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TEMODAL(R) Approved in European Union For Treatment of Newly Diagnosed Glioblastoma Multiforme


Posted on: 06/10/2005

TEMODAL(R) Approved in European Union For Treatment of Newly Diagnosed Glioblastoma Multiforme

Most Common and Aggressive Form of Brain Cancer

KENILWORTH, N.J., June 10 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission has granted approval of TEMODAL(R) (temozolomide) Capsules for first-line use for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM), the most common and aggressive form of primary brain cancer. The approval follows a positive opinion granted on April 21, 2005, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

The approval of TEMODAL in combination with radiotherapy followed by up to six cycles of TEMODAL monotherapy is valid in the current 25 EU Member States as well as in Iceland and Norway. The approval is based largely on efficacy and safety data from the landmark Phase III study conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC) Clinical Trial Group.

These data were published in the March 10, 2005, edition of the New England Journal of Medicine. In this multicenter trial of 573 patients with newly diagnosed GBM, significant improvement in overall survival was observed in patients who were treated with TEMODAL in combination with radiotherapy compared with those treated with radiotherapy alone.

"Newly diagnosed GBM patients and their physicians now have an opportunity to combat this most aggressive brain tumor in its early stages. As demonstrated in our clinical trial, TEMODAL provides a significant improvement in survival compared to standard therapy," said Roger Stupp, M.D., University Hospital Multidisciplinary Oncology Centre in Lausanne, Switzerland and lead investigator of the EORTC/NCIC trial.

"It is important for patients throughout the EU to have access to this important treatment advance for this devastating disease," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.

The study results showed that 26 percent of the patients in the TEMODAL group will survive two years or longer, as compared to 10 percent for those who received radiotherapy alone, doubling the survival rate at two years. Median survival in the TEMODAL group was also significantly better (14.6 vs. 12.1 months) compared to the radiotherapy only group. TEMODAL treatment was generally well tolerated; the most commonly observed adverse events (greater than 10%) in patients receiving TEMODAL in combination with radiotherapy followed by TEMODAL monotherapy included decreased appetite, headache, constipation, nausea, vomiting, hair loss, rash, convulsions, fatigue, diarrhea, stomatitis and blurred vision. Low white blood cells and low platelets, which are known dose-limiting toxicities for most cytotoxic agents, including TEMODAL, were observed. When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8 percent of the patients. Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 percent of the patients who received TEMODAL.

About Gliomas

Glioblastoma multiforme (GBM) is a rapidly growing neuroglia cell tumor of the central nervous system, most often located in the cerebrum. It is the most common and deadliest type of primary brain tumor. GBM is more common among males and occurs more frequently in Caucasians. The median age at which people are diagnosed with GBM is 50 to 60 years. In Europe, an estimated 10,000 patients are diagnosed with glioblastoma multiforme each year in EU member countries.

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. The development of temozolomide for 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.

TEMODAL was first approved in the EU in 1999 for the treatment of patients with glioblastoma multiforme, showing recurrence or progression after standard therapy. TEMODAL was subsequently approved for the treatment of patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Schering-Plough received full approval of temozolomide (TEMODAR(R)) from the U.S. Food and Drug Administration (FDA) in March 2005 for the treatment of adult patients with newly diagnosed GBM when administered in combination with radiotherapy and then as maintenance therapy.

Important Information Regarding U.S. Labeling for TEMODAR with Newly Diagnosed GBM

Patients treated with TEMODAR Capsules may experience myelosuppression. Grade 3/4 neutropenia occurred in 8 percent and Grade 3/4 thrombocytopenia in 14 percent of patients treated with temozolomide. 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 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. 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 plus radiotherapy), adverse events including thrombocytopenia, nausea, vomiting, loss of appetite and constipation, were more frequent in the TEMODAR plus radiotherapy arm versus the radiotherapy arm alone. The incidence of other adverse events were 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 http://www.schering-plough.com.

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 the company's strategy. Forward-looking statements relate to expectations or forecasts of future events and use words such as "estimated" and "plans." 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 first quarter 2005 10-Q.

NOTE TO EDITORS: Schering-Plough press releases are available on the company's Web site at http://www.schering-plough.com Schering-Plough press releases are also available on PRNewswire's Web site at http://www.prnewswire.com/comp/777050.html



SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com Company News On Call: Company News On-Call: http://www.prnewswire.com/comp/777050.html


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