-----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, EoYtMRgycXCecBEEH2P3pt1Xw02DIwv3LW8D9DpU5fiSkmlZt/4amJnxmj5MrMOd 6loXL/ExACPN/7MbRYIcTA== 0000893220-97-000914.txt : 19970512 0000893220-97-000914.hdr.sgml : 19970512 ACCESSION NUMBER: 0000893220-97-000914 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970508 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 19970509 SROS: NONE FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19119 FILM NUMBER: 97598613 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 FORM 8-K FOR CEPHALON, INC. 1 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 May 8, 1997 (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) 2 ITEM 5. OTHER EVENTS. On May 8, 1997, Cephalon, Inc. (the "Registrant") announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration had found, by a vote of 6 to 3, that there was not substantial evidence that MYOTROPHIN(R) (rhIGF-1 or mecasermin) Injection is effective in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The Registrant hereby incorporates by reference the Press Release, which is attached hereto as Exhibit 99.1 and made a part hereof, into 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. 3 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: May 8, 1997 By: /s/ Bruce A. Peacock --------------------- Bruce A. Peacock Executive Vice President and Chief Operating Officer 4 EXHIBIT INDEX EXHIBIT PAGE - ------- ---- 99.1 Press Release dated May 8, 1997 EX-99.1 2 PRESS RELEASE DATED MAY 8, 1997 1 EXHIBIT 99.1 Contact: Jason Rubin Larry Kurtz Cephalon, Inc. Chiron Corp. (610) 344-0200 (510) 923-2476 FOR IMMEDIATE RELEASE Cephalon and Chiron Announce Results of FDA Advisory Committee Meeting West Chester, Pa., and Emeryville, Calif. - May 8, 1997 - The U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous Systems Drugs Advisory Committee today found, by a vote of 6 to 3, that there was not substantial evidence that MYOTROPHIN(R) (rhIGF-1 or mecasermin) Injection is effective in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The committee's finding was requested by the FDA in conjunction with its review of a New Drug Application (NDA) submitted by Cephalon, Inc. (NASDAQ:CEPH) and Chiron Corp. (NASDAQ:CHIR) for clearance to market MYOTROPHIN Injection for the treatment of ALS. In response to the committee's vote, Frank Baldino, Jr., Ph.D., Cephalon's president and chief executive officer, and William Rutter, Ph.D., Chiron's chairman, stated, "We are deeply disappointed with the committee's finding about MYOTROPHIN Injection. We appreciate the many expressions of support from patients, caregivers and physicians and will be reviewing with the FDA the panel's recommendation." Cephalon, Inc., headquartered in West Chester, PA, is an international biopharmaceutical company that discovers, develops and markets products to treat neurological disorders. The company is developing products for the treatment of ALS, narcolepsy, peripheral neuropathies, Alzheimer's disease, head and spinal injury, and stroke, and currently copromotes two products in the United States for the treatment of neurological conditions. Chiron Corporation, headquartered in Emeryville, Calif., near San Francisco, is a science-driven, market-directed healthcare company that combines diagnostic, vaccine and therapeutic strategies for controlling disease. Chiron participates in four global healthcare markets: diagnostics, including immunodiagnostics, critical care diagnostics and new quantitative probe tests; therapeutics, with an emphasis on oncological, infectious, neurological and cardiovascular disease; pediatric and adult vaccines; and ophthalmic surgical products for the correction of vision. Chiron also conducts research and development in the fields of biological proteins, gene therapy and combinatorial chemistry. This news release may contain forward-looking statements that involve risks and uncertainties. A full discussion of the companies' operations and financial condition, including factors that may affect their business and future prospects, is contained in documents the companies file with the SEC, such as form 10-Q and 10-K reports. These documents identify important factors that could cause the companies' actual performance to differ from current expectations. -----END PRIVACY-ENHANCED MESSAGE-----