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| 12 March 2004 | 2004-03-12T00:00:00.0000000-00:00 |
| MARKETING APPROVAL GRANTED FOR FASLODEX™ (FULVESTRANT) IN EUROPEAN UNION
AstraZeneca announced today that it has received European marketing approval for its new breast cancer drug FASLODEX™ (fulvestrant). ‘Faslodex’ is indicated for the treatment of advanced breast cancer in post-menopausal women whose cancer has progressed on previous anti-oestrogen treatments such as tamoxifen. This is the first new type of treatment for hormone receptor positive advanced breast cancer to be approved in the European Union since 1995. | In November 2003, AstraZeneca announced that it had received a positive opinion on EU marketing approval for ‘Faslodex’ from the Committee for Proprietary Medicinal Products (CPMP), scientific advisory body to the European Commission. This was the first time AstraZeneca had submitted a Marketing Authorisation Application (MAA) via the European Centralised Procedure, which now results in a single license for ‘Faslodex’ throughout the EU, Norway and Iceland, and additional countries when the number of EU member states expands in May 2004. Following this formal EU approval, AstraZeneca expects first launches of ‘Faslodex’ in Europe in the second quarter, 2004.
‘Faslodex’ is a novel therapy, with a unique mode of action. It is an oestrogen receptor antagonist with no agonist effects, which binds, blocks and degrades the oestrogen receptor in breast cancer cells. This mode of action is different to aromatase inhibitors that work by reducing the amount of oestrogen in a woman’s body. ‘Faslodex’ is also different to tamoxifen, which blocks the oestrogen receptor, but has some oestrogenic actions that can be associated with a number of unwanted side effects.
The European submission for ‘Faslodex’ was based on data from two pivotal phase III trials, which compared its efficacy and tolerability to that of ‘Arimidex’ (anastrozole) in the treatment of hormone sensitive advanced breast cancer in postmenopausal women who had previously been treated with prior endocrine therapy.
Hormonal agents such as the aromatase inhibitors and tamoxifen are standard therapy in postmenopausal women with advanced breast cancer, providing an effective and well-tolerated treatment option. However, in time, tumour cells can grow resistant to these hormonal therapies and, as a result, there is a need for new, alternative agents that tumours are not resistant to. ‘Faslodex’ brings a new effective treatment option for physicians and gives hope to the thousands of postmenopausal women with oestrogen receptor positive advanced breast cancer, whose disease has recurred or progressed on prior anti-oestrogen therapy.
‘Faslodex’ was first launched in the USA in May 2002, and subsequently in Brazil in July 2003. During 2003, ‘Faslodex’ annual sales in the US reached $77 million. The endocrine breast cancer market in Europe is currently worth over $300 million.
Media Enquiries:
Steve Brown, +44 207 304 5033
Edel McCaffrey, +44 207 304 5034
Investor Enquiries:
Mina Blair-Robinson, +44 207 304 5084
Jonathan Hunt, +44 207 304 5087
Notes to Editors:
· 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. These statistics reinforce the necessity for new, effective treatment options to help combat this disease.
· Advanced breast cancer is diagnosed when the tumour has spread to the skin of the breast, local lymph nodes extensively or underlying tissues of the chest wall (locally advanced disease) or when the cancer has spread to sites/other organs beyond the breast (metastatic disease).
· Fulvestrant, marketed as ‘FASLODEX’, is licensed for the treatment of post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen.
· ‘Faslodex’ is administered as a once a month intramuscular injection, which may offer compliance benefits and since it is an endocrine treatment, it does not cause the side effects commonly associated with chemotherapy.
· ‘Faslodex’ has a unique mode of action, working differently to other endocrine agents for breast cancer. ‘Faslodex’ is effective in cancer cells that have grown resistant to current antioestrogen treatment options.
· 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 $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
· AstraZeneca continues its tradition of research excellence and innovation in oncology that led to the development of its current anti-cancer therapies including ‘ARIMIDEX’ (anastrozole), ‘CASODEX’ (bicalutamide), ‘FASLODEX’ (fulvestrant), ‘NOLVADEX’ (tamoxifen), ‘ZOLADEX’ (goserelin), ‘TOMUDEX’ (raltitrexed) and ‘IRESSA’ (gefitinib), 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.
‘FASLODEX’, ‘ARIMIDEX’, ‘CASODEX’ ‘NOLVADEX’, ‘TOMUDEX’, ‘ZOLADEX’ and ‘IRESSA’ are trademarks of the AstraZeneca group of companies
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