"The speed with which the Japanese MHLW have approved 'Iressa' is very encouraging and reinforces our confidence in this drug as a crucial advance in the treatment of lung cancer," said Sir Tom McKillop, Chief Executive Officer, AstraZeneca PLC. "With the US approval expected in the second half of this year, and further markets to follow, 'Iressa' will play a crucial role in AstraZeneca's business transformation moving forward."

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 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.

Commenting on today's announcement from the MHLW, lead 'Iressa' trial investigator, Dr. M. Fukuoka, from the Kinki University School of Medicine, Osaka, Japan, said, "The introduction of 'Iressa' in Japan will be welcomed by both physicians and patients fighting this devastating disease. Most people already have advanced lung cancer by the time they are diagnosed, and even with the best treatment available at present, only 1 in 10 people with lung cancer will survive 5 years, compared with almost three quarters of women with breast cancer, so new treatment options like 'Iressa' are desperately needed. We know that 'Iressa' can benefit non-small cell lung cancer patients, and that it is well tolerated. Patients will be able to take 'Iressa' as a tablet and will not be subjected to the same side effects seen with chemotherapy."

'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.

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 top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of oncology, gastrointestinal, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.