Pivotal Data Published in the Journal Cancer Demonstrate that TREANDA Induced Durable Responses in Relapsed Indolent Non-Hodgkin's Lymphoma

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Thu Nov 5, 2009 11:00am EST

Pivotal Data Published in the Journal Cancer Demonstrate that TREANDA Induced
Durable Responses in Relapsed Indolent Non-Hodgkin's Lymphoma


FRAZER, Pa., Nov. 5 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH)
today announced the journal Cancer has published a pivotal study demonstrating
that TREANDA® (bendamustine HCl) for Injection induced durable responses in
patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had
progressed during or within six months of treatment with rituximab. Results of
this study, which supported the FDA approval of TREANDA in this patient
population in October 2008, were published online yesterday and will also
appear in the print edition at a later date. According to the National Cancer
Institute, an estimated 30,000 people in the United States will be diagnosed
this year with indolent NHL, a slow growing but serious cancer of the
lymphatic system.   

"The findings from this study confirm and expand upon previous investigations
with bendamustine. Bendamustine provides physicians and patients with another
valuable treatment option for recurring indolent B-cell NHL, a patient
population that continues to grow," said Brad Kahl, M.D., Associate Professor,
Director Lymphoma Service, University of Wisconsin Paul P. Carbone
Comprehensive Cancer Center, and the lead investigator of this study.  

In this multicenter, open-label, single-arm study, 100 patients received
TREANDA intravenously at a dose of 120 mg per meter squared over 60 minutes on
days one and two every 21 days for up to eight cycles. There were two primary
endpoints in the study: the overall response rate (ORR) defined as the
percentage of patients who responded to treatment, and the duration of
response.  In the published results, 75 percent of patients had a response to
treatment with TREANDA, including 14 percent who had a complete response and
three percent who had an unconfirmed complete response.  The patient response
to treatment lasted a median of 9.2 months.  The most common adverse events in
this study included myelosuppression, nausea, infection, fatigue, diarrhea,
vomiting and fever; serious adverse events included febrile neutropenia and
pneumonia. 

About TREANDA 
TREANDA, a novel chemotherapy, was approved by the FDA for the treatment of
chronic lymphocytic leukemia in March 2008. Efficacy relative to first line
therapies other than chlorambucil has not been established. TREANDA received
its second approval in October 2008 for the treatment of patients with
indolent B-cell NHL that has progressed during or within six months of
treatment with rituximab or a rituximab-containing regimen.

The following serious adverse reactions have been associated with TREANDA in
clinical trials: myelosuppression, infections, infusion reactions and
anaphylaxis, tumor lysis syndrome, skin reactions, and other malignancies.

TREANDA has a unique chemical structure that is synthesized to combine an
alkylating group and a purine-like benzimidazole component.  Though the exact
mechanism of action of TREANDA remains unknown, TREANDA may act in two
distinct ways to kill cancer cells. Preclinical studies suggest that TREANDA
may lead to cell death by a process known as apoptosis (programmed cell death)
as well as by an alternate cell death pathway which disrupts normal cell
division known as mitotic catastrophe (a non-apoptotic pathway).

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, the Mundipharma Group of Independent Associated Companies.  In
Germany, bendamustine 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 select Asia Pacific Rim countries. 

About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company
dedicated to the discovery, development and commercialization of many unique
products in four core therapeutic areas: central nervous system, inflammatory
diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500
Index, 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 has a growing presence in Europe, the Middle East and Africa.  The
Cephalon European headquarters and pre-clinical development center are located
in Maisons-Alfort, France, just outside of Paris.  Key business units are
located in England, Ireland, France, Germany, Italy, Spain, the Netherlands
for the Benelux countries, and Poland for Eastern and Central European
countries.  Cephalon Europe markets more than 30 products in four areas:
central nervous system, pain, primary care and oncology. 

The company's proprietary products in the United States include: NUVIGIL®
(armodafinil) Tablets [C-IV], TREANDA, AMRIX® (cyclobenzaprine hydrochloride
extended-release capsules), FENTORA® (fentanyl buccal tablet) [C-II],
TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride),
PROVIGIL® (modafinil) Tablets [C-IV] 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
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,
interpretation of clinical results, prospects for regulatory approval,
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.

    Media:                           Investors:
    Jenifer Antonacci                Robert (Chip) Merritt
    610-738-6674                     610-738-6376
    jantonacci@cephalon.com          cmerritt@cephalon.com


SOURCE  Cephalon, Inc.

Media: Jenifer Antonacci, +1-610-738-6674, jantonacci@cephalon.com; or
Investors: Robert (Chip) Merritt, +1-610-738-6376, cmerritt@cephalon.com, both
of Cephalon, Inc.
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