George Blackledge, Vice President, Medical Director of Oncology, AstraZeneca commented, “With the high incidence of breast cancer in Europe, the introduction of FASLODEX would be welcomed by both physicians and patients fighting this debilitating disease. The submission in Europe is the first step in providing FASLODEX as a vital weapon in the treatment of advanced breast cancer for European women.”

Sales for FASLODEX in the US, its first market, were over $35 million following its launch in May of 2002. The breast cancer market in Europe is currently worth over $300 million. Breast cancer is the most common cancer among women in most European countries. Given current patterns of occurrence by age, about one in 12 women will develop the disease before the age of 75. There are approximately 345,000 new cases of breast cancer in Europe each year and an estimated 130,000 women per year will die of this devastating disease.

Two pivotal Phase III trials showed FASLODEX to be at least as effective as the aromatase inhibitor ARIMIDEX in the treatment of hormone sensitive advanced breast cancer in postmenopausal women who had previously been treated with prior endocrine therapy. FASLODEX is administered as a once monthly intramuscular injection, which may offer compliance benefits and, as an endocrine treatment, FASLODEX does not cause the side effects commonly associated with chemotherapy. The most commonly reported adverse reactions with FASLODEX, which occurred with a similar incidence to ARIMIDEX included hot flushes nausea, and headache. Injection site reactions, which were generally mild and transient, occurred with only 1 per cent of the injections when given as a single injection.

FASLODEX is a novel agent, an anti-oestrogen with no agonist activity that acts as an Estrogen Receptor Downregulator and is the first in a new class of treatments for breast cancer. FASLODEX targets, binds to, blocks and then degrades the oestrogen receptors in breast cancer cells unlike aromatase inhibitors, that reduce the amount of oestrogen in a woman’s body and tamoxifen, which blocks the oestrogen receptor.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (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, gastroenterology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.