Dr Brent Vose, Vice-President and Head of Oncology, at AstraZeneca said today, "As a leading Company in this area, we have been committed to cancer research for over 20 years and we are encouraged by the clinical progress made with 'Iressa'. It is anticipated that our collaboration with Pierre Fabre will expand the options available to cancer patients - especially the benefit of combining two oral therapies - and will enable us to further assess the potential role of 'Iressa' as a valuable new treatment."
Commenting on the collaboration, Pierre Fabre representatives said, "We are delighted to be working with AstraZeneca and we hope the combination of NAVELBINE® ORAL and 'Iressa' will provide patients with new treatment options in a number of different tumour types in the future."
'Iressa' is a once daily, orally active, selective EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor), which targets and blocks the activity of the EGFR-TK - an enzyme that regulates intracellular signalling pathways implicated in cancer cell proliferation and survival. Pivotal Phase II data demonstrate that 'Iressa' treatment leads to objective response or disease stabilisation in patients with NSCLC whose disease had progressed on previous treatments. Importantly, the results were achieved without the accompanying heavy side effect burden typically seen with lung cancer therapies. These data are currently under review with several Health Authorities including the FDA and MHLW. 'Iressa' is currently completing Phase III studies for the treatment of first line NSCLC in combination with chemotherapy and results from these important trials are expected later this year. Since receptors for EGF play a major role in the biology of cancer cells in many solid tumours, 'Iressa' offers potential for the treatment of a broad range of common solid malignancies and has entered Phase II clinical trials in a variety of tumours including breast, colorectal, head and neck, prostate and gastric cancers. 'Iressa' is not currently licensed in any country world-wide.
NAVELBINE® ORAL, in 20 mg and 30 mg capsules, is the first chemotherapy agent that has shown an efficacy for the oral form similar to that of the intravenous form for NSCLC.
NAVELBINE® I.V. is registered worldwide and is a widely used anti-cancer drug. 130 000 patients were treated with NAVELBINE® last year. NAVELBINE® is well recognized as a treatment for Non Small Cell Lung Cancer either as mono-chemotherapy, including also the management of elderly patients, or polychemotherapy. NAVELBINE® I.V. has also been widely studied within the framework of radio-chemotherapy combinations.
Tolerance of NAVELBINE® ORAL is comparable to that of NAVELBINE® I.V., but with an advantage due to its method of administration: that of avoiding possible damage to the patient's venous system. No new toxicity has been found as compared with the I.V. form.
Improving the quality of life for patients, NAVELBINE® ORAL marks the beginning of a new area in treatment of Non Small Cell Lung Cancer. NAVELBINE® ORAL is already registered and available in France, Portugal and Finland. Its registration file is under evaluation in several other European countries.
About AstraZeneca
With the development of 'Iressa', AstraZeneca continues in its tradition of research excellence and innovation in Oncology that led to the development of its current anti-cancer therapies including 'Arimidex', 'Casodex', 'Nolvadex', 'Tomudex' and 'Zoladex' as well as a range of novel targeted pipeline products such as anti-proliferatives, anti-angiogenesics, 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 $16.4 billion and leading positions in sales of oncology, gastrointestinal, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. Additional information about AstraZeneca is available at www.astrazeneca.com
About PFM
The second-largest independent pharmaceutical company in France, Pierre Fabre Médicament is largely spread over the International Market through its own subsidiaries and partners.
In 2001, turnover amounted to 493 M Euros (+ 7,6%), of which 45% was accounted for by non domestic sales.
Pierre Fabre Médicament support a strong and active Research and Development policy : 20 % of turnover is dedicated to new drug discovery in oncology, CNS and cardiovascular diseases, and immunology.
Pierre Fabre Oncologie is a specialized department of Pierre Fabre Médicament organised as a business unit specifically dedicated to the development (preclinical - clinical) and commercial activities of the Pierre Fabre Group in Onco-haematology.
NAVELBINE® I.V is already registered in Breast Cancer in most countries and among the most advanced development programs conducted by PFO must be emphasized new indications of NAVELBINE® I.V. in multiple myeloma and prostate cancer, the completion of the development program of NAVELBINE® ORAL and also the recent initiation of a complete Phase II program for Vinflunine (JAVLOR®), a new unique and potent Vinca-alkaloid discovered through PFO by its own research centers.
In order to meet ambitious objectives, PFO has set up a complete development and commercial network not only throughout Europe but also in South Africa and Australia.
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Louise Marland +44 (0)1625 510782
Emily Denney +44 (0)20 7304 5034
Steve Brown +44 (0)20 7304 5033
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Alexandrine Urbain +33 (0)1 49 10 81 33
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- Please visit the World Wide Web for further press information regarding IRESSA and other AstraZeneca cancer therapies at www.cancerpressoffice.com
- Please visit the World Wide Web for the information on Epidermal growth factor receptors (EGFR) and their potential role in the treatment of cancer at www.EGFR-INFO.com
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