AstraZeneca files application for Casodex
ASTRAZENECA FILES SUPPLEMENTAL NEW DRUG APPLICATION WITH FDA FOR CASODEX 150MG MONOTHERAPY FOR THE TREATMENT OF PROSTATE CANCER AstraZeneca today announced that a supplemental new drug application (sNDA) has been filed with the US Food and Drug Administration (FDA) for Casodex 150mg monotherapy for the treatment of locally advanced, non- metastatic prostate cancer. Data from two clinical studies submitted for FDA review show that Casodex 150mg is the first anti-androgen as monotherapy to offer men a more acceptable alternative to the currently available options of surgical or medical castration, both of which have significant quality of life issues. Quality of life data indicate there are significant improvements in maintenance of sexual interest and in physical capacity in comparison with those patients who had castration, making Casodex 150mg monotherapy a suitable treatment for men with earlier stage disease. "In the US, a man is diagnosed with prostate cancer every three minutes. This potential new indication for Casodex will strengthen the profile of a medicine already proven to be a valuable treatment option for patients with advanced prostate cancer," said Dr George Blackledge, Vice President, Medical Director of Oncology. Casodex as a 50mg once-daily tablet was first introduced in 1995 as a treatment for advanced prostate cancer in combination with an LHRH analogue or surgical castration. Casodex 150mg monotherapy has already been approved by the regulatory authorities in several countries including the UK and Sweden and further approvals are expected in 2000. Casodex is the world's leading brand of anti-androgen. It is now available in over 70 markets worldwide with sales in 1999 of $340 million. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (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 $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. 28 February 2000 FURTHER ENQUIRIES: Media enquiries: Steve Brown (London) (020) 7304 5033 Lucy Williams (London) (020) 7304 3034 Analyst/investor enquiries Elizabeth Sutton (020) 7304 5101 Michael Olsson (020) 7304 5087 Ed Seage (Wilmington) (302) 886 4065 Jorgen Winroth (Wayne) (609) 896 4148 ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/02/28/20000228BIT00250/bit0001.doc http://www.bit.se/bitonline/2000/02/28/20000228BIT00250/bit0002.pdf