Iressa In Japan

AstraZeneca PLC 5 July 2002 ASTRAZENECA SECURES FIRST MARKET APPROVAL FOR IRESSA(TM) IN JAPAN AstraZeneca announced today that 'Iressa' (ZD1839) 250 mg once daily has received approval for the treatment of inoperable or recurrent non-small cell lung cancer (NSCLC) from the Japanese Ministry of Health, Labour and Welfare (MHLW), making Japan the first country worldwide to licence the drug. 'Iressa' is the first in a new class of anti-cancer drugs, known as Epidermal Growth Factor Receptor (EGFR) inhibitors, to become commercially available. The Japanese regulatory authorities have recently re-engineered the new drug application review procedure, which historically has been seen as somewhat slower than other regulatory bodies worldwide. The 'Iressa' review, which is the fastest on record (besides that for an AIDS treatment), is among the first to benefit from the new system. 'Iressa' will be the first drug in the world to be simultaneously developed in Japan, the United States and Europe, and launched in Japan first. AstraZeneca is the second fastest-growing major pharmaceutical company and ranks first in the oncology market in Japan, the world's second largest pharmaceutical market. NSCLC killed close to a million people worldwide in 2000 alone. Each year in Japan, there are 50,000 patients with NSCLC, of which 43,000 will die. The Japanese MHLW is forecasting an 80 per cent increase in the incidence of lung cancer in Japan over the next 15 years. The worldwide market for lung cancer is currently worth approximately $1.6 billion, the majority of which is accounted for by NSCLC, and is scheduled to grow to $8 billion by 2011. AstraZeneca anticipates full reimbursement for 'Iressa' by the end of the third quarter. Product launch is expected in the second half of this year in the United States, while regulatory reviews in Switzerland and Australia are currently underway. The first approval of 'Iressa' is based on data from two pivotal phase II trials, IDEAL 1 and 2. Results from these studies confirm 'Iressa' as an effective treatment for many patients with inoperable or recurrent advanced NSCLC, with an acceptable tolerability profile with the majority of side effects (diarrhoea and skin rash) reported as mild and reversible. 'Iressa' is administered as a once daily, oral tablet. 'Iressa' is leading a new class of anti-cancer drugs known as epidermal growth factor receptor (EGFR) inhibitors. This targeted mode of action is different from cytotoxic chemotherapies and 'Iressa' is not causally associated with the same types of side effects such as alopecia, neutropenia or other haematological toxicity. Within the cell, 'Iressa' targets and blocks signalling pathways that are implicated in the growth and survival of cancer cells. These pathways appear to play a major role in the growth of many solid tumours; therefore, Iressa may have therapeutic potential in a broad range of common cancers. 'Iressa' is a trademark of the AstraZeneca group of companies. Date: July 5, 2002 Media Enquiries: Emily Denney, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Mina Blair Robinson, Tel: +44 (0) 207 304 5084 - Ends - This information is provided by RNS The company news service from the London Stock Exchange

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