Michael Blash
Zeneca Pharmaceuticals
302-886-5465
[email protected]

Elizabeth Miller
InterScience
202-973-0374
[email protected]

Bob Schwadron
InterScience
212-468-3616
[email protected]

FOR IMMEDIATE RELEASE

NEW INVESTIGATIONAL STUDIES SHOW MONOTHERAPY WITH CASODEX OFFERS QUALITY-OF-LIFE BENEFIT OVER SURGICAL CASTRATION IN PATIENTS WITH ADVANCED PROSTATE CANCER
Other New Investigational Data at ASCO Suggest Survival Benefit for Hormonal Therapy From Zeneca in Patients With Minimal Disease

LOS ANGELES--May 19, 1998--New data on CASODEX(r)(bicalutamide) Tablets released here at the 34th Annual Meeting of the American Society of Clinical Oncology offer additional evidence of the medication's positive clinical benefits, both as monotherapy and in combination with a luteinizing hormone-releasing hormone analogue (LHRH-A), in the treatment of advanced prostate cancer. The potential benefits revealed in these studies further strengthen the clinical profile of CASODEX, which is already the most widely prescribed nonsteroidal antiandrogen hormonal therapy for the treatment of advanced prostate cancer in the United States.

Monotherapy With CASODEX May Improve Quality of Life in Patients With Advanced Disease

Already proven safe and effective for the treatment of advanced prostate cancer (stage D2) at 50 mg when used in combination with LHRH-A therapy (medical castration), a regimen called Combined Androgen Blockade or CAB, CASODEX is now under investigation for use as monotherapy dosed at one 150 mg tablet daily. Critical to the evaluation of CASODEX as monotherapy is its potential to improve patient well-being, which is the subject of two studies featured at the ASCO meeting.

The first of these investigational studies, "Improvements in Subjective Response in Patients with Advanced Prostate Cancer Treated with CASODEX Monotherapy Compared with Castration," by Dr. C.J. Tyrrell of Plymouth, England (Abstract #1214), examined subjective response data from two randomized trials involving 1,285 patients. Patient well-being was based on a variety of scoring mechanisms, including the ECOG performance status scale, level of cancer-related pain, and cancer-related analgesic requirements. Of the patients enrolled in the study, 288 patients with metastatic disease were symptomatic at the time they entered the trial, and, therefore, capable of demonstrating a response to therapy. "Of the metastatic patients we studied, 70 percent of those randomized to CASODEX(r)(bicalutamide) Tablets showed a favorable subjective response, as compared to 58 percent of patients with castration," said Dr. Tyrrell. "This finding was statistically significant (p =0.0460) and clinically relevant."

The second study, "Evaluation of Quality of Life of Prostate Cancer Patients During Up-Front Therapy With Either CASODEX Monotherapy or Goserelin Plus Flutamide," by Professor Alessandra Rubagotti and colleagues at the University and National Tumor Institute in Genoa, Italy (Abstract #1315), used data from a 30-item questionnaire that was administered to patients prior to treatment and at regular intervals during the first year of treatment. Patients were asked to respond to a variety of questions regarding the effect of the disease (and subsequent treatment) on daily activities, fatigue, pain, sexual functioning (interest, enjoyment and erection), psychological distress, and interference with social life.

A preliminary evaluation of 18 preselected questions answered by 130 patients suggest that at both three- and six-month intervals, patients receiving CASODEX demonstrated better quality of life than patients receiving the CAB regimen, specifically in the areas of anxiety, depression, and sexual functioning.

"When examining the benefits of prostate cancer therapy, we must always remember that we are treating people--not just a disease," said Prof. Rubagotti. "Assuming that a specific therapy is efficacious, other nonclinical factors--such as convenience through once-daily dosing and oral administration, as well as reduced negative effects on quality of life--should also be considered."

CASODEX(r)(bicalutamide) Tablets and Survival: New Data From a Pivotal Trial

The third study with CASODEX featured at ASCO this year, "Bicalutamide Plus Luteinizing Hormone-Releasing Hormone Analogue (LHRH-A) Versus Flutamide Plus LHRH-A in Patients with Stage D2 Prostate Cancer: Clinical Outcome by Extent of Disease Assessed by Bone Scan," by Dr. M.S. Soloway of the University of Miami School of Medicine and associates (Abstract #1325), used data from one of the largest advanced prostate cancer research studies ever conducted--a double-blind, randomized clinical trial involving 813 patients. Minimal disease was defined as less than 5 lesions and extensive disease as greater than 6 lesions.

An exploratory analysis using time to progression (TTP) and survival as endpoints suggests that among patients with minimal disease, those treated with CASODEX plus LHRH-A demonstrated improved outcome for survival after a median follow-up period of 160 weeks. TTP outcome in these patients was similar with either regimen, however. Among patients with extensive disease, both TTP and survival were similar with either treatment regimen.

CASODEX and Prostate Cancer

According to the American Cancer Society, more than 189,500 American men will be diagnosed with prostate cancer in 1998, with 39,200 deaths resulting from the disease. Prostate cancer is the most frequently diagnosed of all malignancies in men--other than certain skin cancers--and is second only to lung cancer as a cause of cancer-related deaths in men.

Developed, manufactured, and marketed by Zeneca Pharmaceuticals, CASODEX(r)(bicalutamide) Tablets was approved by the Food and Drug Administration in October 1995 for use in combination therapy with an LHRH-A such as ZOLADEX for treatment of advanced metastatic prostate cancer (stage D2). In 1997, CASODEX became the most widely prescribed antiandrogen in the United States. CASODEX 50 mg in combination with an LHRH-A is generally well-tolerated. The most commonly reported adverse events with CASODEX plus LHRH-A are hot flashes, pain, constipation, back pain, pelvic pain, nausea, diarrhea, and infection.

Zeneca Pharmaceuticals is a business unit of Zeneca Inc., based in Wilmington, Del. In the United States, Zeneca Inc. is a $3.4 billion bioscience business with approximately 7,500 employees. Zeneca Inc. is a wholly-owned subsidiary of the U.K.-based Zeneca Group PLC (NYSE:ZEN), a major $8.6 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services.

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NOTE: For full prescribing information for CASODEX(r) (bicalutamide) Tablets and ZOLADEX(r) (goserelin acetate implant), please call 1-800-456-3669, ext. 2231, or access the World Wide Web at www.prostateinfo.com.