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FDA Grants AstraZeneca Orphan-Drug Designation For ZACTIMA (ZD6474) Being Investigated For The Treatment Of Thyroid Cancer

Published: Oct 31, 2005

WILMINGTON, Del., Oct. 31 /PRNewswire-FirstCall/ -- AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation for ZACTIMA(TM) (ZD6474) for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer. ZACTIMA is designed to be a multitargeted compound, directed to the inhibition of key cell signaling pathways involved in tumor growth and spread. Tumor cells are targeted through inhibition of epidermal growth factor receptor (EGFR) and RET tyrosine kinases, while tumor blood supply is targeted through inhibition of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase. RET tyrosine kinase activity is an important growth driver in certain thyroid tumors.

"AstraZeneca has been dedicated to the fight against cancer for over 30 years," said Peter Langmuir, MD, Senior Director, Medical Science, AstraZeneca. "We are committed to delivering medicines that extend and improve the lives of people with cancer, and we are pioneering the development of novel medicines to treat many types of cancer."

ZACTIMA is an investigational drug being evaluated in Phase II clinical trials in medullary thyroid cancer and Phase III clinical trials in advanced non-small-cell lung cancer.

Orphan-drug designation was designed to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions, specifically, those that affect less than 200,000 people in the United States. ZACTIMA is the first oncology orphan-drug designation AstraZeneca has received.

According to the American Cancer Society, nearly 26,000 people in the United States will be diagnosed with thyroid cancer this year. Current treatments for thyroid cancer include surgery, radioactive iodine, hormone treatment, external radiation or chemotherapy.

AstraZeneca is currently enrolling patients in a ZACTIMA study in locally advanced or metastatic hereditary medullary thyroid cancer at Duke University in Durham, NC. For more information on this trial, please call 919-668-3533.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.

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 2004.

AstraZeneca

CONTACT: Katie Neff, AstraZeneca, +1-302-885-9960,katie.neff@astrazeneca.com

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