FRAZER, Pa., Nov. 5 Cephalon, Inc. (Nasdaq: CEPH) today announced the journal Cancer has published a pivotal study demonstrating that TREANDA® (bendamustine HCl) for Injection induced durable responses in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had progressed during or within six months of treatment with rituximab. Results of this study, which supported the FDA approval of TREANDA in this patient population in October 2008, were published online yesterday and will also appear in the print edition at a later date. According to the National Cancer Institute, an estimated 30,000 people in the United States will be diagnosed this year with indolent NHL, a slow growing but serious cancer of the lymphatic system.
"The findings from this study confirm and expand upon previous investigations with bendamustine. Bendamustine provides physicians and patients with another valuable treatment option for recurring indolent B-cell NHL, a patient population that continues to grow," said Brad Kahl, M.D., Associate Professor, Director Lymphoma Service, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, and the lead investigator of this study.
In this multicenter, open-label, single-arm study, 100 patients received TREANDA intravenously at a dose of 120 mg per meter squared over 60 minutes on days one and two every 21 days for up to eight cycles. There were two primary endpoints in the study: the overall response rate (ORR) defined as the percentage of patients who responded to treatment, and the duration of response. In the published results, 75 percent of patients had a response to treatment with TREANDA, including 14 percent who had a complete response and three percent who had an unconfirmed complete response. The patient response to treatment lasted a median of 9.2 months. The most common adverse events in this study included myelosuppression, nausea, infection, fatigue, diarrhea, vomiting and fever; serious adverse events included febrile neutropenia and pneumonia.
TREANDA, a novel chemotherapy, was approved by the FDA for the treatment of chronic lymphocytic leukemia in March 2008. Efficacy relative to first line therapies other than chlorambucil has not been established. TREANDA received its second approval in October 2008 for the treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
The following serious adverse reactions have been associated with TREANDA in clinical trials: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions, and other malignancies.
TREANDA has a unique chemical structure that is synthesized to combine an alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of TREANDA remains unknown, TREANDA may act in two distinct ways to kill cancer cells. Preclinical studies suggest that TREANDA may lead to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe (a non-apoptotic pathway).
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, the Mundipharma Group of Independent Associated Companies. In Germany, bendamustine 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 select Asia Pacific Rim countries.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.
Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.
The company's proprietary products in the United States include: NUVIGIL® (armodafinil) Tablets [C-IV], TREANDA, AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride), PROVIGIL® (modafinil) Tablets [C-IV] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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