NUVIGIL Jet Lag Disorder Data Presented at the SLEEP 2009 23rd Annual Meeting of...

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Wed Jun 10, 2009 3:30pm EDT

NUVIGIL Jet Lag Disorder Data Presented at the SLEEP 2009 23rd Annual Meeting
of the Associated Professional Sleep Societies

Data Show That NUVIGIL Improves Excessive Sleepiness Associated with Jet Lag
Disorder

FRAZER, Pa., June 10 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH)
presented results from a pivotal trial that showed NUVIGIL(R) (armodafinil)
Tablets [C-IV] significantly improved wakefulness in people with excessive
sleepiness associated with jet lag disorder.  These phase three data were
presented today at the SLEEP 2009 23rd Annual Meeting of the Associated
Professional Sleep Societies meeting in Seattle, Washington.  NUVIGIL is
currently indicated to improve wakefulness throughout the day for the millions
of patients who struggle with excessive sleepiness associated with treated
obstructive sleep apnea, shift work disorder and narcolepsy.  

"We know that jet lag disorder affects approximately two-thirds of
international travelers and that eastbound flight across multiple time zones
can be particularly troublesome.  We are excited to present our data at a
major scientific meeting about the use of NUVIGIL in acute excessive
sleepiness associated with jet lag disorder," said Dr. Lesley Russell, Chief
Medical Officer and Executive Vice President at Cephalon.  "Based on the
findings of this study, Cephalon will submit a supplemental New Drug
Application to the U.S. Food and Drug Administration during the third quarter
of this year."

This novel phase three, randomized, double-blind, placebo-controlled study
evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy
men and women aged 18 to 65 over the course of three days.  Study participants
all had experienced jet lag symptoms at least once during the previous five
years.  Participants in the study traveled eastbound from the United States to
France, where they were then evaluated at a sleep facility. Clinical efficacy
in the study was demonstrated using two measures: an objective assessment
(Multiple Sleep Latency Test, MSLT), and a subjective assessment (Patient
Global Impression of Severity, PGI-S).  
 
The data showed NUVIGIL significantly improved wakefulness in the
participants, as assessed by the MSLT averaged across days one and two. 
Participants taking NUVIGIL 150mg/day had an average time to fall asleep of
11.7 minutes, compared to 4.8 minutes for subjects taking placebo and 7.7
minutes for subjects taking NUVIGIL 50mg/day (p<0.0001 for both doses compared
with placebo).  An average time to fall asleep of less than 5 minutes on the
MSLT is considered pathological sleepiness and an average time to fall asleep
of greater than 10 minutes is considered within the normal range. 

Researchers also found that NUVIGIL 150mg/day significantly improved
patient-reported clinical condition, as assessed by the mean PGI-S [rating
1=normal to 7=extremely ill], averaged across days one and two, compared with
placebo (1.6 armodafinil 150mg/day versus 1.9 placebo; p=0.04).  NUVIGIL was
generally well-tolerated in the study.  The adverse events reported in this
study are consistent with the current NUVIGIL label. The most common adverse
events observed more frequently with NUVIGIL use compared to placebo (greater
than or equal to five percent), included headache, nausea, diarrhea and
palpitations. 

"Following travel across multiple time zones, many travelers can schedule
their meetings or activities to take place after their bodies have adjusted to
the local time zone.  Others may not have these options and must conduct their
daily activities while functionally impaired and excessively sleepy due to the
time zone change," said Dr. Richard Bogan, Primary Investigator for the study,
Chief Medical Officer of Sleep Med Inc., and Clinical Associate Professor of
Medicine, University of South Carolina School of Medicine.  "We now have data
that show NUVIGIL can play a role in addressing the primary symptom of
excessive sleepiness associated with jet lag disorder due to eastbound
travel."

Jet lag disorder is an acute circadian rhythm sleep disorder that results from
rapid travel across several time zones.  This disorder affects approximately
70 million American travelers annually and gradually resolves once a person
adjusts to the new local time. 

Circadian rhythm sleep disorders are disruptions in a person's internal body
clock, which controls sleep patterns.  When the internal body clock is
disrupted, certain symptoms may develop affecting a person's ability to sleep,
stay awake and function normally.  Circadian rhythm sleep disorders can be
caused by many factors, including shift work, time zone changes and medical
conditions. 

About NUVIGIL

NUVIGIL, the longer-lasting formulation of modafinil, was launched in the
United States in June 2009 and is indicated to improve wakefulness in patients
with excessive sleepiness associated with treated obstructive sleep apnea
(OSA), shift work sleep disorder, also known as shift work disorder (SWD) and
narcolepsy.  NUVIGIL is not currently indicated for the treatment of jet lag
disorder or its associated symptoms. The NUVIGIL label includes a bolded
warning for serious or life-threatening rash, including Stevens-Johnson
Syndrome, that has been reported in adults and children taking modafinil, a
racemic mixture of S and R modafinil (the latter is armodafinil, the active
ingredient in NUVIGIL).  NUVIGIL is not approved for use in pediatric patients
for any indication.  

The most common adverse events in controlled clinical trials (greater than 5
percent) were headache, nausea, dizziness, and insomnia.  Full prescribing
information for NUVIGIL is available at www.NUVIGIL.com. 

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,
TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R)
(cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R)
(fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection,
GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) 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 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, clinical development of NUVIGIL, 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.

    Contacts:
    Media:                      Investor Relations:
    Candace Steele              Chip Merritt
    610-727-6231 (office)       610-738-6376 (office)
    csteele@cephalon.com        cmerritt@cephalon.com



SOURCE  Cephalon, Inc.

Media: Candace Steele, +1-610-727-6231, csteele@cephalon.com, or Investor
Relations: Chip Merritt, +1-610-738-6376, cmerritt@cephalon.com
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