CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Br...( Schering-Plough Receives CHMP Positiv...),Health

Schering-Plough Receives CHMP Positive Opinion for TEMODAL(R) Intravenous Formulation and Oral TEMODAL Sachet Presentation -- Providing Potential New Treatment Options for EU Patients with Certain Primary Brain Tumors

KENILWORTH, N.J., Dec. 8 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of the intravenous (IV) formulation of TEMODAL(R) (temozolomide) as an alternative to the already approved oral form of temozolomide in the EU. The CHMP also has issued a positive opinion recommending approval of a sachet packaging presentation for TEMODAL Capsules. This new presentation was created to provide greater patient convenience and flexibility.

TEMODAL Capsules are a chemotherapy agent approved in the EU for treatment of patients with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy, and for patients with malignant gliomas, such as GBM or anaplastic astrocytoma (AA), showing recurrence or progression after standard therapy. The CHMP recommendation serves as the basis for a European Commission approval of the IV formulation of TEMODAL and the sachet presentation of TEMODAL Capsules. In the US, temozolomide, marketed as TEMODAR(R) Capsules, is approved for the treatment of adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment, as well as for refractory AA, ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

"TEMODAL is a well recognized, effective treatment for patients in Europe with malignant gliomas, but is only available orally. Upon approval, the IV f
'/>"/>