-----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, KjugX+QtbOAuD7o9iLXXSC2YO6uT7s9QN3tDolaiMcwE/sz+k4/LL3J21zKuDuhR B87H9wCsDNGRmVjJchhAGg== 0001036050-98-001628.txt : 19980924 0001036050-98-001628.hdr.sgml : 19980924 ACCESSION NUMBER: 0001036050-98-001628 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19980915 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19980923 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: SEC FILE NUMBER: 000-19119 FILM NUMBER: 98713195 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. 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 September 15, 1998 --------------------------------- (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 On September 15, 1998, Cephalon, Inc. (the "Registrant") announced that Cephalon-Chiron B.V. has withdrawn its application to the European Medicines Evaluation Agency (EMEA) seeking clearance to market MYOTROPHIN(R) (mecasermin) Injection in Europe for the treatment of amyotrophic lateral sclerosis (ALS or motor neuron disease). On September 18, 1998, the Registrant announced the first findings from preclinical studies of its compound, CEP-701, for the treatment of pancreatic ductal adenocarcinoma (PDAC). The results presented on September 18, 1998 at the Baltic Pancreas Meeting in Germany demonstrate that CEP-701 can significantly decrease tumor growth as well as inhibit tumor cell invasion in PDAC animal models. The Registrant hereby attaches both releases as Exhibits 99.1 and 99.2, respectively, which are thereby 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: September 23, 1998 By: /s/ Bruce A. Peacock ------------------ --------------------------------------- Bruce A. Peacock Executive Vice President and Chief Operating Officer EXHIBIT INDEX ------------- EXHIBIT PAGE - ------- ---- 99.1 Press Release dated September 15, 1998 99.2 Press Release dated September 18, 1998 EX-99.1 2 PRESS RELEASE DATED SEPTEMBER 15, 1998 Contact: Jason Rubin Liz Shanahan (Europe) Cephalon, Inc. Sante Communications 610-738-6302 011-44-1-71-379-7377 FOR IMMEDIATE RELEASE - --------------------- Cephalon and Chiron Withdraw Application to Market Myotrophin in Europe West Chester, PA - September 15, 1998 - Cephalon, Inc. (NASDAQ: CEPH) announced today that Cephalon-Chiron B.V. has withdrawn its application to the European Medicines Evaluation Agency (EMEA) seeking clearance to market MYOTROPHIN (mecasermin) Injection in Europe for the treatment of amyotrophic lateral sclerosis (ALS or motor neuron disease). This decision was based on difficulties in resolving issues raised by the Rapporteurs concerning the differences in response seen in the two pivotal studies, and whether a benefit measured by slowing disease progression, using a functional rating scale, is considered clinically relevant. "It is not possible to resolve these issues within the timeframe allotted to the review process," stated Frank Baldino, Jr., Ph.D., Cephalon's president and chief executive officer. "Until these important issues are resolved, we do not believe it is worthwhile to proceed further towards a decision on this application." 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 and cancer. In addition to historical facts, this press release may contain forward- looking statements that involve risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. These statements are based on the company's current belief as to the possibility and timing of future events. Actual results could differ materially from those reflected in the forward-looking statements. Factors which could cause actual results to differ from the company's expectations include, without limitation, the nature of regulatory decisions, the pricing of competitive products, the impact of litigation, risks commonly associated with development and commercialization of drugs and other specific factors that could cause the company's performance to differ from current expectations. These risks are described in documents the company files with the SEC, such as the most recent reports on Form 8-K, Form 10-Q and/or Form 10-K. NOTE: Cephalon's press releases are posted on the Internet at the company's Web site at http://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. EX-99.2 3 PRESS RELEASE DATED SEPTEMBER 18, 1998 Contact: Sandra Menta 610-738-6376 FOR IMMEDIATE RELEASE - --------------------- Cephalon Presents Research Results from Pancreatic Cancer Studies West Chester, PA - September 18, 1998 - Cephalon, Inc. (NASDAQ: CEPH) announced today the first findings from preclinical studies of its compound, CEP-701, for the treatment of pancreatic ductal adenocarcinoma (PDAC). The results presented today at the Baltic Pancreas Meeting in Germany demonstrate that CEP-701 can significantly decrease tumor growth as well as inhibit tumor cell invasion in PDAC animal models. Pancreatic cancer is the fifth most common cause of cancer deaths in the United States. The mean survival time of this highly aggressive cancer is four to six months after diagnosis. Current treatments including chemotherapy, radiation therapy and surgery, either separately or in combination, are not sufficient to significantly increase patient survival time. As reported at today's meeting by Cephalon's Dr. Bruce A. Ruggeri, CEP-701 demonstrated anti-tumor activity in five of six pancreas tumors transplanted into mice (xenografts). Four out of six of these xenografts also demonstrated inhibition of in vivo tumor cell invasion. Cephalon scientists tested CEP-701 alone and in combination with the drug, gemcitabine, finding that dual treatment with gemcitabine was more effective in inhibiting growth of PDAC xenografts than either compound alone. CEP-701 is one of a series of specific receptor trk kinase inhibitors derived from the indolocarbazole K252a, which was originally synthesized by Kyowa Hakko Kogyo Co., Ltd., Tokyo, Japan. PDAC specimens overexpress receptor trk kinases which bind to growth factors associated with tumor growth and invasiveness. Thus, inhibition of these receptor trk kinases allows for the opportunity of therapeutic intervention. Although the findings presented today are preliminary, they provide the impetus to further investigate the role of CEP-701 as a potential therapy for pancreatic cancer. In its agreement with Kyowa Hakko, Cephalon has rights to a series of molecules, including CEP-701, in the United States and Europe. Cephalon has been developing these molecules for the potential use in treating prostate and other cancers, of which CEP-701, as an orally-active molecule, is currently in Phase 1 clinical studies in the U.S. 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 and cancer. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Such statements may be identified by, among other things, the use of forward-looking terminology such as "believes," or by discussions of strategy or intention. These forward- looking statements, such as any statements regarding present or anticipated scientific progress, development of potential pharmaceutical products, manufacturing development and capabilities, and other statements regarding matters that are not historical facts, or otherwise involve beliefs or predictions. The company's performance and financial results could differ materially from those reflected in the 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 in documents filed by the company with the SEC (including, but not limited to, its most recent reports on Form 8-K, Form 10-Q and Form 10-K). Given these uncertainties, current or prospective investors are cautioned not to place undue reliance on any such forward-looking statements. Furthermore, the company disclaims any obligation or intent to update any such factors or forward-looking statements to reflect future events or developments. NOTE: Cephalon's press releases are posted on the Internet at the company's Web site at http://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-----