FRAZER, Pa., Sept. 21 /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(R) (bendamustine HCl) for the treatment of patients with chronic lymphocytic leukemia (CLL). 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. If approved, TREANDA would be the first new therapy approved by the FDA for the treatment of CLL since 2001. In August 2007, the FDA granted orphan drug designation to TREANDA for this indication.
"This is our first regulatory filing for TREANDA and a significant milestone for our growing oncology portfolio," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "We also are developing TREANDA for the treatment of non-Hodgkin's lymphoma and are planning additional submissions for Cephalon oncology compounds to the FDA over the next 12 months."
The NDA is based on a large, international multi-center Phase 3 clinical trial that evaluated the safety and efficacy of bendamustine HCl, the active ingredient in TREANDA, compared to chlorambucil in patients who were not previously treated for their disease. Chlorambucil is an FDA-approved first- line therapy for patients with CLL. In the pivotal trial, bendamustine HCl met both primary endpoints, overall response and progression-free survival and demonstrated an acceptable tolerability profile. The company anticipates that results from this study will be released at the upcoming American Society of Hematology (ASH) annual meeting in December 2007.
The company also is studying TREANDA for the treatment of patients with indolent (or slowly-progressing) non-Hodgkin's lymphoma (NHL), who are refractory to the monoclonal antibody rituximab. Pending positive results from this ongoing study, the company anticipates filing an NDA for TREANDA in patients with indolent NHL who are refractory to rituximab in the fourth quarter of 2007. In addition, Cephalon is studying TREANDA in combination with rituximab in patients with relapsed indolent and mantle cell NHL. The company anticipates that results from studies of TREANDA as monotherapy and in combination will be presented at medical meetings later this year.
Upon FDA acceptance of the company's NDA filing of TREANDA for CLL, the company will make a $15 million milestone payment to former shareholders of Salmedix.
TREANDA is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that TREANDA induces rapid, sustained single- and double-strand DNA damage, which results in apoptosis, or programmed cell death, in the tumor. TREANDA also induces mitotic checkpoint inhibition, which results in non-apoptotic cell death. TREANDA causes DNA disruption that is both extensive and durable exhibiting a low level of cross-resistance to other cytotoxic agents. The dual-effect of the anti-tumor activity of TREANDA may be attributable to its unique chemical design.
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, 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 market and sell bendamustine HCl in Asia.
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 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 or acceptance 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. 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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