EX-99.1 3 a2092405zex-99_1.txt EX-99.1 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). -- MORE -- -------------------------------------------------------------------------------- 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 2 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. -- MORE -- -------------------------------------------------------------------------------- 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. 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 "WILL," "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. # # # -------------------------------------------------------------------------------- SOURCE: Cephalon, Inc. o 145 Brandywine Parkway o West Chester, PA 19380-4245 o (610) 344-0200 o Fax (610) 344-0065