-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, M8QWSNL4FWR9g6jZJSQFfwzsC9VESDKPRs0/rUqgdj5bVgKNG09d12wEvFWsdPgv n17nw46271L2G921L14oUg== /in/edgar/work/20000731/0000912057-00-033898/0000912057-00-033898.txt : 20000921 0000912057-00-033898.hdr.sgml : 20000921 ACCESSION NUMBER: 0000912057-00-033898 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20000731 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20000731 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: [2834 ] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-19119 FILM NUMBER: 682623 BUSINESS ADDRESS: STREET 1: 145 BRANDYWINE PKWY CITY: WEST CHESTER STATE: PA ZIP: 19380 BUSINESS PHONE: 6103440200 MAIL ADDRESS: STREET 1: 145 BRANDYWINE PARKWAY CITY: WEST CHESTER STATE: PA ZIP: 19380 8-K 1 a8-k.txt FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 JULY 31, 2000 -------------------------------- (Date of earliest event reported) CEPHALON, INC. -------------------------------- (Exact name of registrant as specified in its charter) DELAWARE 0-19119 23-2484489 - -------------------------------- ------------ -------------- (State or other jurisdiction (Commission (IRS Employer of incorporation or organization) File Number) ID No.) 145 Brandywine Parkway WEST CHESTER, PENNSYLVANIA 19380 - ---------------------------------------- ---------- (Address of principal executive offices) (Zip Code) (610) 344-0200 -------------------------------- (Registrant's telephone number, including area code) NOT APPLICABLE -------------------------------- (Former name, former address and former fiscal year, if changed since last report) ITEM 5. OTHER EVENTS. On July 31,2000, Cephalon, Inc. (the "Registrant") publicly announced that a clinical study of PROVIGIL-Registered Trademark- (modafinil) Tablets [C-IV] in adults with attention deficit hyperactivity disorder (ADHD) showed that compared to placebo PROVIGIL therapy showed no benefit in reducing the symptoms of ADHD, as measured by the DSM-IV ADHD Rating Scale. The Registrant hereby incorporates by reference the press release attached hereto as Exhibit 99.1, and made a part of this Item 5. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS. (a) FINANCIAL STATEMENTS OF BUSINESS ACQUIRED: None (b) PRO FORMA FINANCIAL INFORMATION: None (c) EXHIBITS: Reference is made to the Exhibit Index annexed hereto and made a part hereof. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. CEPHALON, INC. Date: July 31, 2000 By: /s/ Frank Baldino, Jr. --------------------------------- --------------------------- Frank Baldino, Jr. Chairman and Chief Executive Officer EXHIBIT INDEX EXHIBIT PAGE - ------- ---- 99.1 Press Release dated July 31, 2000. EX-99.1 2 ex-99_1.txt PRESS RELEASE CONTACT: SHERYL WILLIAMS 610-738-6493 FOR IMMEDIATE RELEASE Cephalon Reports No Benefit from PROVIGIL in Study of Adults with ADHD PLANS FOR LABEL EXPANSION INTO OTHER INDICATIONS ON TRACK West Chester, PA - July 31, 2000 - Cephalon, Inc. (NASDAQ: CEPH) today announced that a clinical study of PROVIGIL-Registered Trademark- (modafinil) Tablets [C-IV] in adults with attention deficit hyperactivity disorder (ADHD) showed that compared to placebo PROVIGIL therapy showed no benefit in reducing the symptoms of ADHD, as measured by the DSM-IV ADHD Rating Scale. The 113-patient, double-blind, placebo-controlled trial compared the safety and efficacy of 100 mg and 400 mg doses of PROVIGIL to a placebo. PROVIGIL was generally well-tolerated. Cephalon chairman and chief executive officer Frank Baldino, Jr., Ph.D., stated: "While we are disappointed with the results of this study, we feel fortunate that three out of four studies with PROVIGIL reported this year - excessive sleepiness associated with obstructive sleep apnea and shift work and fatigue associated with multiple sclerosis - have been positive. The company is on plan to pursue label expansion of PROVIGIL in the areas of excessive sleepiness and fatigue. In the meantime, PROVIGIL prescriptions have been growing steadily this year and interest among clinicians in evaluating the drug for other indications is high." PROVIGIL is marketed in the United States, the United Kingdom, Austria, Ireland and Italy for the treatment of narcolepsy or the excessive daytime sleepiness associated with narcolepsy. The drug was approved by the Food and Drug Administration in 1998 as a once-a-day therapy to improve wakefulness in patients experiencing excessive daytime sleepiness associated with narcolepsy. The most frequently reported adverse events observed in clinical trials for narcolepsy were headache, nausea, nervousness, anxiety, infections and insomnia. Dr. Baldino will provide a clinical update on PROVIGIL with analysts and investors on a conference call today beginning at 10:00 am EDT. To participate in the call, dial 1-719-457-2622 and refer to Conference Code Number 869516. CEPHALON, INC., HEADQUARTERED IN WEST CHESTER, PENNSYLVANIA, IS AN INTERNATIONAL BIOPHARMACEUTICAL COMPANY DEDICATED TO THE DISCOVERY, DEVELOPMENT AND MARKETING OF PRODUCTS TO TREAT SLEEP DISORDERS, NEUROLOGICAL DISORDERS AND CANCER. - CONTINUE - Cephalon Reports No Benefit from PROVIGIL IN STUDY OF ADULTS WITH ADHD PAGE 2 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 PROJECTIONS, 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 SUCH AS THOSE SET FORTH BELOW AND 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 (AND IT IS NOT OBLIGATED) TO UPDATE PUBLICLY ANY FORWARD-LOOKING STATEMENTS. THIS DISCUSSION IS PERMITTED BY THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. NOTE: CEPHALON'S PRESS RELEASES ARE POSTED ON THE INTERNET AT THE COMPANY'S WEB SITE AT WWW.CEPHALON.COM. THEY ARE ALSO AVAILABLE BY FAX 24 HOURS A DAY AT NO CHARGE BY CALLING PR NEWSWIRE'S COMPANY NEWS ON-CALL AT 800-758-5804, EXTENSION 134563. -----END PRIVACY-ENHANCED MESSAGE-----