-----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, RmixsmhYvovYbdQMivQE+L64rvBXIz7XYzlN7++8RSLcrSlHd2U2GzFOVDZusdg0 bF5O1CL9pJ0euLxFp6XtJA== 0001104659-05-002599.txt : 20050126 0001104659-05-002599.hdr.sgml : 20050126 20050126103155 ACCESSION NUMBER: 0001104659-05-002599 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050126 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050126 DATE AS OF CHANGE: 20050126 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: 05548667 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 a05-2202_38k.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):  January 26, 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 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:

 

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.

 

On January 26, 2005, ImClone Systems Incorporated (the “Company”) announced that it had signed license agreements with Genentech and Centocor Inc. (a Johnson & Johnson company) for the rights to patents covering various aspects of antibody technology (U.S. Patent 4,816,567, U.S. Patent 6,331,415, the Cabilly patents of Genentech; and U.S. Patent 5,807,715, the Morrison patent of Centocor) and certain use of epidermal growth factor receptor antibodies (U.S. Patent 5,770,195, the Hudziak patent of Genentech).

 

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.

 

(c)

Exhibits.

 

 

 

 

 

 

 

Exhibit No.

 

Exhibit Title

 

 

 

 

 

99.1

 

Press release of ImClone Systems Incorporated dated January 26, 2005.

 

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 hereunto duly authorized.

 

 

 

IMCLONE SYSTEMS INCORPORATED

 

 

 

By:

/s/ Erik Ramanathan

 

 

 

Name:

Erik Ramanathan

 

 

Title:

Vice President, Legal
and General Counsel

 

 

 

 

Date:  January 26, 2005

 

 

 

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Exhibit Title

 

 

 

99.1

 

Press release of ImClone Systems Incorporated dated January 26, 2005.

 

4


EX-99.1 2 a05-2202_3ex99d1.htm EX-99.1

EXHIBIT 99.1

 

 

ImClone Systems Incorporated

 

 

Investors:

 

Media:

Andrea F. Rabney

 

David M. F. Pitts

(646) 638-5058

 

(646) 638-5058

Stefania Bethlen

 

 

(646) 638-5058

 

 

 

IMCLONE SYSTEMS SIGNS LICENSE AGREEMENTS WITH GENENTECH AND
CENTOCOR FOR PATENT RIGHTS RELATING TO ANTIBODIES TARGETING
THE EPIDERMAL GROWTH FACTOR RECEPTOR

 

New York, NY, January 26, 2005 – ImClone Systems Incorporated (NASDAQ: IMCL) announced today that it has signed license agreements with Genentech (NYSE: DNA) and Centocor Inc. (a Johnson & Johnson Company) for the rights to patents covering various aspects of antibody technology (U.S. Patent 4,816,567, U.S. Patent 6,331,415, the Cabilly patents of Genentech; and U.S. Patent 5,807,715, the Morrison patent of Centocor) and certain use of epidermal growth factor receptor (EGFR) antibodies (U.S. Patent 5,770,195, the Hudziak patent of Genentech).

 

These licenses relate to Erbitux®, an IgG1 monoclonal antibody approved for use in irinotecan resistant or refractory, EGFR-expressing metastatic colorectal cancer, and IMC-11F8, an investigational fully-human EGFR-targeted antibody currently in Phase I clinical testing.

 

For Erbitux use in combination with anti-neoplastic agents, ImClone Systems’ gross royalty expense for all licenses, including Genentech, Centocor, Aventis and the University of California, is approximately 12.75 percent of North American sales and is effective from February 24, 2004. ImClone Systems receives reimbursements for a portion of these royalty expenses, resulting in a net royalty expense to ImClone Systems of 8.25 percent. After the first quarter of 2006, gross royalty expense will decrease to 9.75 percent and net royalty expense will decrease to 7.25 percent. For Erbitux monotherapy use, gross and net royalty expenses will be reduced because certain licenses are not applicable. As a condition of these agreements, certain terms, including enumerated royalty payments, will not be publicized. Fourth-quarter 2004 royalty expenses include adjustments required to bring estimated royalty expenses through the first nine months of the year in line with actual obligations.

 



 

For sales outside of North America, of Erbitux manufactured in the U.S., such expenses will be passed through to ImClone Systems’ partner Merck KGaA as a component of cost of goods for commercial product.

 

“We are pleased to have concluded these negotiations and to be in a position to give greater clarity to our investors with regard to our Erbitux royalty expenses,” stated Daniel S. Lynch, Chief Executive Officer of ImClone Systems.

 

About ImClone Systems Incorporated

 

ImClone Systems Incorporated is committed to advancing oncology care by developing and commercializing 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, angiogenesis inhibitors and cancer vaccines. ImClone Systems’ strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

 

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company’s ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company’s filings with the Securities and Exchange Commission including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

 

# # #

 


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