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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
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