Data from Pivotal Study Show Bendamustine Produced a Significant Increase
in Overall Response Rate and Progression Free Survival
FRAZER, Pa., Dec. 10 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that in a pivotal study of treatment-naive patients with chronic lymphocytic leukemia (CLL), those who received TREANDA (bendamustine HCl) had better clinical outcomes compared to patients treated with chlorambucil, an FDA-approved therapy for patients with CLL. TREANDA(R) is a novel investigational chemotherapy that is currently under priority review by the U.S. Food and Drug Administration (FDA). CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States, according to the National Cancer Institute. The final data from this large, international, multi-center study were presented at the 49th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA [Poster # 233-II; Abstract #2043].
"In this study, bendamustine was more effective than chlorambucil in achieving remissions in treatment-naive patients with CLL," said Dr. Wolfgang Knauf, Onkologische Gemeinschaftspraxis, Frankfurt, Germany and lead investigator of this study. "On the basis of these positive results, bendamustine could be an important first-line chemotherapy option for patients with CLL."
Bendamustine demonstrated significantly better outcomes in both of the primary endpoints: overall response rate and progression-free survival (PFS). Overall response rate was significantly higher with bendamustine than with chlorambucil (68% vs. 39%) (p<0.0001) with a strong complete response rate of 30% compared to 2%, a nodular partial response of 10% compared to 3%, and a partial response of 28% compared to 34%, respectively. Bendamustine significantly improved PFS compared to chlorambucil (median PFS 21.7 months vs. 9.3 months (p<.0001)). The median duration of response in the patients treated with bendamustine was 18.9 months compared to 6.1 months for those patients treated with chlorambucil. 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.
"If approved, we believe TREANDA will be an important new treatment option for patients with CLL," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "Based on these study results and other data on bendamustine being presented at ASH, we envision TREANDA as the foundation of our growing oncology portfolio."
About the Phase 3 Study Design
The randomized, international, multicenter, open-label Phase 3 clinical trial evaluated the safety and efficacy of bendamustine compared to chlorambucil in previously untreated patients with B-CLL Binet stage B/C [equivalent to Rai stages I-IV], a measure of disease progression (n=305). Patients received bendamustine (100 mg per meters squared on days 1+2) (n=156) or chlorambucil (0.8 mg/kg on days 1+15) (n=149) for up to six treatment cycles. Safety and efficacy were assessed by an Independent Data Monitoring Committee.
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 FDA granted priority review to the new drug application (NDA) for TREANDA for the treatment 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 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 TREANDA as a future treatment option or as a foundation for the Cephalon oncology portfolio. 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.
|SOURCE Cephalon, Inc.|
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