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28 March 2001
ASTRAZENECA MAKES FIRST REGULATORY SUBMISSION FOR USE OF 'CASODEX™' 150MG IN EARLY PROSTATE CANCER

AstraZeneca today submitted a dossier to the Medicines Control Agency, the UK regulatory authority, for the use of Casodex™ (bicalutamide) 150mg in the treatment of localised and locally advanced prostate cancer - Early Prostate Cancer (EPC). This is the first submission, two years earlier than the planned date, and will be followed by subsequent submissions around the world, with the objective of providing clinicians and patients with an additional treatment option for the early stages of prostate cancer.

This decision to submit a regulatory dossier was based on an analysis of the first results from the bicalutamide 150mg (Casodex) Early Prostate Cancer (EPC) Programme. Results from the Study 24, one the three studies forming part of Casodex™ (EPC) Programme, will be presented on Sunday, April 8, at the European Association of Urology meeting in Geneva, Switzerland.

With over 8,000 male patients in 23 countries* aged 38 to 93 years, the Casodex™ EPC Programme is the largest ever randomised clinical trial conducted in prostate cancer. It was set up to examine whether adding Casodex™ 150mg immediately to standard care (watchful waiting, radical prostatectomy or radiotherapy) could reduce the risk of disease progression and improve survival when compared to standard care alone.

Despite an increase in public awareness and screening, prostate cancer does not have the same level of public recognition as other forms of cancer, such as breast cancer. And yet it is the second most commonly diagnosed male cancer in many western countries, after lung cancer  [1].

Over 18,500 men, in the UK alone, are diagnosed with prostate cancer each year and this condition has overtaken cancer of the large bowel to become the second commonest cancer for men in the UK  [2].

In 2000, Casodex’s™ worldwide sales of $433m showed a 31 per cent increase compared to the previous year. Casodex™ is one of five important AstraZeneca products, whose growth is being fuelled by life cycle initiatives.

Further enquires to:

Media Relations

Chris Dalton
+44 (0) 1625 513010

Steve Brown
+44 (0)20 7304 5033

Lucy Williams
+44 (0)20 7304 5034


Investor Relations

Michael Olsson
+44 (0)20 7304 5087


Note to News Editors:

  • The bicalutamide 150mg (Casodex™) Early Prostate Cancer (EPC) Programme comprises three randomised, double-blind, placebo-controlled trials of similar design which are being conducted in distinct geographical areas (Study 023: Canada and USA Study 024: Europe, South Africa, Australia, Israel and Mexico, Study 025: Scandinavia). Men with localised and locally advanced prostate cancer (classed as T1b-4N0-1M0 (TNM 1997)) have been randomised on a 1:1 basis to receive bicalutamide 150mg (Casodex™) daily or placebo in addition to their standard care. Recruitment to the programme closed in July 1998, and follow-up is ongoing. Study endpoints include time to clinical progression, overall survival and tolerability. Patient age at enrolment ranged from 38 to 93 years (mean 67 years).
  • Bicalutamide (Casodex™) is a well-tolerated, once-daily, non-steroidal antiandrogen, currently used in treating the advanced stages of prostate cancer both as monotherapy (at the dose of 150 mg per day) and in conjunction with other hormonal treatments (at a dose of 50 mg per day).
  • Casodex™ is a Trademark, the property of the AstraZeneca group of companies.
  • 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 $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.


[1] Reis LA, Kosary CI, Hankey BF et al. SEER Cancer Statistics Review 1973-1996. Bethesda, National Cancer Institute, 1998

[2] Cancer research campaign, Scientific Year Book: 1998-1999



*USA, Canada, Australia, Austria, Belgium, Czech Republic, Eire, France, Germany, Holland, Hungary, Israel, Italy, Mexico, Poland, Portugal, South Africa, Spain, UK, Denmark, Finland, Norway, Sweden


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