ASTRAZENECA RECEIVES FIRST REGULATORY APPROVALS FOR CASODEX™ 150MG IN EARLY PROSTATE CANCER

The UK is acting as the reference member state in a European Union recognition procedure and, within that procedure, approval for the new indication was also granted in Greece, Portugal and Austria. Licences in other European markets are anticipated.

These approvals are based on results from the worlds largest prostate cancer treatment trial that found that Casodex™ 150mg can significantly reduce (by 42 percent) the risk of the disease progressing in patients with early prostate cancer, when taken in addition to standard therapy (watchful waiting, radical prostatectomy or radiotherapy), when compared to standard care alone.

"The approval of Casodex™ 150mg is important for the thousands of patients who have, until this point, not had access to a drug therapy to treat their cancer until the disease had progressed," said Chris Brinsmead, Vice President, Oncology. "With these first approvals, AstraZeneca is now pleased to offer patients further treatment options across the various stages of prostate cancer."

Further regulatory submissions and approvals are anticipated, including in the US, where a submission is planned by the end of the year. In addition, licences have recently been granted for Casodex™ 150mg in Italy and Hungary, which also authorise its use in the early stages of prostate cancer.

In 2000, Casodex™'s worldwide sales of $433 m showed a 31 percent increase compared to the previous year. Casodex™ is one of five important AstraZeneca products, whose growth is being fuelled by life cycle initiatives.

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