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Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
Date:9/21/2007

ngoing study, the company anticipates filing an NDA for TREANDA in patients with indolent NHL who are refractory to rituximab in the fourth quarter of 2007. In addition, Cephalon is studying TREANDA in combination with rituximab in patients with relapsed indolent and mantle cell NHL. The company anticipates that results from studies of TREANDA as monotherapy and in combination will be presented at medical meetings later this year.

Upon FDA acceptance of the company's NDA filing of TREANDA for CLL, the company will make a $15 million milestone payment to former shareholders of Salmedix.

About TREANDA

TREANDA is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that TREANDA induces rapid, sustained single- and double-strand DNA damage, which results in apoptosis, or programmed cell death, in the tumor. TREANDA also induces mitotic checkpoint inhibition, which results in non-apoptotic cell death. TREANDA causes DNA disruption that is both extensive and durable exhibiting a low level of cross-resistance to other cytotoxic agents. The dual-effect of the anti-tumor activity of TREANDA may be attributable to its unique chemical design.

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Deutschland GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN(R). In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to market and sell bendamustine HCl in Asia.

About Cephalon Oncology

Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients and healthcare providers. The Cephalon Oncology portfolio
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SOURCE Cephalon, Inc.
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