-----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, KloVbqI+4bjd1ubY88PHkG05uOtqCVw+o+xVjWDEfXhRoap387PoM1v1BEZeFt4j 98JrEjsagXvSeK9uMRQmgw== 0000891092-97-000477.txt : 19971210 0000891092-97-000477.hdr.sgml : 19971210 ACCESSION NUMBER: 0000891092-97-000477 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19971209 ITEM INFORMATION: FILED AS OF DATE: 19971209 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMCLONE SYSTEMS INC/DE CENTRAL INDEX KEY: 0000765258 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042834797 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-19612 FILM NUMBER: 97734879 BUSINESS ADDRESS: STREET 1: 180 VARICK ST CITY: NEW YORK STATE: NY ZIP: 10014 BUSINESS PHONE: 2126451405 MAIL ADDRESS: STREET 1: 180 VARICK ST CITY: NEW YORK STATE: NY ZIP: 10014 8-K 1 FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 ------------------- FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): December 4, 1997 IMCLONE SYSTEMS INCORPORATED (Exact Name of Registrant as Specified in its Charter) Delaware 0-19612 04-2834797 (State or other Jurisdiction (Commission (IRS Employer Identification of Incorporation) File Number) Number) 180 Varick Street, New York, New York 10014 (Address of Principal Executive Offices) (Zip Code) (212) 645-1405 Registrant's telephone number, including area code ITEM 5. OTHER EVENTS On December 4, 1997, ImClone Systems Incorporated ("ImClone") and Merck KGaA, Darmstadt, Germany announced that the two companies are signing a co-marketing agreement for BEC2, ImClone's therapeutic cancer vaccine. The agreement amends and expands their 1990 agreement for the development and marketing of BEC2. Under the terms of the agreement, Merck KGaA and ImClone will continue to develop BEC2 for the U.S. and international markets with the intent upon registration of establishing separate ethical oncology sales forces for the co-marketing of BEC2 in North America. Merck KGaA will continue to hold an exclusive royalty bearing license to market BEC2 outside North America. Merck KGaA will also be responsible for funding the clinical development of BEC2 worldwide for a single indication, expenses for which had earlier been shared by the parties. It is the intent of the parties that ImClone will be the manufacturer of the product worldwide. The agreement calls for $15 million in milestone fees beyond those previously established under the 1990 agreement. In addition, Merck KGaA has agreed to purchase immediately $40 million of ImClone convertible preferred stock. In the first two years, up to one-quarter of the total preferred stock may be converted into ImClone common stock at a price of $12.50 per share. In subsequent years, Merck KGaA has the option to convert additional preferred shares at varying prices related to the then market price of ImClone common stock. The amendment modifies the 1990 Research and License Agreement between ImClone and Merck KGaA to develop therapeutic cancer vaccines, including BEC2, for the use in small cell lung carcinoma and malignant melanoma. In May 1996, ImClone announced the extension and modification of the collaboration including additional license fees and milestone payments. BEC2 is a proprietary anti-idiotypic monoclonal antibody designed to mimic GD3, a glycolipid (ganglioside) antigen which is found on the surface of a number of tumor cells, including small cell lung cancer (SCLC), melanoma and a variety of soft tissue sarcomas. BEC2 is intended to elicit a cancer-fighting immune response in patients with these tumor cells. On May 19, 1997, at the 33rd American Society of Clinical Oncology Annual Meeting, ImClone and Merck KGaA reported data from its pilot study investigating the effects of BEC2 treatment among 15 patients with small cell lung cancer. The data from the study conducted at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York supports previously reported clinical results that the compound significantly increased survival for patients with small cell lung cancer. Except for the historical information contained herein, the matters discussed herein include forward-looking statements. Actual results may differ materially from those predicted in such forward-looking statements due to the risks and uncertainties inherent in ImClone's business, including, without limitation, risks and uncertainties in obtaining and maintaining regulatory approval, market acceptance of and continuing demand for ImClone's products, the impact of competitive products and pricing, and ImClone's ability to obtain additional financing to support its operations and achieve its objectives. 2 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. IMCLONE SYSTEMS INCORPORATED Date: December 9, 1997 By:/s/ John B. Landes ------------------------------- John B. Landes Vice President, Business Development and General Counsel 3 -----END PRIVACY-ENHANCED MESSAGE-----