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Technology to Be Used to Study MGMT Methylation Status in Glioblastoma Multiforme Brain Cancer Patients Treated with TEMODAR(R) (Temozolomide) - Schering-Plough and ONCOMETHYLOME Sciences (OMS) Announce License and Collaboration Agreement For Use of OMS Pharmacogenomic Technology


Posted on: 11/16/2005

Technology to Be Used to Study MGMT Methylation Status in Glioblastoma Multiforme Brain Cancer Patients Treated with TEMODAR(R) (Temozolomide) - Schering-Plough and ONCOMETHYLOME Sciences (OMS) Announce License and Collaboration Agreement For Use of OMS Pharmacogenomic Technology



KENILWORTH, N.J. and DURHAM, N.C. and LIEGE, Belgium, Nov. 16 /PRNewswire- FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) and ONCOMETHYLOME Sciences, a privately held company, today announced a collaboration and license agreement for Schering-Plough to utilize assay technology from ONCOMETHYLOME Sciences that measures the methylation status of the MGMT gene in patients with glioblastoma multiforme (GBM), a form of malignant brain cancer, treated with temodar(R) (temozolomide). Under the collaboration, the DNA methylation status of the MGMT gene is being evaluated for its potential role in optimizing TEMODAR therapy in patients with GBM brain cancer.

"While the clinical benefit of TEMODAR is well established for the treatment of certain types of brain tumors, we hope these pharmacogenomic technologies will help to expand our understanding of how to optimize TEMODAR therapy and support efforts to achieve improved clinical outcomes for these patients," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, medical affairs, Schering-Plough Research Institute. Under the terms of the agreement, Schering-Plough receives a worldwide, non-exclusive license from ONCOMETHYLOME Sciences to use its pharmacogenomic assays and technology to evaluate methylation status of the MGMT gene in GBM patients treated with TEMODAR. The collaboration will initially focus on GBM brain cancer, with the possibility to expand the scope to other types of cancers and, potentially, other Schering-Plough products. ONCOMETHYLOME Sciences will receive an upfront license payment, milestone payments and sample processing fees from Schering-Plough. Additional financial terms of the agreement are not being disclosed.

"The collaboration with Schering-Plough offers the potential to enhance the applicability of established cancer drugs," said Herman Spolders, chief executive officer of ONCOMETHYLOME Sciences. "In addition, the agreement demonstrates the value of our patented technology in personalized medicine applications."

About GBM Brain Cancer

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. 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.

About ONCOMETHYLOME Sciences' MGMT Assay

The use of ONCOMETHYLOME Sciences' MGMT assay is based on the hypothesis that down- regulation of the MGMT gene may be a significant predictor of brain tumor response to treatment with alkylating agents like temozolomide. Methylation, which leads to down-regulation of the MGMT gene, has been reported to correlate with prolonged survival of glioblastoma multiforme patients who are treated with alkylating agents. The assay was initially developed by a team of Johns Hopkins University researchers in 2000 (N Engl J Med 2000; 343;1350-4) and was used in a retrospective analysis of a subset of patients in a study published in The New England Journal of Medicine in March 2005 (N Engl J Med 2005; 532; 997-1003).

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. In the United States, TEMODAR(R) (temozolomide) Capsules are approved for use in combination with radiotherapy, and then as maintenance for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer. In patients with refractory anaplastic astrocytoma (AA), another form of brain tumor, TEMODAR is indicated for use in adult patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. TEMODAR received accelerated approval for AA in 1999 and full approval for newly diagnosed GBM and recurrent glioma in March 2005.

In the European Union (EU), temolozomide (marketed in the EU under the trade name TEMODAL) was approved 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. 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 In Adult Patients 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.

About ONCOMETHYLOME Sciences

ONCOMETHYLOME Sciences is a leader in research, design and validation of molecular gene methylation tests for early cancer detection and personalized treatment decisions. Specifically, ONCOMETHYLOME products (1) detect cancer at an early stage of the disease and at a higher level of accuracy than currently available tests; (2) determine the aggressiveness profile of a patient's cancer; and (3) predict and monitor response to cancer therapy for optimal and more individualized treatment decisions.

ONCOMETHYLOME Sciences has a strong pipeline of patented diagnostic products, based on clinically validated cancer markers and the proven MSP technology, for major types of cancer. The Company collaborates with leading international molecular oncology research centers, such as The Johns Hopkins University, and has a number of commercial and collaborative partnerships with Veridex LLC, a Johnson & Johnson company; Cemicon International Inc.; EXACT Sciences Corp.; and Schering-Plough Corp. The offices of the Company are located in the Research Triangle Park area of Durham, NC, in Belgium, and in the Netherlands. For additional information, please visit http://www.ONCOMETHYLOME.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements, including statements relating to the company's strategy, the potential strategic benefit of the agreement and the market potential for TEMODAR. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details and a discussion of risks and uncertainties that may affect forward-looking statements, see the company's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.

About Schering-Plough

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., and its Web site is http://www.schering-plough.com.

Media Contacts: Denise K. Foy
Schering-Plough
(908)298-7616


Investor Contact: Alex Kelly
(908)298-7436
ONCOMETHYLOME Sciences
Contact: Lucija Turcinov
Phone: +32-479-801-902

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