EXHIBIT 99.1
[CEPHALON LOGO]
News
CONTACT:
MEDIA: Sheryl L. Williams
610-738-6493
SWILLLIAM@CEPHALON.COM
Robert W. Grupp
610-738-6402
RGRUPP@CEPHALON.COM
INVESTORS: Robert S. (Chip) Merritt
610-738-6376
CMERRITT@CEPHALON.COM
FOR IMMEDIATE RELEASE
CEPHALON ANNOUNCES POSITIVE RESULTS OF PROVIGIL CLINICAL STUDY
IN SHIFT WORK SLEEP DISORDER
COMPANY TO FILE SUPPLEMENTAL NEW DRUG APPLICATION TO EXPAND
PROVIGIL(R) LABEL
WEST CHESTER, PA - OCTOBER 23, 2002 -- Cephalon, Inc. (Nasdaq: CEPH)
announced today that results of its clinical study evaluating PROVIGIL(R)
(modafinil) C-IV in patients with shift work sleep disorder (SWSD) showed
statistical significance on both primary endpoints of the study.
The 12-week randomized double-blind placebo-controlled study included
209 patients with a ICSD-confirmed diagnosis of shift work sleep disorder
randomized to either 200 mg PROVIGIL or placebo. The ICSD -- or International
Classification of Sleep Disorders -- is widely accepted as a tool for clinical
practice and research in sleep disorders medicine.
Patients in the study received PROVIGIL or placebo as a single dose
given prior to the start of their night shift. The study showed that PROVIGIL
significantly improved wakefulness compared to placebo, as measured by the
Multiple Sleep Latency Test (MSLT), an objective measure of sleepiness
(p less than 0.01). In addition, patients treated with PROVIGIL showed
significant improvement in their clinical condition as measured by the
Clinical Global Impression of Change (CGI-C) when compared to patients
treated with placebo (p less than 0.0001).
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SOURCE: Cephalon, Inc. o 145 Brandywine Parkway o West Chester, PA 19380-4245
o (610) 344-0200 o Fax (610) 344-0065
Cephalon Announces Positive Results of PROVIGIL Study in Shift Work Sleep
Disorder
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PROVIGIL was well tolerated. The most commonly reported adverse events
in this study were consistent with those described in the current product label.
The complete study data are expected to be presented at a major medical meeting
in 2003.
Shift work sleep disorder is classified by the American Academy of
Sleep Medicine as a circadian rhythm sleep disorder. It consists of symptoms of
insomnia or excessive sleepiness that occur in relation to work scheduled during
the habitual hours of sleep. Excessive sleepiness usually occurs during shifts
(mainly nights) and is associated with the propensity to fall asleep and
impaired mental ability because of reduced alertness.
"This is the largest clinical study ever conducted evaluating excessive
sleepiness in patients with shift work sleep disorder," said Dr. Paul Blake,
Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon.
"One of the most important findings from this study was that patients with shift
work sleep disorder have levels of pathological sleepiness at baseline that are
similar to patients with untreated narcolepsy or untreated obstructive sleep
apnea."
Frank Baldino, Jr., PhD, Chairman and CEO of Cephalon, added, "These
positive study results are an important part of our Supplemental New Drug
Application to expand the label for PROVIGIL, which we expect to file with the
Food and Drug Administration by the end of the year."
PROVIGIL
PROVIGIL is the first in a new class of wake-promoting agents. While
its exact mechanism of action is not known, the drug acts selectively in areas
of the brain believed to regulate normal wakefulness. Launched in the U.S. in
February 1999, the drug is currently approved in more than 20 countries for the
treatment of excessive daytime sleepiness associated with narcolepsy. For full
prescribing information about PROVIGIL, please visit HTTP://WWW.PROVIGIL.COM.
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SOURCE: Cephalon, Inc. o 145 Brandywine Parkway o West Chester, PA 19380-4245
o (610) 344-0200 o Fax (610) 344-0065
Cephalon Announces Positive Results of PROVIGIL Study in Shift Work Sleep
Disorder
Page 3
CEPHALON, INC.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and marketing of innovative
products to treat sleep and neurological disorders, cancer and pain.
Cephalon currently employs approximately 1,200 people in the United
States and Europe. U.S. sites include the company's headquarters in West
Chester, Pennsylvania, and offices and manufacturing facilities in Salt Lake
City, Utah. Cephalon's major European offices are located in Guildford, England,
and at Laboratoire L. Lafon in Maisons-Alfort, France. For more information on
Cephalon, please visit HTTP://WWW.CEPHALON.COM.
The company currently markets three proprietary products in the United
States: PROVIGIL(R) (modafinil) Tablets [C-IV], GABITRIL(R) (tiagabine
hydrochloride) and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and more
than 20 products internationally. Full prescribing information on Cephalon's
U.S. products is available by calling 1-800-896-5855.
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SOURCE: Cephalon, Inc. o 145 Brandywine Parkway o West Chester, PA 19380-4245
o (610) 344-0200 o Fax (610) 344-0065