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| |  European Drug Advisory Committee Recommends CAELYX For Advanced Ovarian Cancer MADISON, N.J. -- June 30, 2000 -- The European Union's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products has recommended approval of Schering-Plough Corporation's CAELYX® (pegylated liposomal doxorubicin hydrochloride) for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. The application for CAELYX proposes that it be administered intravenously once every four weeks for as long as the disease does not progress and the patient continues to tolerate treatment. The CPMP opinion serves as the basis for a European Commission approval, which is typically issued in approximately three months. Commission approval of the centralized Type II variation for CAELYX would result in unified labeling that would be immediately valid in all 15 EU-Member States. CAELYX has previously received centralized marketing authorization in the EU and is currently marketed for the treatment of AIDS-related Kaposi's sarcoma in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. CAELYX is a long-circulating Stealth® pegylated liposomal formulation of doxorubicin hydrochloride, a widely used cytotoxic agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors. Schering-Plough has exclusive international marketing rights to CAELYX, excluding Japan and Israel, through a distribution agreement with ALZA Corporation of Mountain View, CA, who markets the product in the United States under the tradename Doxil®. Ovarian cancer is the second most common gynecologic cancer and causes more deaths than any other cancer of the female reproductive system. Despite improvements in both response rates and survival with current combination chemotherapies, up to 30 percent of patients fail to respond to first-line therapy with platinum and paclitaxel. In addition, 55 percent to 75 percent of responding patients will relapse within two years. Because ovarian cancer has few early symptoms, most patients are not diagnosed until after their disease has progressed to an advanced stage, which contributes to the high mortality rate. Related link: Schering-Plough Corporation.
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