AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers

Reference code :: wf5182
Published date :: 31 October 2005
Expired date :: 18 March 2033

AstraZeneca announced today that the US Food and Drug Administration (FDA) has granted ZD6474 (ZACTIMA™) Orphan Drug designation for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer. ZD6474 is a unique 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.

ZD6474 is currently being developed in a Phase II clinical trial in medullary thyroid cancer and Phase III clinical trials in advanced non-small cell lung cancer are scheduled to start in the next few months.

Advanced hereditary medullary thyroid cancer, a rare malignancy, has a poor prognosis and there are currently very limited therapeutic options available. Medullary thyroid cancer is a specific form of thyroid cancer that comprises 2-3 per cent of the 25,000 new cases of the disease in the US each year. Neither standard chemotherapeutic regimens, nor radiation therapy, provide substantial benefits in patients with advanced hereditary medullary thyroid carcinoma.

Orphan-drug designation was designed to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions, specifically, those that affect less than 200,000 people in the US.

ZD6474 is the first oncology orphan-drug designation AstraZeneca has received. AstraZeneca has also applied for Orphan Drug designation for ZD6474 in medullary thyroid cancer in Europe.

Further enquiries to:

Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033

Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel + 1 212 579 0506