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 15, 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

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 1.01.  Entry into a Material Definitive Agreement

On August 15, 2005, ImClone Systems Incorporated (the “Company”) entered into a Collaboration and License Agreement with UCB S.A., a company registered in Belgium (the “Agreement”) for the development and commercialization of CDP-791, UCB’s novel, investigational PEGylated diFab antibody targeting the vascular endothelial growth factor receptor-2 (“VEGFR-2”).  The press release announcing the transaction is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

No upfront or milestone payments are payable under the Agreement.  The Agreement provides that the Company and UCB will share equally all agreed upon development costs for CDP-791 as well as worldwide profits derived from the commercialization of CDP-791 in indications jointly pursued by the parties.  The Company will also receive an incremental single-digit royalty on net sales worldwide for such indications.  Under certain circumstances, one party may be entitled to pursue (in its territory) an indication independently of the other party, which retains the option to join in the development or commercialization at a later stage.  The Company has exclusive commercialization rights to CDP-791 in North America, with UCB receiving such rights in Europe, Japan, and the rest of the world.

UCB’s Phase II proof of concept study in non-small cell lung cancer is scheduled to start in the next few weeks, with results anticipated by the end of next year.  The Company and UCB plan to pursue a Phase II study in renal cancer and are evaluating clinical trials in other indications, including ovarian and colorectal cancers.  For the balance of the year, the Company anticipates an increase in clinical development expenses by $3 million to $5 million as a result of spending on clinical trials related to CDP-791, or an expected clinical and regulatory expense of approximately $48 million to $50 million for the full year 2005.

The Company is currently developing its own anti-VEGFR-2 antibody known as IMC-1121B and plans to continue developing this antibody – currently in Phase I testing – through Phase II testing in parallel with the development of CDP-791.  If within a period of approximately five years the Company determines that IMC-1121B is more commercially viable, the Company may opt-out of the CDP-791 partnership at no additional cost, in which case the Company would be entitled to receive a royalty under certain circumstances.

Certain matters discussed in this report 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 report 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 report, 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.

Item 8.01.  Other Events

On August 15, 2005, ImClone Systems Incorporated issued a press release, attached as Exhibit 99.1 and incorporated herein by reference, announcing its entry into a material definitive agreement, as described in greater detail in Item 1.01 hereof.

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Item 9.01.  Financial Statements and Exhibits

(c) Exhibits

Exhibit No.	Description of Exhibit
99.1	Press Release dated August 15, 2005.

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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 , General Counsel

Date:  August 16, 2005

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EXHIBIT INDEX

Exhibit No.	Description of Exhibit
99.1	Press Release dated August 15, 2005.

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EX-99.1

Exhibit 99.1

NOT FOR IMMEDIATE RELEASE

IMCLONE SYSTEMS AND UCB ENTER INTO WORLDWIDE PARTNERSHIP
FOR CDP-791, A NOVEL INVESTIGATIONAL THERAPY TARGETING THE DEVELOPMENT OF TUMOR VASCULATURE

Novel Antibody Targeting the VEGF Receptor-2 to Enter Phase II Clinical Development

New York and Brussels – August 15, 2005 – ImClone Systems Incorporated (NASDAQ: IMCL) and UCB announced today that they have entered into a worldwide strategic partnership for the development and commercialization of CDP-791, a novel, investigational antibody targeting the vascular endothelial growth factor receptor-2 (VEGFR-2) that is currently being developed by UCB.  VEGFR-2 is known to regulate the formation of blood vessels in tumors (angiogenesis), allowing cancer cells to receive nutrients and maintain growth.  CDP-791 takes the novel approach of targeting and blocking VEGFR-2 on blood vessel cells with a PEGylated diFab antibody and thus interferes with the development of tumor vasculature.  This mechanism has been shown to interfere with tumor vasculature in preclinical models.

CDP-791 completed Phase I testing earlier in 2005 in patients with refractory solid tumors.  The study comprised six ascending dose groups each given CDP-791 intravenously once every three weeks.  The study results showed that CDP-791 was well tolerated and met its safety endpoint at all dose levels.  No dose-limiting toxicity or signs of immunogenicity were detected.  A randomized Phase II study in non-small cell lung cancer is scheduled to start in the coming weeks.

“VEGF is an important and increasingly recognized pathway in the treatment of solid tumors,” stated Daniel S. Lynch, Chief Executive Officer of ImClone Systems. “Our partnership with UCB gives us the opportunity to collaborate on a product that significantly accelerates our anti-VEGFR-2 program and potential commercial entry into the anti-angiogenesis space at terms that are economically attractive to both partners.  We look forward to working with UCB and to CDP-791’s prospects for clinical and commercial success.”

Under terms of the agreement, UCB and ImClone Systems will share equally all agreed upon development costs for CDP-791 as well as worldwide profits derived from its commercialization in indications jointly pursued by the parties.  ImClone Systems will also receive an incremental single-digit royalty on net worldwide sales for such labeled indications.  ImClone Systems has exclusive commercialization rights to CDP-791 in North America, with UCB receiving such rights in Europe, Japan, and the rest of the world.

“We are delighted to be collaborating with ImClone Systems on our exciting CDP-791 program. ImClone Systems’ considerable expertise in VEGF biology combined with the antibody fragment expertise from UCB’s Celltech Antibody Centre of Excellence will form a powerful partnership.  Both of our companies share a commitment to improving the treatment and survival of cancer patients. This is an important milestone in the building of UCB’s oncology franchise,” stated Melanie Lee, Executive Vice President R & D for UCB.

Conference Call

ImClone Systems and UCB will host a joint conference call with the financial community to discuss their partnership, tomorrow, August 16, 2005 at 9:00 AM U.S. Eastern Daylight Time (2:00 PM Greenwich Mean Time). The conference call will be webcast live and may be accessed by visiting ImClone Systems’ website at www.imclone.com.

Those parties interested in participating via telephone may join by dialing (888) 694-4641 within the United States or Canada, or 001 973-935-8512 for calls outside of Canada and the United States, and request conference number 6339387. A telephone replay of the conference call will be available shortly after the call until August 23, 2005. To access the telephone replay, dial (877) 519-4471 in the United States or Canada, or 001 973-341-3080 for calls outside of Canada and the United States, and enter passcode number 6339387.

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 research and development programs include growth factor blockers 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’ 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.

About UCB

UCB - www.ucb-group.com - is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specialising in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders, as well as oncology. UCB key products are Keppra® (antiepileptic), Xyzal® and Zyrtec® (antiallergics), Nootropil® (cerebral function regulator), Tussionex™ (antitussive) and Metadate™ / Equasym XL™ (attention-deficit/hyperactivity disorder). UCB employs over 8,500 people operating in over 40 countries. UCB is listed on Euronext Brussels with a market capitalization of approximately € 5.8 billion.

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Media and Investor Contacts:

Andrea Rabney Corporate Communications ImClone Systems Incorporated Tel: (646) 638-5058 Andrea.Rabney@imclone.com	Jean-Christophe Donck Corporate Communications and Investor Relations UCB Tel.: +32 (0) 2 559 9588 JC.Donck@UCB-Group.com
or
David Pitts Corporate Communications ImClone Systems Incorporated Tel: (646) 638-5058 David.Pitts@imclone.com
or
Stefania Bethlen Corporate Communications/IR ImClone Systems Incorporated Tel: (646) 638-5058 Stefania.Bethlen@imclone.com