TREANDA Demonstrates Substantial Efficacy in Patients with Relapsed Indolent Non-Hodgkin'...(l for the NHL pivotal trial presented at...),Health

Date:12/10/2007

l for the NHL pivotal trial presented at ASH received special protocol assessment (SPA) approval from the U.S. Food and Drug Administration (FDA) in February 2006. The SPA process allows for FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and/or data analysis. In addition, Cephalon has completed a phase 2 study with TREANDA in combination with rituximab in patients with relapsed indolent and mantle cell NHL. Cephalon plans to submit a new drug application (NDA) for TREANDA by the end of 2007 for the treatment of patients with indolent NHL whose disease has progressed during or following treatment with rituximab.

In September 2007, Cephalon submitted an NDA requesting approval of TREANDA for the treatment of patients with CLL, for which the FDA has granted orphan drug status. The pivotal study data included in the NDA submission are also being presented at ASH.

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 t
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SOURCE Cephalon Inc. Copyright©2007 PR Newswire. All rights reserved

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