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Schering-Plough Corporation (SGP) Release: FDA Approves TEMODAR(R) (temozolomide) As Treatment For Patients With Newly Diagnosed Glioblastoma Multiforme


10/19/2005 5:13:02 PM

KENILWORTH, N.J., March 16 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today reported that the U.S. Food and Drug Administration (FDA) has granted approval for TEMODAR(R) (temozolomide) Capsules for use in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer. The approval was based on data that demonstrated a significant overall survival benefit in patients who were treated with TEMODAR in combination with radiotherapy. Concurrent with the approval for newly diagnosed GBM, TEMODAR also received full approval for the treatment of adult patients with refractory anaplastic astrocytoma (AA), another form of brain tumor. TEMODAR received accelerated approval for AA in 1999 and is currently marketed for this indication in the United States.

"TEMODAR represents an important component for patients and physicians in the fight against GBM and validates the real benefits of chemotherapy in treating this disease," said Dr. Henry Friedman, co-director, Clinical Neuro-Oncology Program, The Brain Tumor Center at Duke. "After 26 years of practicing neuro-oncology, I view TEMODAR as a significant advancement in battling GBM."

The full approval of TEMODAR follows a priority review of the supplemental new drug application containing the GBM data that was submitted in September 2004. FDA grants priority review status to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments.

"We are very pleased with today's FDA action and what it means for patients with GBM, the most serious and aggressive type of malignant brain tumor," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "This approval represents a significant advance in the treatment of brain cancer, a disease for which few effective treatments exist."

The approval of TEMODAR for newly diagnosed GBM was based on efficacy and safety data from a landmark Phase III study conducted by the European Organisation for Research and Treatment of Cancer (EORTC)(1) in patients with newly diagnosed GBM. These data were published in the March 10, 2005 edition of the New England Journal of Medicine.(2) In this multicenter trial of 573 patients, significant improvements in overall survival were observed in patients who were treated with TEMODAR in combination with radiotherapy. Myelosuppression was the dose-limiting adverse event. The most common adverse events across the cumulative TEMODAR experience were alopecia, nausea, vomiting, anorexia, headache, and constipation. Forty-nine percent of patients treated with TEMODAR reported one or more severe or life-threatening events, most commonly fatigue (13%), convulsions (6%), headache (5%) and thrombocytopenia (5%). There may be a higher occurrence of opportunistic infections such as pneumocystis carinii pneumonia (PCP) when TEMODAR is administered during a longer dosing regimen. However, all patients receiving TEMODAR, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen.

Under the full approval, TEMODAR is now indicated for use in adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment after the patient has completed radiotherapy. In patients with refractory AA, TEMODAR is indicated for use in adult patients who have experienced disease progression on a drug regimen containing nitrosurea and procarbazine.

Schering-Plough has filed an application with the European Medicines Agency (EMEA) seeking approval of a similar indication for first-line GBM. In the European Union, temozolomide is marketed as TEMODAL(R) and is currently indicated for the treatment of patients with malignant glioma, such as GBM or AA, showing recurrence or progression after standard therapy.

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. Schering-Plough currently markets temozolomide in 75 countries, with global sales reaching $459 million in 2004. For full prescribing information, please visit: http://www.spfiles.com/pitemodar.pdf

About Gliomas

Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are high-grade gliomas (brain tumors). 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. It is the third leading cause of cancer-related death in young adults age 20 to 29. The median age at which people are diagnosed with GBM is 50 to 60 years. The annual incidence of GBM is four to five cases per 100,000 persons, with 8,000 to 10,000 new cases diagnosed per year in North America.

Anaplastic astrocytoma (AA) is the second most common type of brain tumor and can progress to become GBM. It is a particularly aggressive tumor with few treatments available. The median age at which people are diagnosed with AA is 40 to 50 years. The annual incidence of AA is one to 1.5 cases per 100,000 persons, with 2,000 to 3,000 new cases diagnosed per year in North America.

Schering-Plough 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 is based in Kenilworth, N.J., USA, and its 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 company's strategy and the market for drugs to treat GBM and AA. Forward-looking statements relate to expectations or forecasts of future events and use words such as "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 the regulatory process for new products and new indications, market acceptance of new products and new indications, manufacturing issues, current and future branded, generic and over-the-counter competition, timing of trade buying, and matters impacting patents on Schering-Plough products. 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 2004 annual report on Form 10-K.

References: (1) T. Stupp, NEJM Concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) for newly diagnosed glioblastoma multiforme (GBM). Conclusive results of a randomized phase III trial by the EORTC Brain & RT Groups and NCIC Clinical Trials Group. R. Stupp, NCIC1, M. Weller, M van den Bent, NCIC2, M. Taphoorn, NCIC3, EORTC Vienna/Regensburg or Padova, D. Lacombs, R.O. Mirimanoff for the European Organization for Research and Treatment of Cancer Brain Tumor & Radiotherapy Groups and National Cancer Institute Canada; Lausanne, Switzerland; Tubingen, Germany, Toronto, ON, Canada; Rotterdam, The Netherlands; Brussels Belgium; London, ON, Canada. (2) Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma. R. Stupp et al for the European Organization for Research and Treatment of Cancer Brain Tumor & Radiotherapy Groups and National Cancer Institute of Canada Clinical Trial Groups. NEJM. 2005, 352 (10): 987-996 March 10, 2005.

Schering-Plough Corporation

CONTACT: Media: Joy Schmitt, +1-908-298-3944, or Investors: Alex Kelly,+1-908-298-7450, or Janet M. Barth, +1-908-298-7417, all of Schering-PloughCorporation


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