Schering-Plough Submits Centralized Type II Variation in EU
for TEMODAL(R) as Treatment for Brain Tumors, Malignant Melanoma
MADISON, N.J., March 30 /PRNewswire/ via NewsEdge Corporation -- Schering-Plough Corporation (NYSE: SGP) today announced that it has submitted a centralized Type II variation to the European Union's (EU) European Medicines Evaluation Agency (EMEA) seeking clearance to market TEMODAL(R) (temozolomide) Capsules for the treatment of patients with anaplastic astrocytoma (a type of brain cancer) showing recurrence or progression after standard therapy, and as first-line treatment of patients with advanced metastatic melanoma.
Approval of the centralized Type II variation for TEMODAL would result in unified labeling that would be immediately valid in all 15 European Union- Member States. In January, the EU's Commission of the European Communities granted centralized marketing authorization to TEMODAL for the treatment of patients with glioblastoma multiforme (another type of brain cancer) showing recurrence or progression after standard therapy.
TEMODAL is an oral cytotoxic chemotherapeutic agent with demonstrated antitumor activity. Schering-Plough has exclusive worldwide rights to market temozolomide through a licensing agreement with Cancer Research Campaign Technology, Ltd., of the United Kingdom.
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.
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
/CONTACT: Media: Robert J. Consalvo, 973-822-7409, Investors: Geraldine U. Foster, 973-822-7410, Lisa W. DeBerardine, 973-822-7437, or Janet M. Barth, 973-822-7417, all of Schering-Plough/ /Web site: www.schering-plough.com/ (SGP)