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NDA Submitted for Bendamustine in B-cell Non-Hodgkin's Lymphoma

FRAZER, Pa., Dec. 31 /PRNewswire-FirstCall/ -- Cephalon, Inc. (NASDAQ:CEPH) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Treanda (bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen. According to the National Cancer Institute, an estimated 30,000 people in the United States will be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment.

"Treanda is the lead product in our oncology pipeline and with this second NDA submission for the product in 2007 we have achieved a significant milestone for our business," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "The clinical data supporting this submission highlight the potential of Treanda to make a meaningful difference for patients with indolent NHL who have relapsed during or following treatment with rituximab."

The Treanda NDA for relapsed indolent NHL is supported by three studies in patients with NHL, including one in combination with rituximab. In these studies, patients treated with Treanda had a high rate of response and a manageable and tolerable side effect profile, with adverse events similar to those observed with other chemotherapy agents.

About Treanda

Treanda is a novel chemotherapeutic agent, a hybrid of a purine analog and an alkylator. Preclinical data demonstrate that Treanda acts in two distinct ways to kill cancer cells. Treanda damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The contribution of the purine analog to the antitumor effect of Treanda is under investigation but has not yet been determined.

The protocol for the Treanda NHL pivotal trial received special protocol assessment (SPA) approval from the 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 September 2007, Cephalon submitted an NDA requesting approval of Treanda for the treatment of patients with chronic lymphocytic leukemia (CLL), for which the FDA has granted priority review and orphan drug status.

Source: Cephalon

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