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Cephalon, Inc. Oncology Compound Lestaurtinib (CEP-701) Granted Orphan Drug Designation For Acute Myeloid Leukemia

Published: Apr 04, 2006

FRAZER, Pa., April 4 /PRNewswire-FirstCall/ -- Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for lestaurtinib (CEP-701) for the treatment of acute myeloid leukemia (AML). The orphan drug designation will provide a seven-year period of marketing exclusivity for this indication from the date of final FDA marketing approval of the compound.

FDA may designate a medication as an orphan drug if the product is intended to treat a rare disease or condition affecting less than 200,000 Americans annually. An estimated 12,000 people in the United States were diagnosed with AML in 2005, according to the American Cancer Society. Approximately 25-30 percent of these patients have a FLT-3 genetic mutation that is associated with a poorer prognosis for relapse and survival.

Lestaurtinib

Discovered by Cephalon scientists, lestaurtinib is a potent inhibitor of several tyrosine kinases including FLT-3 and TrkA. This orally active, investigational compound is in a Phase 2/3 clinical trial. It is a targeted agent against AML in patients at first relapse from standard induction chemotherapy and whose disease presents with a genetic alteration known as a FLT-3 activating mutation.

Cephalon Oncology Portfolio

The Cephalon Oncology portfolio includes three lead compounds targeted for patients with hematologic cancers: TRISENOX(R) (arsenic trioxide) injection, an intravenous targeted therapy approved for refractory or relapsed acute promyelocytic leukemia; TREANDA(R) (bendamustine HCl), an investigational multi-functional hybrid cytotoxic in a Phase 3 study for relapsed indolent non-Hodgkin's lymphoma; and lestaurtinib. For more information about Cephalon Oncology, visit http://www.cephalononcology.com.

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 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 currently markets four proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], GABITRIL(R) (tiagabine hydrochloride) Tablets, ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and TRISENOX, and 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 CEP-701; interpretation of clinical results, including the preliminary data from the CEP-701 clinical trial; prospects for regulatory approval of our product candidates; 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.

Cephalon, Inc.

CONTACT: Media: Robert W. Grupp, +1-610-738-6402, rgrupp@cephalon.com, orInvestors: Robert (Chip) Merritt, +1-610-738-6376, cmerritt@cephalon.com,both of Cephalon, Inc.

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