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
Date of Report (Date of earliest event reported):
June 20, 2005
IMCLONE SYSTEMS INCORPORATED
(Exact name of Registrant as Specified in 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, principal executive offices)
(212) 645-1405
(Registrant’s telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
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:
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 announced today that, following discussions with the FDA, the Company intends to submit a supplemental Biologics License Application (sBLA) to seek approval for use of Erbitux® (Cetuximab) in combination with radiation and as a single agent in Squamous Cell Carcinoma of the Head and Neck (SCCHN) in the third 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 Exhibits
| | (c) | EXHIBITS |
| | | |
| | 99.1 | Press release dated June 20, 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 D. Ramanathan |
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| | | | | | | Name: Erik D. Ramanathan |
| | | | | | | Title: Vice President, General Counsel |
Date: June 20, 2005
EXHIBIT INDEX
| Exhibit No. | Description |
| | | | |
| 99.1 | Press Release of ImClone Systems Incorporated dated June 20, 2005 |
Exhibit 99.1
