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FDA Grants Orphan Drug Designation to TREANDA, an Investigational Treatment for Chronic Lymphocytic Leukemia

FRAZER, Pa., Aug. 29 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company's investigational therapy, TREANDA(R) (bendamustine HCl), for the treatment of chronic lymphocytic leukemia (CLL). According to the National Cancer Institute, CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States.

Orphan drug status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting less than 200,000 Americans annually. The orphan drug designation would entitle Cephalon to a seven-year period of marketing exclusivity in the United States for TREANDA, if approved by FDA for the treatment of CLL.

In the third quarter of 2007, Cephalon plans to submit a new drug application to the FDA for TREANDA for the treatment of patients with CLL. The company also is studying TREANDA for the treatment of patients with indolent (or slowly-progressing) non-Hodgkin's lymphoma (iNHL), who are refractory to the monoclonal antibody rituximab.

Cephalon is committed to advancing medications for orphan diseases. The company's first product, PROVIGIL(R) (modafinil) Tablets [C-IV], was launched with an orphan drug designation for narcolepsy in 1999. Other Cephalon therapies with orphan drug designation include TRISENOX(R) (arsenic trioxide) injection and CEP-701 (lestaurtinib), which is in development.


TREANDA is the first rationally designed purine analog / alkylator hybrid, combining the moieties of an antimetabolite and an alkylator. Preclinical data show 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. These novel dual-action, anti-tumor effects of TREANDA may be attributed 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 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

In 2005, Cephalon created a strategic business unit, Cephalon Oncology, 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, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL), 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 (AML).

About Cephalon, Inc.

Cephalon, Inc. is an international biopharmaceutical company, recently inducted in to 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. Cephalon has delivered a seven-year compound annual growth rate (CAGR) through 2006 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, 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 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 of any filings for regulatory approval of TREANDA; interpretation of clinical results, particularly with respect to the TREANDA clinical trials; 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, Inc.
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