Final Data from Pivotal Study Presented at 49th American Society of
FRAZER, Pa., Dec. 10 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that in a pivotal study of patients with indolent non-Hodgkin's lymphoma (NHL), whose disease has progressed during or following treatment with rituximab, TREANDA (bendamustine HCl) induced a high rate of response. TREANDA(R) is a novel investigational chemotherapy. 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. The final data from this multicenter study were presented at the 49th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA [Poster # 505-I; Abstract #1351].
"The high response rate in this study suggest that bendamustine could offer substantial periods of remission to patients with indolent NHL whose cancer is progressing after treatment with rituximab," said Brad Kahl, MD, Associate Professor, Director Lymphoma Service, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, and the lead investigator of this study. "Because many patients with NHL eventually become resistant to treatment with rituximab and other therapies, new treatments are always required."
In this pivotal study of 100 patients with indolent NHL whose disease has progressed during or following treatment with rituximab, or a rituximab- containing regimen, as assessed by an independent radiological committee, 75 patients had a response. Of those patients who responded to treatment, 14 had a complete response and three had an unconfirmed complete response. The median duration of response was 9.2 months. Bendamustine demonstrated a manageable tolerability profile. As would be expected of a chemotherapeutic agent the most common adverse events included myelosuppression, nausea, fatigue, diarrhea, vomiting and fever; the most common serious adverse events were febrile neutropenia and pneumonia.
"The data presented at ASH, as well as from other studies using bendamustine, gives us great optimism that TREANDA may have an important role to play in the treatment of NHL, chronic lymphocytic leukemia (CLL) and other cancers," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations, Cephalon.
About the Phase 3 Study Design
The Phase 3, multicenter, single-arm study evaluated the efficacy and safety of single-agent bendamustine in 100 patients with indolent NHL whose disease has progressed during or following treatment with rituximab. Patients received bendamustine 120 mg per meters squared intravenously over 60 minutes on days one and two every 21 days for six cycles. At the investigator's discretion, patients could receive up to two additional cycles for a maximum of eight.
In addition to the pivotal Phase 3 data, an abstract of an interim analysis by Dr. Mathias J. Rummel and colleagues reports that the combination of bendamustine plus rituximab appears to be non-inferior to the standard CHOP-R while showing a better tolerability profile. Updated results will be presented on Monday, December 10, 2007 at 11:00 am during the ASH meeting [Abstract #385].
About TREANDA (bendamustine HCl)
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 pathway known as mitotic catastrophe (a disruption of normal cell division). This dual-effect of TREANDA may be attributable to its unique chemical design.
The protocol 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 the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia.
In Europe, Cephalon markets three additional oncology products in 19 countries.
About Cephalon, Inc.
Cephalon, Inc. is an international biopharmaceutical company, recently inducted into the World Economic Forum Community of Global Growth Companies. For 20 years, the company has been dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, 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's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ(R) (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, including the results of any clinical programs with respect to TREANDA or the timing, acceptance or approval of any current or future filings for regulatory approval of TREANDA or other Cephalon Oncology compounds; interpretation of clinical results, particularly with respect to the TREANDA clinical trials; manufacturing development and capabilities; market prospects for its products; sales and earnings guidance; and other statements regarding matters that are not historical facts including statements with respect to the role TREANDA may play in the treatment of NHL, CLL or other cancers. 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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