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 formulation of TEMODAL can provide patients in the EU with an important alternative route of administration, and the sachet presentation can offer flexibility and a more convenient form of packaging," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "These two new options demonstrate Schering-Plough's commitment to providing effective treatments in a variety of presentations for specific patient needs and for patient convenience."
About temozolomideTEMODAL (temozolomide), a cytotoxic agent, is currently approved in oral form as 5mg, 20mg, 100mg, 140mg, 180mg and 250mg capsules in Europe. Cytotoxic agents are designed to impact the replication of cells that divide rapidly, such as those in tumors. TEMODAL was initially approved in the European Union (EU) in 1999 for the treatment of patients with malignant glioma, such as GBM or AA, showing recurrence or progression after standard therapy. In June 2005, TEMODAL received marketing approval in the EU for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy and subsequently as monotherapy treatment. The TEMODAL IV formulation reviewed by the CHMP was developed for cancer patients who are unable to take TEMODAL Capsules and has shown bioequivalence to the oral product. The sachet packaging presentation for TEMODAL Capsules was created to provide greater patient convenience and flexibility. Schering-Plough has received a Complete Response Letter from the U.S. Food and Drug Administration for the TEMODAR IV formulation and is working with the agency to address outstanding questions. TEMODAR capsules (temozolomide) received accelerated approval from the U.S. Food and Drug Administration (FDA) for adult patients with refractory AA in 1999 and full approval in March 2005 for refractory AA, ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine, and for the treatment of newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment. About Malignant Gliomas
The worldwide incidence rate of primary malignant brain and central nervous system tumors, using the world standard population, is 3.7 per 100,000 person in males and 2.6 per 100,000 person in females(1). The most common type of primary malignant brain tumors are gliomas, with AA and GBM being the most common and among the most serious types. Full prescribing information for TEMODAL can be found at http://www.emea.europa.eu/humandocs/Humans/EPAR/temodal/temodal.htm Full prescribing information for TEMODAR can be found at http://www.spfiles.com/pitemodar.pdf About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.