Healthcare Industry News:  buccal tablet 

Biopharmaceuticals Oncology FDA

 News Release - June 28, 2007

Cephalon Announces Plans for New NDA Filing for TREANDA(R)

The Company Anticipates Third Quarter 2007 Filing for the Treatment of Chronic Lymphocytic Leukemia

FRAZER, Pa., June 28 (HSMN NewsFeed) -- Cephalon, Inc. (Nasdaq: CEPH ) today announced that, based on data from a European study, it now plans to file in the third quarter of 2007 a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for TREANDA® (bendamustine HCl) for the treatment of chronic lymphocytic leukemia (CLL).

"We are pleased to have the opportunity to submit an earlier than expected NDA filing for TREANDA," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "TREANDA offers a new and alternative treatment approach to cancers such as non-Hodgkin's lymphoma and chronic lymphocytic leukemia and underscores our enthusiasm for the spectrum of products and compounds in the Cephalon Oncology portfolio."

A large, multi-center phase 3 clinical trial conducted in Europe evaluated the safety and efficacy of bendamustine, the active ingredient in TREANDA, compared to chlorambucil in patients with treatment-naive B-CLL. The data from this trial met its primary endpoint of overall response rate and will be the basis for the company's NDA filing for the CLL indication. The company anticipates that results from this study will be released at the upcoming American Society of Hematology annual meeting in December 2007.

Cephalon's phase 3 clinical trial evaluating the safety and efficacy of TREANDA in patients with indolent non-Hodgkin's lymphoma (NHL) who are refractory to the monoclonal antibody rituximab remains on schedule. The company anticipates filing an NDA for this indication in the fourth quarter of 2007.

Cephalon's senior management will review the company's product pipeline and discuss research and development initiatives at its Research and Development Day today beginning at approximately 12:00 p.m. EDT and ending at 3:00 p.m. EDT. The presentation will be webcast live on the investor relations section of its website at The webcast will be archived for one week following the broadcast. To access the webcast, log on to the company's website at and click on "Investor Information," then "Webcast." Please click on the link and follow the prompts for registration and access.


TREANDA is the first rationally engineered purine alkylator hybrid designed to combine an alkylator and an antimetabolite. Preclinical data suggest the novel multi-action, anti-tumor effects of TREANDA may be attributed to its unique chemical design. These data show that TREANDA induces rapid, sustained single- and double-strand DNA damage, which results in apoptosis, or programmed cell death in the tumor. The DNA disruption caused by TREANDA appears to be more extensive and durable than that caused by traditional alkylators. TREANDA also induces mitotic checkpoint inhibition, which results in non-apoptotic cell death.

Cephalon holds exclusive rights to market and sell TREANDA in the United States. TREANDA is licensed from Astellas Deutschland GmbH. Bendamustine, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, MundiPharma International Limited, under the tradename RIBOMUSTIN®. 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 in Asia.

About Cephalon Oncology

Cephalon created Cephalon Oncology, 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® (arsenic trioxide) injection, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL), and CEP-701 (lestaurtinib), an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia (AML).

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon has delivered a seven-year compound annual growth rate (CAGR) greater than 75% and 2006 revenue of $1.760 billion. 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® (modafinil) Tablets [C-IV], FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX, VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), 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 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 any clinical programs with respect to TREANDA or the timing of any NDA filings for TREANDA; interpretation of clinical results, particularly with respect to the TREANDA clinical trials or the timing of the release of clinical trial results; manufacturing development and capabilities; market prospects for its products, including the timing of the commercial launch of TREANDA or the clinical utility of TREANDA; 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.

Source: Cephalon

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