-----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, MAdASTEWvgOOiuUsK2q1htrXBYCEJSXMRNtK3JMdpyM2fXbAYOLis6nc7jiVIPE3 37TfYtpxdHPjdzxlbdKsLQ== /in/edgar/work/20001103/0000912057-00-047042/0000912057-00-047042.txt : 20001106 0000912057-00-047042.hdr.sgml : 20001106 ACCESSION NUMBER: 0000912057-00-047042 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20001101 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20001103 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: 752351 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 a2029360z8-k.txt CURRENT REPORT 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 NOVEMBER 1, 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 November 1, 2000, Cephalon, Inc. (the "Registrant") publicly announced an agreement whereby Abbott Laboratories will transfer its U.S. products rights to Gabitril(R) (tiagabine hydrochloride), an anti-epileptic product, to Cephalon. The agreement gives Cephalon the exclusive rights to market, sell and further develop the drug in the United States. Cephalon has been co-promoting the product with Abbott since June of 1999. On November 2, 2000, the Registrant announced that it has agreed to pay in full $6.6 million to the noteholders of its outstanding revenue-sharing notes, which were initially issued in February 1999. This payment will retire all obligations associated with the notes, effective as of December 31, 2000, including Cephalon's obligation to pay royalties on the U.S. sales of PROVIGIL(R) (modafinil) Tablets [C-IV] through December 31, 2001. The Registrant hereby incorporates by reference the press releases attached hereto as Exhibits 99.1 and 99.2, 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: November 2, 2000 By: /s/ Frank Baldino, Jr. ---------------- -------------------------- Frank Baldino, Jr. Chairman and Chief Executive Officer EXHIBIT INDEX Exhibit Page - ------- ---- 99.1 Press Release dated November 1, 2000. 99.2 Press Release dated November 2, 2000. EX-99.1 2 a2029360zex-99_1.txt PRESS RELEASE EXHIBIT 99.1 Contact: ABBOTT LABORATORIES CEPHALON, INC. Melissa Brotz Sheryl Williams U.S. Media (610) 738-6493 (847) 935-3456 swilliam@cephalon.com John Thomas Financial Community (847) 938-2655 FOR IMMEDIATE RELEASE: CEPHALON, INC. AND ABBOTT LABORATORIES ANNOUNCE AGREEMENT TO TRANSFER U.S. PRODUCT RIGHTS FOR GABITRIL(R) (TIAGABINE HYDROCHLORIDE) TO CEPHALON WEST CHESTER, Pa., and ABBOTT PARK, Ill., November 1, 2000 -- Cephalon, Inc. (NASDAQ: CEPH) and Abbott Laboratories (NYSE:ABT) announced today an agreement whereby Abbott will transfer its U.S. products rights to Gabitril(R)(tiagabine hydrochloride), one of its anti-epileptic products, to Cephalon. The agreement gives Cephalon the exclusive rights to market, sell and further develop the drug in the United States. Cephalon has been co-promoting the product with Abbott since June of 1999. Under terms of the agreement, Cephalon will pay Abbott $100 million over the next four years, and also will make an additional payment based on the product's patent life. Abbott will continue to manufacture Gabitril for Cephalon, although Cephalon intends to assume direct responsibility for manufacturing within the next several years. The agreement is subject to the approval of regulatory agencies. "We believe that this product has significant growth potential and expect it to contribute to Cephalon's EPS growth," said Frank Baldino, Jr., Ph.D., Cephalon's president and chief executive officer. "Cephalon is excited about the prospect of leveraging our sales experience with the product and further developing Gabitril for additional indications." "This agreement allows us to focus our development and commercial efforts on our largest U.S. pharmaceutical product, Depakote," said Arthur Higgins, senior vice president, pharmaceutical operations, Abbott Laboratories. "Cephalon has been an excellent partner to work with over the past year. We are pleased to transfer the rights to Gabitril to Cephalon, which will be well positioned to maximize its potential from a scientific and commercial standpoint." Gabitril is an adjunctive antiepilepsy drug used for the treatment of partial seizures, a form of epilepsy, in adults and children 12 years and older. Studies have shown that Gabitril is effective in reducing the frequency of partial seizures when added to an existing regimen of at least one other antiepilepsy drug (adjunctive therapy). Double-blind, placebo-controlled, parallel group add-on trials showed a significant reduction in median seizure rates versus placebo. Gabitril has been shown to be well-tolerated with the most common adverse events being dizziness/light-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain and thinking abnormal/difficulty with concentration or attention. As with other antiepileptics, Gabitril should not be stopped abruptly unless medically indicated. Adverse events most often associated with Gabitril were related to the central nervous system. Abbott Laboratories is committed to the research and development of novel treatments for neurological and psychiatric conditions that will enable patients to lead productive lives. Abbott is a global, diversified healthcare company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 58,000 people and markets its products in more than 130 countries. Abbott's news releases and other information, including full prescribing information for Gabitril(R) (tiagabine hydrochloride) and Depakote(R) (divalproex sodium), are available on the company's Web site at WWW.ABBOTT.COM. Following the closing of this product acquisition, Cephalon will have three marketed products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV] is marketed for the treatment of excessive daytime sleepiness associated with narcolepsy, and is being developed for other potential uses; ACTIQ(R) (oral transmucosal fentanyl citrate) is marketed for the treatment of breakthrough cancer pain, and recently was approved in the United Kingdom; GABITRIL(R) (tiagabine hydrochloride) for the adjunctive treatment of partial seizures associated with epilepsy. Cephalon, Inc., headquartered in West Chester, Pa., is an international biopharmaceutical company dedicated to the discovery, development and marketing of products to treat neurological disorders, sleep disorders, cancer and pain. 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. 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. EX-99.2 3 a2029360zex-99_2.txt PRESS RELEASE EXHIBIT 99.2 CONTACT: SHERYL WILLIAMS 610-738-6493 FOR IMMEDIATE RELEASE CEPHALON RETIRES ROYALTY OBLIGATION UNDER REVENUE-SHARING NOTES West Chester, PA -- November 2, 2000 -- Cephalon, Inc. (NASDAQ: CEPH) today announced that it has agreed to pay in full $6.6 million to the noteholders of its outstanding revenue-sharing notes, which were initially issued in February 1999. This payment will retire all obligations associated with the notes, effective as of December 31, 2000, including Cephalon's obligation to pay royalties on the U.S. sales of PROVIGIL(R) (modafinil) Tablets [C-IV] through December 31, 2001. The Company will recognize the $6.6 million payment as a charge to fourth quarter 2000 earnings. 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, cancer and pain. 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-----