Schering-Plough Submits NDA for Temodal(R) as Treatment for Brain Tumors, Malignant Melanoma

MADISON, N.J., Aug. 18 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking marketing clearance for TEMODAL(R) (temozolomide) Capsules for the treatment of adult patients with malignant glioma (glioblastoma multiforme and anaplastic astrocytoma) at first relapse and as first-line treatment for patients with advanced metastatic malignant melanoma. The company has requested priority review status for the NDA.

TEMODAL, an oral cytotoxic, alkylating agent, is the lead compound in a new class of compounds known as imidazotetrazines. Schering-Plough has exclusive worldwide rights to market temozolomide through a licensing agreement with Cancer Research Campaign Technology, Ltd., of the United Kingdom.

Schering-Plough in January submitted a centralized Marketing Authorization Application for TEMODAL to the European Union's (EU) European Medicines Evaluation Agency (EMEA) seeking marketing clearance for the treatment of patients with recurrent malignant gliomas. EMEA approval of the centralized Marketing Authorization for TEMODAL would result in unified labeling that would be valid in all 15 EU-member states.

Malignant gliomas, such as glioblastoma multiforme and anaplastic astrocytoma, are among the most serious and aggressive types of malignant brain tumors, with median patient survival times ranging from nine to 12 months from initial diagnosis. Despite intensive treatment with surgery, radiotherapy and chemotherapy, patients with malignant glioma almost invariably experience tumor recurrence. Median survival in patients with recurrent high-grade glioma ranges from only three to six months from the time of recurrence.

Glioblastoma multiforme is a rapidly growing cancer of the central nervous system, most often located in the cerebrum. It is the most common and deadliest type of primary brain tumor. Anaplastic astrocytoma is the second most common type of brain tumor.

Malignant melanoma is the most serious and life-threatening form of skin cancer, accounting for only about 5 percent of skin cancers but causing approximately 75 to 85 percent of skin-cancer-related deaths. Patients with Stage IV (disseminated malignant) melanoma generally have a very poor prognosis. Median survival for Stage IV patients ranges from four to eight months, with five-year survival being rare.

Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.

  SOURCE  Schering-Plough Corporation       -0-                             08/18/98   

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      /Web site:  http://www.schering-plough.com/     (SGP)  CO:  Schering-Plough Corporation ST:  New Jersey IN:  MTC SU:  DY -- NYTU021 -- 7458 08/18/98 08:24 EDT http://www.prnewswire.com