KENILWORTH, N.J., Nov. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that Schering-Plough K.K., the company’s country operation in Japan, has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval of TEMODAL (R) (temozolomide) Capsules for the treatment of malignant glioma. The MHLW has agreed to conduct a priority review of the J-NDA, to satisfy an unmet medical need in Japanese patients.
Malignant gliomas are primary brain tumors that develop from glial cells. Approximately 30 percent of primary brain tumors are gliomas, which affect approximately six to eight people per 100,000 people worldwide. Both glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are types of gliomas. GBM is the most common and aggressive form of primary brain tumor.
“TEMODAL is an important treatment advance for this devastating disease and we look forward to working with the MHLW to assure that patients throughout Japan will have access to this therapy,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
The J-NDA for TEMODAL is based on efficacy and safety data from six studies including a study of 32 Japanese patients with recurrent AA and a Phase III study conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC). The Phase III study, described in a publication in the March 10, 2005 edition of the New England Journal of Medicine, involved 573 patients with newly diagnosed GBM and demonstrated longer survival in the patients who received TEMODAL and radiation compared with those who received only radiation.
About Temozolomide
Temozolomide is an oral, cytotoxic alkylating agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including 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 anaplastic astrocytoma, 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. Schering-Plough received accelerated approval in the US for relapsed refractory AA in 1999 and full approval of temozolomide (TEMODAR) from the U.S. Food and Drug Administration (FDA) in March 2005 for relapsed refractory AA and for the treatment of newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment. The development of temozolomide for additional markets and expanded indications is consistent with Schering-Plough’s strategy to broaden its oncology portfolio and is in line with its plans to build strength in its global franchises through both internal research and external collaborations and licensing opportunities.
Important Information Regarding U.S. Labeling for TEMODAR with Newly Diagnosed GBM
Patients treated with TEMODAR Capsules may experience myelosuppression. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. TEMODAR Capsules are contraindicated in patients who have a history of hypersensitivity to any of its components, or to dacarbazine (DTIC). Caution should be exercised when administered to those with severe hepatic or renal impairment. TEMODAR may cause fetal harm when administered to a pregnant woman. Nursing should be discontinued in women receiving TEMODAR. The effectiveness of TEMODAR in children has not been established. TEMODAR Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. Prophylaxis against Pneumocystis carinii pneumonia (PCP) is required in all patients receiving TEMODAR in combination with radiotherapy for the 42-day regimen with or without RT. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. All patients receiving TEMODAR, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen. As noted in the U.S. package insert, during the concomitant phase (TEMODAR + radiotherapy), adverse events including thrombocytopenia, nausea, vomiting, loss of appetite and constipation, were more frequent in the TEMODAR + radiotherapy arm versus the radiotherapy arm alone. The incidence of other adverse events was comparable in the two arms. The most common adverse events across the cumulative TEMODAR experience were hair loss, nausea, vomiting, decrease in appetite, headache and constipation.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company’s Web site is www.scheringplough.com. Schering- Plough K.K., based in Osaka, is a country operation of Schering-Plough.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including the market for drugs to treat GBM and AA and the company’s strategy. Forward-looking statements relate to expectations or forecasts of future events. Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough’s business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering- Plough’s forward-looking statements. These factors include uncertainties in the regulatory process, market acceptance of TEMODAL, manufacturing issues, current and future branded and generic competition, timing of trade buying, and difficulties in product development. For further details about these and other factors that may impact the forward-looking statements, see Schering- Plough’s Securities and Exchange Commission filings, including the company’s second quarter 2005 10-Q.
Schering-Plough Corporation
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