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INCLONE/UCB TO DEVELOP/COMMERCIALIZE CDP-791.

ImClone Systems Incorporated (NASDAQ: IMCL) and UCB 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, CEO 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.

About UCB

UCB (http:///www.ucb-group.com) is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specializing 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(R) (antiepileptic), Xyzal(R) and Zyrtec(R) (antiallergics), Nootropil(R) (cerebral function regulator), Tussionex(TM) (antitussive) and Metadate(TM) / Equasym XL(TM) (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 EUR 5.8 billion.

For more information, call 646/638-5058 or visit http://www.imclone.com.
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Publication:Worldwide Biotech
Geographic Code:1USA
Date:Oct 1, 2005
Words:512
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