EXHIBIT 2004
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`EXHIBIT 2004
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`EXHIBIT 2004 0001
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`Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lym...
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`FDA Approves Treanda
`Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic
`Leukemia
`First New Agent for CLL Patients Approved by the FDA since 2001
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`FRAZER, Pa., March 20, 2008 /PRNewswire-FirstCall/ -- Cephalon, Inc. today announced that the U.S.
`Food and Drug Administration (FDA) has approved Treanda (bendamustine hydrochloride) for Injection
`for the treatment of patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and
`bone marrow disease. The American Cancer Society estimates that more than 15,000 new cases of
`this rare disease will be diagnosed in the United States this year. The Treanda application as a CLL
`treatment received priority review from the FDA and was approved within six months of the September
`2007 submission. Cephalon anticipates that Treanda will be available to physicians and patients as a
`CLL treatment in the United States in April 2008.
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`"Treanda is an important new treatment for patients with chronic lymphocytic leukemia, and this first-
`cycle approval by FDA represents a significant milestone in the growth of our oncology business," said
`Dr. Lesley Russell, Executive Vice President, Worldwide Medical
`and Regulatory Operations. "With a
`strong pipeline of near- and longer-term opportunities, Cephalon Oncology is poised to deliver
`therapies that target both hematologic cancers and solid tumors for patients in need of new options."
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`Dr. Bruce Cheson, Clinical Professor of Hematology/Oncology, Georgetown University School of
`Medicine, Washington D.C., stated, "Patients with chronic lymphocytic leukemia can often live normal
`lives for many years because of treatments that control the disease over the long-term. Treanda is an
`effective new option that offers a delay in disease progression, an important goal for patients with
`chronic lymphocytic leukemia."
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`In a randomized, international, multicenter, open-label pivotal study of 301 treatment-naive patients with
`CLL, those who received Treanda had better clinical outcomes compared to patients treated with
`chlorambucil, an FDA-approved chemotherapy for patients with CLL. Specifically, Treanda patients had
`a significantly higher overall response (59 percent of patients responded to Treanda and 26 percent of
`patients responded to chlorambucil; p < 0.0001). Patients who received Treanda also had a higher
`complete response rate than those treated with chlorambucil (8 percent vs. <1 percent), which means
`that after treatment with Treanda, some patients had no signs of disease in their blood.
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`Importantly, Treanda patients also had a significantly longer progression- free survival (18 months vs. 6
`months; Hazard Ratio = 0.27; p < 0.0001), meaning the disease did not get worse for a significant
`period of time. The response to Treanda lasted longer (duration of response) than in patients who
`received chlorambucil (19 months vs. 7 months). The most common adverse events in the trial were
`myelosuppression, fever, nausea, and vomiting.
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`Treanda has been granted orphan drug status by the FDA for the treatment of CLL. The orphan drug
`designation will provide marketing exclusivity in this indication until March 2015.
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`About Treanda
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`http://www.drugs.com/newdrugs/cephalon-receives-fda-approval-treanda-novel-chemother...
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`1/20/2016
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`CEPHALON, INC. -- EXHIBIT 2004 0001
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`Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lym...
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`Treanda has a unique chemical structure with two primary components, an alkylating group and a
`benzimidazole component. Preclinical data suggest that Treanda can lead to cell death via several
`pathways. 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 (non-apoptotic) pathway known
`as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of Treanda
`remains unknown.
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`In December 2007, Cephalon submitted an NDA requesting approval of Treanda for the treatment of
`patients with indolent (slow-growing) non-Hodgkin's lymphoma who have progressed during or
`following treatment with rituximab or a rituximab-containing regimen and anticipates a review decision
`by October 31, 2008. The protocol for the Treanda NHL pivotal trial received special protocol
`assessment (SPA) approval from the FDA in February 2006. The SPA process allows for FDA
`evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and/or data
`analysis.
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`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. 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 Asia Pacific
`Rim countries.
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`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
`(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.
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`In Europe, Cephalon markets three additional oncology products in 19 countries.
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`About Cephalon, Inc.
`Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company 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. The
`company's European headquarters are located in Maisons-Alfort, France.
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`The company's proprietary products in the United States include: Provigil (modafinil) Tablets [C-IV],
`Fentora (fentanyl buccal tablet) [C-II], Trisenox (arsenic trioxide) injection, Treanda, Amrix
`(cyclobenzaprine hydrochloride extended-release capsules), Vivitrol (naltrexone for extended-release
`injectable suspension), Gabitril (tiagabine hydrochloride), Nuvigil (armodafinil) Tablets [C-IV] and Actiq
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`http://www.drugs.com/newdrugs/cephalon-receives-fda-approval-treanda-novel-chemother...
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`1/20/2016
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`CEPHALON, INC. -- EXHIBIT 2004 0002
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`Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lym...
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`(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.
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`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 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, including the anticipated availability of Treanda in the United States
`or the benefits Treanda may provide; 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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`CONTACT: Media, Jenifer Antonacci, +1-610-738-6674, ;or Candace Steele, +1-610-727-6231, ;
`Investors, Robert'Chip' Merritt, +1-610-738-6376, jantonac@cephalon.com csteele@cephalon.com
`cmerritt@cephalon.com
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`Web site: http://www.cephalon.com/
`Company News On-Call: http://www.prnewswire.com/comp/134563.html /
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`Ticker Symbol: (NASDAQ-NMS:CEPH)
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`Terms and conditions of use apply
`Copyright © 2008 PR Newswire Association LLC. All rights reserved.
`A United Business Media Company
`
`Posted: March 2008
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`Related Articles:
`• Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-
`Hodgkin's Lymphoma - November 3, 2008
`• FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-
`Hodgkin's Lymphoma - February 19, 2008
`• Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with
`Relapsed Indolent Non-Hodgkin's Lymphoma - January 2, 2008
`
`http://www.drugs.com/newdrugs/cephalon-receives-fda-approval-treanda-novel-chemother...
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`1/20/2016
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`CEPHALON, INC. -- EXHIBIT 2004 0003
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`Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lym...
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`Page 4 of 4
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`• Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted
`Priority Review Status by FDA - December 3, 2007
`• Cephalon Submits New Drug Application for Treanda for the Treatment of Chronic
`Lymphocytic Leukemia - September 21, 2007
`• Cephalon Announces Plans for New NDA Filing for Treanda - June 28, 2007
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`Treanda (bendamustine hydrochloride) FDA Approval History
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`http://www.drugs.com/newdrugs/cephalon-receives-fda-approval-treanda-novel-chemother...
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`1/20/2016
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`CEPHALON, INC. -- EXHIBIT 2004 0004