EU Committee for Orphan Medicinal Products Recommends Orphan Drug Designation for ZD6474 (ZACTIMA[TM]) for the Investigation of a Rare Form of Thyroid Cancer

    Alderley Park, England (ots/PRNewswire) - AstraZeneca announced today that it has received positive opinion from the Committee for Orphan Medicinal Products (COMP) recommending orphan drug designation for ZD6474 (ZACTIMA(TM)) for the treatment of patients with medullary thyroid cancer in the European Union (EU). Final adoption of the opinion is expected from the European Commission in early 2006.

    ZD6474 is a once-daily oral therapy that selectively targets key cell signalling pathways involved in tumour growth and spread including VEGF (Vascular Endothelial Growth Factor) receptor signalling and EGF (Epidermal Growth Factor) receptor signalling. ZD6474 also inhibits RET kinase, which drives the growth and survival of certain tumours, and is believed to be an important pathway in medullary thyroid cancer.

    "The COMP's recommendation adds further momentum behind the development of ZD6474 and represents a major step forward in the EU orphan drug designation process," said Peter Langmuir MD, Senior Medical Science Director, AstraZeneca. "EU orphan drug designation would offer hope for patients in Europe with medullary thyroid cancer, where treatment options are limited and the prognosis is poor."

    A recent presentation of preliminary results from a Phase II study during the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November 2005 showed promising clinical data with ZD6474 (ZACTIMATM) in patients with hereditary medullary thyroid cancer(1). A  Phase II study evaluating the anti-tumour efficacy and safety of ZD6474  in patients with advanced hereditary medullary thyroid cancer is currently  ongoing and continues to recruit patients.

    EU orphan drug designation was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the European Union.

    Thyroid cancer affects 240,989 individuals in Europe(2). Current treatments for thyroid cancer include surgery, radioactive iodine, hormone  treatment, external radiation or chemotherapy. Medullary thyroid cancer is  a specific form of the disease accounting for 5-8% of the 25,000 new cases  of thyroid cancer in Europe each year.2 Advanced hereditary medullary  thyroid cancer, a rare malignancy, has a poor prognosis and there are  currently very limited therapeutic options available. Neither standard  chemotherapy regimens, nor radiation therapy, provide substantial benefits  for patients with advanced hereditary medullary thyroid cancer.

    ZD6474 received U.S. FDA orphan drug designation in October 2005 for patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer, the first oncology orphan drug designation AstraZeneca has received.

    ZACTIMA(TM) (ZD6474) is a trademark of the AstraZeneca group of companies.

    About ZD6474 (ZACTIMATM)

    ZD6474 targets tumour blood supply, by inhibiting VEGFR (vascular endothelial growth factor receptor) tyrosine kinase, and directly targets tumour cells, by inhibiting EGFR (epidermal growth factor receptor) and RET tyrosine kinases. ZD6474 is currently being developed in a Phase II clinical trial in medullary thyroid cancer. In July 2005, AstraZeneca announced its intention to progress into Phase III studies evaluating the anti-tumour activity of ZD6474 in advanced non-small cell lung cancer (NSCLC). ZACTIMA(TM) (ZD6474) is a trademark of the AstraZeneca group of companies.

    About AstraZeneca

    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 world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

    For more information about AstraZeneca, please visit:


    1. Wells S et al. The Use of ZACTIMA(TM) (ZD6474) in the Treatment of Patients with Hereditary Medullary Thyroid Carcinoma. Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, November 2005.

    2. J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide.

ots Originaltext: AstraZeneca
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