Astrazeneca announces EU marketing approval for Faslodex(TM)

March 12, 2004

Alderley Park, UK, 12 March 2004: AstraZeneca announced today that it has received European marketing approval for its new breast cancer drug FASLODEXTM (fulvestrant). The novel drug is indicated for the treatment of postmenopausal women with receptor-positive locally advanced or metastatic breast cancer, for disease relapse or progression on or after therapy with an anti-oestrogen such as tamoxifen. 'Faslodex' has been launched in the USA since May 2002, and more recently in Brazil in July 2003.

Breast cancer affects 1 in 9 women at some point in their lives and although many tumours are detected early and treated successfully, a large number of women still go on to be diagnosed with advanced breast cancer. The goal of treatment for these women is to achieve an effective disease response and to enable the patient to maintain good quality of life for as long as is feasibly possible. Hormonal agents such as 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 treatment with these hormonal therapies and as a result there is a need for new agents to which tumours are not resistant. 'Faslodex' is an exciting new type of therapy, which brings new choices for women with advanced disease, extending the sequence of 'patient-friendly' hormonal therapies that can be used to control the disease.

'Faslodex' is a novel therapy, the first of a new type, with a unique mode of action. The new drug is an oestrogen receptor antagonist with no agonist effects that binds, blocks and degrades the oestrogen receptor in breast cancer cells. This mode of action is different to the aromatase inhibitors that work by reducing the amount of oestrogen in a woman's body. It is also different to tamoxifen, which blocks the oestrogen receptor but which also has some oestrogenic actions which can be associated with a number of unwanted side effects.

'Faslodex's' unique mode of action creates a new type of endocrine treatment for oestrogen receptor positive breast cancer - the first to be approved in the European Union since 1995.

'Faslodex' offers durable responses and has tolerability benefits compared with aromatase inhibitors and tamoxifen. 'Faslodex' is effective following disease progression on prior anti-oestrogen and aromatase inhibitor therapy; in addition both therapies are effective following 'Faslodex' therapy. 'Faslodex' therefore meets a key unmet need for women with advanced breast cancer, since it can be added in to the sequence of well-tolerated hormonal therapies and may delay the need to resort to cytotoxic chemotherapies with their well-recognised side effects.

As such, Faslodex brings a new effective option for physicians and a new 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.

Professor John Robertson, from the University of Nottingham, UK, welcomed the launch of 'Faslodex' and commented on the benefit that the new drug brings: "The arrival of this new type of treatment is particularly exciting as it brings with it new choices for postmenopausal women with the advanced stages of this devastating disease." He continued, "The addition of a new endocrine agent expands our options for endocrine treatment sequences, and potentially allows us to control the disease for longer. 'Faslodex' is likely to appeal to women as it may help delay the need for cytotoxic chemotherapies. In addition 'Faslodex' has a very good side effect profile and offers tolerability benefits over other standard endocrine therapies."

This is the first time AstraZeneca has submitted a MAA (Marketing Authorisation Application) via the European Centralised Procedure, which results in a single licence throughout the EU, Norway and Iceland, and additional countries when the number of EU member states expands in May 2004.

The approval of 'Faslodex' is based on data from two pivotal phase III trials,1,2 which compared the efficacy and tolerability of 'Faslodex' to that of the aromatase inhibitor 'Arimidex' (anastrozole) in the treatment of hormone sensitive advanced breast cancer in postmenopausal women who had previously been treated with anti-oestrogen therapy. These trials recently reported mature survival data, concluding that:
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For more information, please visit www.astrazenecapressoffice.com

Alison Wright - Oncology Global PR Manager, AstraZeneca
Tel: 44-1625-230-076
Fax: 44-7879-487-331
Email: alison.k.wright@astrazeneca.com

'Faslodex' is a trademark, the property of the AstraZeneca group of companies.

Notes to editors

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.

Since AstraZeneca released its first anti-cancer drug, 'Nolvadex' (tamoxifen), more than 25 years ago, investment in research has led to the discovery of new anti-cancer agents and other innovative therapeutic strategies which give AstraZeneca an extensive portfolio of developmental agents to complement the established product range. AstraZeneca's product range for breast cancer, include the following: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.

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 a sustained release formulation that is administered once monthly as an 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 been available in the USA since May 2002, for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-oestrogen therapy. In that time, 'Faslodex' has seen rapid uptake in clinical practice beyond expectation and has helped thousands of postmenopausal women with advanced breast cancer.

'Faslodex' works differently to other anti-oestrogen agents for breast cancer, in that it binds to the oestrogen receptor in the breast cancer cell, and this interaction results in loss of the cellular oestrogen receptor (down-regulation). 'Faslodex' attacks cancer cells that have grown resistant to current anti-oestrogen treatment options.Thousands of women are diagnosed with advanced breast cancer each year - advanced breast cancer is diagnosed when cancer that is originally confined to the breast is found in other parts of the body. More specifically, a woman is considered to have advanced disease when breast cancer cells also form a tumour in places such as the lungs, liver or bones. In locally advanced disease, the cancer involves spread to the tissues surrounding the breast, such as underlying muscles or skin, but not to distant organs. Extensive lymph node involvement is also counted as locally advanced disease.
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References:
1. C.K. Osborne, et al. Double-Blind, Randomized Trial Comparing the Efficacy and Tolerability of Fulvestrant Versus Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing on Prior Endocrine Therapy: Results of a North American Trial. Journal of Clinical Oncology 2002; 20(16).
2. A. Howell, et al. Fulvestrant, Formerly ICI 182,780, Is as Effective as Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing After Prior Endocrine Treatment. Journal of Clinical Oncology 2002; 20(16).
3. J.F.R. Robertson, et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women; A prospective combined analysis of two multicentre trials. Cancer 2003; 98: 229-238

Shire Health International

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