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| |  Nilandron for Prostate Cancer Now Available in the U.S. KANSAS CITY, Mo., Nov. 6, 1996 -- Hoechst Marion Roussel, the pharmaceutical division of Hoechst AG, today announced that Nilandron(TM) (nilutamide), a new, affordable, once-a-day, nonsteroidal antiandrogen for the treatment of advanced prostate cancer, is now available in the United States. Nilandron, which was cleared for marketing in mid-1996, significantly reduces bone pain and lengthens time to disease progression. Nilandron is indicated for use in combination with orchiectomy for the treatment of advanced prostate cancer (cancer that has spread to other parts of the body). For maximum benefit, Nilandron should be initiated on the same day as or on the day after surgery. Prostate cancer is the most common type of cancer and the second leading cause of cancer deaths among American men. According to the American Cancer Society, one out of every five American men will develop prostate cancer over the course of his lifetime. The risk of developing prostate cancer increases with age. More than 80 percent of all prostate cancers are diagnosed in men older than 65. 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 (orchiectomy) or administration of a luteinizing hormone-releasing hormone (LHRH) analog (medical castration) to stop testosterone production. "Nilandron offers men with advanced prostate cancer a safe and effective new therapy that significantly alleviates bone pain and slows cancer growth," said Peter Ladell, president, Hoechst Marion Roussel North America. "We have priced Nilandron at an affordable level that offers a significant economic benefit to the patient." Hoechst Marion Roussel will also provide physicians with 90-count sample boxes. "This sample program is designed to help reduce the financial burden of treatment, an important consideration for older patients living on limited or fixed incomes," Ladell added. Clinical Trials 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. Nilandron was generally well tolerated 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. Nilandron will be available by prescription as 50-mg tablets for oral administration. The recommended starting dose is 300 mg once a day for 30 days followed by a total daily dosage of 150 mg. "The availability of Nilandron in the United States demonstrates Hoechst Marion Roussel's commitment to enhancing lives through oncology innovations. Oncology is an important growth area for our company and Nilandron represents our first product introduction in this category," Ladell added. Hoechst Marion Roussel, a world leader in pharmaceutical-based health care, 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, is a member of the Hoechst Group. Hoechst Marion Roussel North America is headquartered in Kansas City, Mo.
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