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):
April 12, 2005
IMCLONE SYSTEMS INCORPORATED
(Exact Name of Registrant as Specified in Its Charter)
| Delaware | 0-19612 | 04-2834797 |
| (State of incorporation or organization) | (Commission File Number) | (I.R.S. Employer 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
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| | o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| | o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| | o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| | o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events
ImClone Systems Incorporated and Bristol-Myers Squibb Company announced today that they intend to file a supplemental Biologics License Application (sBLA) to seek approval of Erbitux® (Cetuximab) for use as a single agent and in combination with radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) with the U.S. Food and Drug Administration (FDA) before the end of the year. The Companies had previously announced they intended to submit an sBLA in the second quarter of 2005.
The text of this press release, which is attached as Exhibit 99.1, is incorporated by reference herein in its entirety.
| Item 9.01 Financial Statements and Exhibits |
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| (c) EXHIBITS |
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| 99.1 Press Release dated April 12, 2005 |
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/ Erik Ramanathan |
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| | Name: | Erik Ramanathan |
| | Title: | Vice President, General Counsel |
Date: April 12, 2005
EXHIBIT INDEX
| Exhibit No. | | Description |
| | | |
| 99.1 | | Press Release dated April 12, 2005 |
