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| |  Nilandron, New Oral, Once-Daily Drug For Advanced Prostate Cancer KANSAS CITY, Mo., Sept. 20, 1996 -- Hoechst Marion Roussel today announced that Nilandron (nilutamide), a new oral, once-daily antiandrogen therapy for men with advanced prostate cancer, has been cleared by the Food and Drug Administration (FDA) for marketing in the United States. Indicated for use in combination with surgical castration (orchiectomy) for the treatment of advanced prostate cancer (cancer that has spread to other parts of the body), Nilandron will be launched in the United States in the fall of 1996. For maximum benefit, Nilandron must be started on the same day as or on the day after surgery. Currently, there is no cure for advanced prostate cancer, and hormonal therapy is used to control disease growth. Antiandrogens, which prevent the male hormone testosterone from promoting prostate cancer growth, are used in conjunction with either surgical removal of the testicles (the body's main source of testosterone production) or chemical castration, which involves the use of certain drugs to suppress testosterone production. In advanced prostate cancer, cancer cells have already spread to other parts of the body, usually the bones. Consequently, bone pain becomes a major complication of the disease. "Nilandron offers men with advanced prostate cancer a safe and effective new therapy that significantly reduces bone pain," said Peter Ladell, president, Hoechst Marion Roussel North America. "We are pleased to be able to provide this important new product that can help keep men active in the advanced stages of the disease." Prostate cancer is the most common type of cancer among American men and the second leading cause of cancer deaths among men. According to the American Cancer Society, one out of every five men will develop prostate cancer over the course of his lifetime. Approximately 317,000 new cases will be diagnosed in 1996. The disease is found mainly in men age 65 or older. Controlled clinical trials have demonstrated that patients receiving Nilandron immediately after surgical removal of the testicles experienced statistically significant improvement in bone pain (54 percent vs. 37 percent), longer progression-free survival (21.2 months vs. 14.7 months), and longer median overall survival time (27.3 months vs. 23.6 months) compared with patients receiving placebo. Nilandron patients also experienced a statistically significant benefit in complete or partial disease regression. In clinical studies, Nilandron was associated with a low incidence of diarrhea, with the most common adverse reactions being hot flushes, a delay in adaptation to dark (non-castration-related), nausea, constipation, and dizziness. Some of the frequently occurring adverse events are known to be associated with low androgen levels and occur with castration alone. Hoechst Marion Roussel is committed to patient-directed cancer care, and Nilandron represents the company's first U.S. product approval in a continuum of innovative cancer therapies aimed at enhancing the lives of cancer patients. A world leader in pharmaceutical-based health care, Hoechst Marion Roussel is dedicated to extending and enhancing human life through the discovery, development, manufacture and sale of pharmaceutical products. Hoechst Marion Roussel, with global headquarters in Frankfurt, Germany, and North American headquarters in Kansas City, Mo., is a member of the Hoechst Group.
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