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| |  Novantrone Approved by FDA for Prostate Cancer SEATTLE, Nov. 13, 1996-- Immunex Corporation (Nasdaq: IMNX) today announced the U.S. Food and Drug Administration has cleared for marketing the company's lead chemotherapy drug, Novantrone(R) (mitoxantrone) in combination with steroids, for treatment of patients with pain related to hormone refractory prostate cancer (HRPC). Immunex has established a toll free number (1-800-220-6302) to help patients and their families obtain the information they need about this new treatment. Novantrone is the first chemotherapy drug approved for advanced hormone refractory prostate cancer. "Novantrone's approval is an important advance because physicians have had very few options to effectively manage hormone resistant prostate cancer," said E. David Crawford, M.D., professor of urology at the University of Colorado. "Now we can offer patients a treatment that can reduce the pain of prostate cancer by working on the cancer itself." Nicholas Vogelzang, M.D., professor of medicine at the University of Chicago and chair of the prostate cancer committee of the Cancer and Leukemia Group B said, "Positive data from Novantrone studies are changing the way physicians are thinking about chemotherapy for treating late stage prostate cancer patients. Studies have shown that Novantrone is well tolerated and significantly decreases pain, so patients can continue to experience what's meaningful in their lives -- being with family and doing the things they enjoy most." Research studies have shown that Novantrone in combination with steroids will cause a significant reduction in pain and/or analgesic use in approximately 40 percent of patients and is generally well tolerated. In a pivotal study conducted by Dr. Ian Tannock and colleagues of the University of Toronto, patients were given either prednisone (a steroid) or prednisone plus Novantrone. More patients receiving Novantrone had a marked reduction in severe bone pain, which reduced their requirement for pain medications. Pain relief was four times longer for patients who responded to Novantrone (8 months vs. 2 months). About Hormone-Resistant Prostate Cancer The American Cancer Society estimates there will be 317,000 new cases of prostate cancer in the United States in 1996 and 41,400 deaths. A majority of patients who have advanced prostate cancer eventually progress to hormone-resistant disease. When hormones fail to keep late stage prostate cancer from progressing, the dominant symptom is often severe pain, which can be debilitating. Current supportive care includes analgesia (often narcotics, such as morphine), steroids or localized radiotherapy, but side effects can diminish patients' quality of life. About Novantrone Novantrone is a potent, well-tolerated anti-cancer agent, whose chemical structure is similar to other chemotherapy agents known as anthracyclines (e.g., doxorubicin and idarubicin), but lacks an amino sugar component that is thought to contribute to the cardiotoxicity characteristic of anthracyclines. Novantrone was first licensed in 1987 for use in acute myelogenous leukemia. A supplemental application submitted just six months ago, was given priority-review status by the FDA under the user-fee guidelines, meaning the FDA agreed to review the application within six months, compared to the normal 12-month review. In addition, the Novantrone application was one of the first filed with the FDA after President Clinton announced his initiative to speed cancer drug approvals for life threatening diseases for which there is no currently approved therapy. Immunex is a biopharmaceutical company dedicated to developing immune system science to protect human health. The company's products offer hope to patients with cancer, inflammatory and infectious disease. American Home Products owns a majority interest in Immunex. AHP is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, crop protection products, animal health care and medical devices.
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