Submission of data to the Japanese Ministry of Health, Labour and Welfare (MHLW) supporting use of IRESSA for the treatment of NSCLC is scheduled to take place early in 2002.

Dr. Tom McKillop, Chief Executive Officer of AstraZeneca, said: “The submission of these data in the US and Japan are important steps in bringing IRESSA to market. AstraZeneca expects to launch the treatment from the middle of next year (2002)”.

NSCLC is a devastating disease where the majority of patients are diagnosed with advanced or metastatic disease. Chemotherapy is currently the only systemic treatment available. When approved, IRESSA will offer an additional treatment option for patients with NSCLC, and survival data of IRESSA in combination with chemotherapy are expected to be presented next year.

The clinical packages are based on data from two phase II trials involving over 400 patients worldwide, which demonstrated that IRESSA at a dose of 250 mg/day leads to objective response or disease stabilisation in previously treated patients with advanced non-small cell lung cancer (NSCLC), and is generally well tolerated. In many patients, treatment with IRESSA also produced rapid and prolonged relief of disease-related symptoms including patient-reported shortness of breath, coughing and chest tightness. In the majority, this improvement was reported within the first one to two weeks of treatment.

Lung cancer is becoming more prevalent. In 2000, there were an estimated 162,100 lung cancer deaths in the US alone. The five-year relative survival rate for all stages of lung cancer combined is only 15 per cent. The worldwide market for medicines to treat lung cancer is currently worth approximately $1.6 billion, the majority of which is accounted for by NSCLC. In Japan, the MHLW is forecasting an 80 per cent increase in the incidence of lung cancer in the next 15 years.

IRESSA is the first in a new class of anti-cancer drugs known as small molecule, selective EGFR-TKIs (epidermal growth factor receptor-tyrosine kinase inhibitors). IRESSA has a mode of action distinct from cytotoxic chemotherapies, and is administered as a once daily, oral tablet.

IRESSA targets and blocks, within the cell, 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 in Phase II clinical trials in a variety of tumours including breast, colorectal, gastric and hormone refractory prostate 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 $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.