8-K 1 a07-22613_28k.htm 8-K

 

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): August 20, 2007

 

IMCLONE SYSTEMS INCORPORATED

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

0-19612

 

04-2834797

(State or other jurisdiction of Incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

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)

 

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 (see General Instruction A.2. below):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

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 (the “Company”) issued a press release on August 20, 2007 announcing that it has received approval from the Food and Drug Administration for its second facility to manufacture ERBITUX®.  The approval to manufacture ERBITUX in the Company’s new 250,000-square-foot multi-suite manufacturing facility, referred to as “BB50”, more than doubles the Company’s total available production volume capacity for ERBITUX.  This approval, in conjunction with the Company’s existing “BB36” manufacturing facility, enhances the Company’s ability to meet increasing demand for ERBITUX in the worldwide market.

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.

(d) Exhibits

Exhibit No.

 

Description

 

 

 

 

99.1

 

Press Release of ImClone Systems Incorporated dated August 20, 2007.

 

 




 

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 hereunto duly authorized.

 

IMCLONE SYSTEMS INCORPORATED

 

(Registrant)

 

 

 

 Dated: August 24, 2007

By:

 /s/ Daniel J. O’Connor

 

 

Daniel J. O’Connor

 

 

Senior Vice President and General Counsel