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Eli Lilly & Company

Drug Names(s): cetuximab, IMC-C225

Description: Erbitux, a chimeric monoclonal antibody, binds specifically to epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor [EGF] and other ligands, such as transforming growth factor-alpha. Binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. The EGFR is constitutively expressed in many normal epithelial tissues, including the skin and hair follicle. Over-expression of EGFR is also detected in many human cancers including those of the colon and rectum.

Deal Structure: ImClone and Merck KGaA
In December 1998, ImClone entered into an agreement with Merck KGaA relating to the development and commercialization of Erbitux. Under this agreement, ImClone granted Merck exclusive rights to market Erbitux outside of North America and will co-develop Erbitux in Japan with Merck. In return, Merck is paying ImClone $30 million in upfront fees and early cash-based milestone payments and will pay an additional $30 million assuming ImClone achieves further milestones for which Merck will receive equity in ImClone. Merck will fund clinical development of Erbitux outside of North America and is required to pay ImClone royalties on future sales of Erbitux outside of North America, if any.

Royalty revenue from Merck KGaA was in the range of 4-4.5% for 2004 and the first half of 2005, until such time as a contractual minimum of cumulative sales are reached. After such time (mid-2005), the royalty rate increases to 7-7.5%. ImClone also receives...See full deal structure in Biomedtracker

Partners: Bristol-Myers Squibb Company Merck KGaA Sanofi Yeda R&D Company

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