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Schering-Plough Reports FDA Grants Priority Review to TEMODAR(R) (Temozolomide) Supplemental New Drug Application for Gliomas (Brain Tumors)

Posted on: Friday, 29 October 2004, 09:00 CDT

KENILWORTH, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today reported that the U.S. Food and Drug Administration (FDA) has granted six-month priority review status to its supplemental New Drug Application (sNDA) for TEMODAR(R) (temozolomide) Capsules for the treatment of gliomas, a form of brain tumor. The application was submitted to FDA in September 2004.

Priority review status is granted to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments.

Schering-Plough is seeking marketing approval for the use of TEMODAR for the treatment of patients with newly diagnosed high grade gliomas concomitantly with radiotherapy and then as adjuvant treatment after the patient has completed radiotherapy.

The supplement provides clinical support for the potential use of TEMODAR in this first-line indication based on efficacy and safety data from a recently completed Phase III study conducted by the EORTC(1) in patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant glioma. Based on this data and supported by earlier clinical studies, the sNDA also seeks to broaden the current indication for TEMODAR to include the treatment of patients with recurrent and refractory high grade gliomas.

Schering-Plough also noted that FDA has granted orphan-drug designation to TEMODAR (temozolomide) for the treatment of newly diagnosed high grade gliomas.

TEMODAR is currently indicated and marketed in the United States for the treatment of adult patients with refractory anaplastic astrocytoma, a form of brain tumor.

Schering-Plough has filed a similar supplemental new drug application with the European Medicines Agency (EMEA). In the European Union, temozolomide is marketed as TEMODAL(R) and is currently indicated for the treatment of patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

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 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/.

Reference:

(1) 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; Tübingen, Germany,

Toronto, ON, Canada; Rotterdam, The Netherlands; Brussels Belgium;

London, ON, Canada.

Schering-Plough Corporation

CONTACT: Media - Robert J. Consalvo, +1-908-298-7409, Investors - AlexKelly, +1-908-298-7450, Janet M. Barth, +1-908-298-7417, all of Schering-Plough Corporation

Web site: http://www.schering-plough.com/

Company News On-Call: http://www.prnewswire.com/comp/777050.html

Source: PRNewswire-FirstCall

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