-----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, EQ2gISMaNqsSHz/yCUSr3uG2iZU+fkqZPFqPQW7p9fCFvtJgNisvPFqGsdxWVgFZ 4URieP8mndInZqModWKcwg== 0000950131-96-002793.txt : 19960617 0000950131-96-002793.hdr.sgml : 19960617 ACCESSION NUMBER: 0000950131-96-002793 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19960507 ITEM INFORMATION: Other events FILED AS OF DATE: 19960614 SROS: NASD 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: 96580979 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 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 7, 1996 ----------------------------------- (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) (215) 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 May 7, 1996, Cephalon and its partner, Chiron Corporation, announced that the U.S. Food and Drug Administration (FDA) has scheduled Myotrophin (rhIGF-1) for review by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee on June 7, 1996. The companies plan to present findings from two completed clinical studies which evaluated Myotrophins utility in treating amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). Data from these studies have been submitted to the FDA in support of a Treatment Investigational New Drug application. The companies plan to submit a New Drug Application (NDA) based upon these studies later this year for clearance to market the drug in the United States. This announcement contains forward-looking statements that involve risks and uncertainties. A full discussion of the companies' operations and financial condition, including factors that may affect future operating results, 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 our current expectations. 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: May 7, 1996 By:/s/ Bruce A. Peacock ------------------------------------- Bruce A. Peacock Executive Vice President and Chief Operating Officer EXHIBIT INDEX ------------- EXHIBIT PAGE - ------- ---- 99.1 Press Release dated May 7, 1996. 5 EX-99.1 2 PRESS RELEASE [LOGO] Cephalon, Inc. Contact: Jason Rubin or Larry Kurtz Mary Fisher Chiron Corp. Cephalon, Inc. (510) 601-2476 (610) 344-0200 145 Brandywine Parkway West Chester, PA 19380-4245 (610) 344-0200 Fax (610) 344-0065 Myotrophin Scheduled for June FDA Advisory Panel Meeting West Chester, PA and Emeryville, CA -- May 7, 1996 -- Cephalon, Inc. (NASDAQ: CEPH) and its partner, Chiron Corporation (NASDAQ: CHIR), announced today that the U.S. Food and Drug Administration (FDA) has scheduled Myotrophin(R) (rhIGF-1) for review by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee on June 7, 1996. The companies plan to present findings from two completed clinical studies which evaluated Myotrophin's utility in treating amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). Data from these studies have been submitted to the FDA in support of a Treatment Investigational New Drug application. The companies plan to submit a New Drug Application (NDA) based upon these studies later this year for clearance to market the drug in the United States. "We appreciate the FDA's invitation to bring these data to an advisory committee at the earliest available date, even before we submit our NDA," said Frank Baldino, Jr., Ph.D., Cephalons president and chief executive officer. "We will continue to work with the agency toward our ultimate goal to have Myotrophin reviewed and cleared for patients with ALS as soon as possible." "The FDA's willingness to review the data at the next available panel meeting demonstrates the agency's commitment to meeting the needs of patients with serious diseases such as ALS," added William J. Rutter, Ph.D., chairman of Chiron. "We look forward to presenting our case for Myotrophin to the advisory committee." Chiron Corporation is a science-driven healthcare company that combines diagnostic, vaccine and therapeutics strategies for controlling disease. Headquartered in Emeryville, near San Francisco, and with operations on four continents, Chiron had revenues in 1995 of more than $1 billion. Cephalon discovers, develops and markets pharmaceutical products for the treatment of neurological disorders. The company's principal focus is on diseases such as ALS, narcolepsy, peripheral neuropathies, Alzheimer's disease, head and spinal injury, and stroke. - continued - Myotrophin Scheduled for June Panel Meeting Page 2 This news release contains forward-looking statements that involve risks and uncertainties. A full discussion of the companies' operations and financial condition, including factors that may affect future operating results, 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 our current expectations. * * * * -----END PRIVACY-ENHANCED MESSAGE-----