Mayo Clinic Proceedings Publishes Study of NUVIGIL in Patients with Shift Work Disorder

Mayo Clinic Proceedings Publishes Study of NUVIGIL in Patients with Shift Work
Disorder

FRAZER, Pa., Nov. 2 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH)
today announced that the November issue of Mayo Clinic Proceedings has
published data from a pivotal Phase III trial demonstrating that NUVIGIL®
(armodafinil) Tablets [C-IV] significantly improved wakefulness throughout the
shift in patients with excessive sleepiness associated with shift work
disorder (SWD). NUVIGIL, the longer-lasting isomer of modafinil, is indicated
to improve wakefulness in patients with excessive sleepiness associated with
shift work disorder, treated obstructive sleep apnea and narcolepsy. These
data were part of the new drug application approved by the FDA in 2007.

This Phase III 12-week, randomized, double-blind, placebo-controlled study
evaluated 254 permanent or rotating shift workers with shift work disorder at
42 sleep research centers in the United States and Canada. Study patients
received NUVIGIL (150 mg) or a placebo at approximately one hour before each
night shift. During weeks four, eight and 12, patients spent a night shift in
the sleep laboratory, where investigators assessed patients' physiological
propensity to fall sleep during night shift hours and clinicians' impression
of disease severity, and patient-reported level of sleepiness.

The study showed that patients wakefulness significantly improved over the
course of the trial in patients taking NUVIGIL (by 3.1 minutes) versus those
on placebo (by 0.4 minutes) (P<0.001). This primary endpoint was evaluated by
the Multiple Sleep Latency Test, which measured patients' time to fall asleep
at specific times during the night shift.

"These findings are important, given that approximately 15 percent of U.S.
employees work during nighttime hours and many may have symptoms of shift work
disorder," said Thomas Roth, PhD, director of the Henry Ford Hospital Sleep
Disorders and Research Center in Detroit and an investigator in the study.
"The results establish the potential benefits of armodafinil (NUVIGIL) for
patients with excessive sleepiness associated with shift work disorder."

Researchers also found that a significantly greater proportion of patients
receiving NUVIGIL (79 percent) than placebo (59 percent) (P=0.001) improved,
as evaluated by Clinical Global Impressions of Change (CGI-C), which measured
overall wellbeing as related to sleepiness during night shifts including the
commute to and from work. In addition, patients taking NUVIGIL showed
improvement as measured by the Karolinska Sleepiness Scale (KSS), a
patient-related subjective measure of sleepiness.

In this study, NUVIGIL was not found to affect daytime sleep, as measured by
polysomnography (an objective measure of sleep), although two percent of
patients reported insomnia. The most commonly reported adverse events in
patients who received NUVIGIL were headache, nausea, nasopharyngitis
(inflammation of the nasal passages and the upper throat) and anxiety.

ABOUT SHIFT WORK DISORDER

Shift work disorder is an important yet seldom recognized medical condition in
which a person's internal clock, which helps regulate the cycle of sleeping
and waking, is out of sync with his or her work schedule. The disorder is
often triggered when people work outside of traditional work hours. Those
affected by shift work disorder experience excessive sleepiness or insomnia to
an extent that it is difficult for them to function effectively at work.

ABOUT NUVIGIL

NUVIGIL is indicated to improve wakefulness in patients with excessive
sleepiness associated with treated obstructive sleep apnea, shift work sleep
disorder, also known as shift work disorder (SWD) and narcolepsy. The NUVIGIL
label includes a bolded warning for serious or life-threatening rash,
including Stevens-Johnson syndrome, which 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.

Patients should be advised that their level of wakefulness may not return to
normal. Patients should be frequently reassessed for their degree of
sleepiness and, if appropriate, advised to avoid driving or any other
potentially dangerous activity.

Although NUVIGIL has not been shown to produce functional impairment, any drug
affecting the central nervous system may alter judgment, thinking or motor
skills. Patients should be cautioned about operating an automobile or other
hazardous machinery until reasonably certain that NUVIGIL therapy will not
adversely affect their ability to engage in such activities.

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

ABOUT CEPHALON

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/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.

Media: Investors:
Candace Steele Flippin Chip Merritt
(610) 727-6231 (610) 738-6376
csteele@cephalon.com cmerritt@cephalon.com

SOURCE Cephalon, Inc.

Media: Candace Steele Flippin, +1-610-727-6231, csteele@cephalon.com, or
Investors: Chip Merritt, +1-610-738-6376, cmerritt@cephalon.com, both of
Cephalon