May 12.

CASODEX® (bicalutamide)
Preliminary results from the world's largest ongoing prostate cancer trial, the Early Prostate Cancer (EPC) Trial Program, will be presented at ASCO on Saturday, May 12. The program is designed to determine whether adding CASODEX 150 mg to standard care (radical prostatectomy, radiation therapy, or watchful waiting) can reduce the risk of disease progression when compared to standard therapy alone, in patients with localized or locally advanced prostate cancer. The Early Prostate Cancer (EPC) Trial Program, which began in 1995, is an international program and includes over 8,000 patients from 23 countries around the world, including North America, Scandinavia, Europe, South Africa, Australia and Mexico.

CASODEX is an oral hormonal medication that interferes with the ability of prostate cancer cells to use male hormones to grow. CASODEX is currently used to treat advanced prostate cancer in combination with an LHRH-A medication.

ARIMIDEX® (anastrozole)
ARIMIDEX is a highly selective, potent, non-steroidal aromatase inhibitor used to treat post menopausal women with advanced breast cancer. Moise Namer, MD, will present information on aromatase inhibitors on Sunday, May 13 in a Meet the Professor program titled "How to Integrate the New Antiaromatases in the Treatment of Metastatic Breast Cancer." Additionally, new data will be featured on ARIMIDEX including treatment of visceral metastases (abstract 1835), affect on adrenal cortisol/aldosterone synthesis (abstract 1954), combination use with ZOLADEX (abstract 1937), clinical benefit compared with other aromatase inhibitors (abstract 2003), and an economic evaluation (abstract 192).

About Marketed Oncology Drugs:
CASODEX 150 mg is currently not approved in the United States. CASODEX 50 mg is indicated for use in combination therapy with a luteinizing hormone-releasing hormone analogue (LHRH-A), such as ZOLADEX® (goserelin acetate implant), for the treatment of Stage D2 metastatic carcinoma of the prostate. In clinical trials, the most commonly reported adverse events, regardless of causality, for CASODEX 50 mg plus an LHRH-A were hot flashes, pain, back pain, asthenia, constipation, pelvic pain, infection, nausea, dyspnea, peripheral edema, diarrhea, hematuria, and nocturia. Serum transaminase levels should be measured prior to starting treatment with CASODEX, at regular intervals for the first four months of treatment, and periodically thereafter.

ARIMIDEX is indicated for the treatment of postmenopausal women first diagnosed with advanced or locally advanced breast cancer whose cancers are hormone receptive or for women with disease progression following tamoxifen therapy. Patients must exclude pregnancy before taking ARIMIDEX as it may cause fetal harm when administered to a pregnant woman. Common side effects seen include hot flashes, nausea, and headache. Joint pain and stiffness have also been reported during treatment with ARIMIDEX. ARIMIDEX is administered orally, once daily as 1 mg tablets.

About AstraZeneca:
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 $15.8 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 billion healthcare business with more than 10,000 employees.

Source: AstraZeneca

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