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TREANDA Significantly Improves Clinical Outcomes in Patients with Chronic Lymphocytic Leukemia Compared to Chlorambucil
Date:12/10/2007

of patients with CLL and Cephalon expects a review decision from FDA by the end of March 2008. FDA granted orphan drug status for TREANDA for CLL in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity for this indication in the United States, if the product is approved.

TREANDA is also being studied for the treatment of patients with indolent non-Hodgkin's lymphoma (NHL) whose disease has progressed during or following treatment with rituximab. The detailed results of this Phase 3 study also were presented during the ASH annual meeting. In addition, Cephalon has studied TREANDA in combination with rituximab in patients with relapsed indolent and mantle cell NHL. Cephalon plans to submit an NDA for TREANDA by the end of 2007 as a single agent for the treatment of patients with indolent NHL whose disease has progressed during or following treatment with rituximab.

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma 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 develop and market bendamustine HCl in Japan and selected Asian countries.

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 includes a number of promising investigational and marketed compounds. In addition to TREANDA, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX(R) (arsenic trioxide) injection, a product approved in the United Sta
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SOURCE Cephalon, Inc.
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