-----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, NH3wnTM8nrqPiD0dQrrObZKwTCcAqw3+w3x7J2yoF/cd0pw4WdmmqmpLXmrSSLFF 0lF7EkU8aEWcSD+tn2OBow== 0000950103-02-000634.txt : 20020626 0000950103-02-000634.hdr.sgml : 20020626 20020626170332 ACCESSION NUMBER: 0000950103-02-000634 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020619 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020626 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: 1934 Act SEC FILE NUMBER: 000-19612 FILM NUMBER: 02688065 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 jun2602_8k.txt ================================================================================ 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 Date of report (Date of earliest event reported): June 19, 2002 IMCLONE SYSTEMS INCORPORATED (Exact Name of Registrant as Specified in Its Charter) Delaware 0-19612 04-2834797 (State of incorporation or (Commission File Number) (I.R.S. Employer organization) Identification No.) 180 Varick Street, 6th Floor, New York, New York 10014 (Address, including zip code of Registrant's principal executive offices) Registrant's telephone number, including area code: (212) 645-1405 ================================================================================ Item 5. Other Events On June 19, 2002, ImClone Systems Incorporated issued a press release announcing receipt of a "Wells Notice" from the staff of the Securities and Exchange Commission. The text of the press release, which is attached as Exhibit 99.1, is incorporated by reference in its entirety. Item 7. Exhibits (c) Exhibits 99.1 Press Release dated June 19, 2002. 2 SIGNATURE 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 hereunto duly authorized. ImClone Systems Incorporated By: /s/ John B. Landes ----------------------------------- Name: John B. Landes Title: Senior Vice President, Legal Date: June 26, 2002 3 EXHIBIT INDEX Exhibit No. Description ----------- ----------- 99.1 Press release dated June 19, 2002. 4 EX-99.1 3 jun2602_ex99-1.txt Exhibit 99.1 Contact: Investors Media Andrea F. Rabney Abernathy MacGregor Vice President Andrew Merrill or David Pitts Corporate Communications (212) 371-5999 ImClone Systems Incorporated (646) 638-5058 For Immediate Release IMCLONE SYSTEMS RECEIVES "WELLS NOTICE" FROM SECURITIES AND EXCHANGE COMMISSION New York, NY -- Jun 19, 2002 -- ImClone Systems Incorporated (NASDAQ: IMCL) announced that it today received a written "Wells Notice" from the staff of the Securities and Exchange Commission (SEC), indicating that the staff is considering recommending the Commission bring an action against the Company relating to the Company's disclosure immediately following its receipt of a Refusal-to-File letter from the FDA on December 28, 2001 for its biologics license application for ERBITUX. Under the Wells process established by the Commission, the Company has the opportunity to respond in writing to the "Wells Notice" before the staff makes a formal recommendation regarding what action, if any, should be brought against the Company by the Commission. The Company intends to respond promptly and thoroughly. The Company reiterates its intention to cooperate fully with the SEC in the course of its investigation. ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments, designed to address the medical needs of patients with a variety of cancers. The Company's three programs include growth factor blockers, cancer vaccines and angiogenesis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems is headquartered in New York with additional administration and manufacturing facilities in Somerville, New Jersey. -more- ImClone Systems Incorporated Page two The matters discussed in this news release may include forward-looking statements which involve potential risks and uncertainties. Important factors that may cause actual results to differ materially include, but are not limited to, the risks and uncertainties associated with completing preclinical and clinical trials of the Company's compounds that demonstrate such compounds' safety and effectiveness; obtaining additional financing to support the Company's operations; obtaining and maintaining regulatory approval for such compounds and complying with other governmental regulations applicable to the Company's business; obtaining the raw materials necessary in the development of such compounds; consummating collaborative arrangements with corporate partners for product development; achieving milestones under collaborative arrangements with corporate partners; developing the capacity to manufacture, market and sell the Company's products, either directly or with collaborative partners; developing market demand for and acceptance of such products; competing effectively with other pharmaceutical and biotechnological products; obtaining adequate reimbursement from third party payers; attracting and retaining key personnel; obtaining patent protection for discoveries and risks associated with commercial limitations imposed by patents owned or controlled by third parties. The Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. # # # -----END PRIVACY-ENHANCED MESSAGE-----