“Lung Cancer is a complex and devastating disease and sadly, patients with advanced lung cancer have a poor prognosis and survival rates are often very low,” Brent Vose, Vice President and Head of Oncology at AstraZeneca commented. “Treatment options are still limited and new treatment approaches like IRESSA are urgently needed. The aim of treatment is to try to give patients precious extra quality of life and to relieve symptoms so that they can make the most of their time. The availability of IRESSA in Europe could help many patients achieve this goal and would represent a significant advancement for patients for whom no other therapies are approved.”

IRESSA is the first in a new class of anti-cancer drugs known as Epidermal Growth Factor Receptor (EGFR) inhibitors and was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of inoperable or recurrent NSCLC in July 2002. Sales for IRESSA in 2002 totalled $67 million.

The submission for IRESSA in Europe is based on data from two Phase II trials, IDEAL 1 and IDEAL 2 (IRESSA Dose Evaluation in Advance Lung Cancer). These data confirmed that IRESSA 250mg per day monotherapy provides clinically-significant anti-tumour activity in patients with previously treated advanced NSCLC. Results also provided further confirmation of IRESSA’s favourable safety profile, with the majority of side effects (diarrhoea and skin rash) reported as mild and reversible. Final results from these trials were presented internationally in September, 2002.

In the year 2000, there were approximately 370,000 new cases of lung cancer in Europe and more than 340,000 deaths from the disease. Only one in every 10 people with lung cancer is alive five years after diagnosis. The market for NSCLC is valued at $1.6 billion, and is forecasted to grow to $8 billion by 2011.

AstraZeneca continues its tradition of research excellence and innovation in oncology that led to the development of its current anti-cancer therapies including ARIMIDEX, CASODEX, FASLODEX, NOLVADEX, TOMUDEX and ZOLADEX, as well as a range of novel targeted products such as anti-proliferatives, anti-angiogenics, vascular targeting and anti-invasive agents. AstraZeneca is also harnessing rational drug design technologies to develop new compounds that offer advantages over current cytotoxic and hormonal treatment options. The company has over 20 different anti-cancer projects in research and development.

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 $17.8 billion and leading positions in sales of oncology, gastrointestinal, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.

IRESSA, ARIMIDEX, CASODEX, FASLODEX, NOLVADEX, TOMUDEX, ZOLADEX are trademarks, property of the AstraZeneca group of companies.