ImClone Systems and Bristol-Myers Squibb have amended the terms of their Erbitux agreement regarding the development and promotion in North America. Under this amendment, the companies have expanded the investment in the ongoing clinical development program for Erbitux by as much as several hundred million dollars. BMS will be responsible for development costs up to a threshold value. The companies will share costs beyond this threshold.

The companies added Phase II and Phase III trials to further explore the activity of Erbitux in a variety of therapeutic settings. The results of these studies will be used to support new registrational opportunities for the drug. The clinical program will supplement the existing data for Erbitux in colorectal and head and neck cancers and explore the use of Erbitux in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate.

"By broadening the Erbitux development program with ImClone Systems and utilizing pharmacogenomic markers and other screening technologies, we intend to enhance cancer patient outcomes which may further differentiate Erbitux from other commercially available antibodies," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, R&D, BMS. "This plan further demonstrates BMS's focus on the development of innovative compounds, like Erbitux, and highlights our company's dedication to partnerships that can maximize the potential of products in our portfolio."

"This new commitment to Erbitux represents one of the largest and broadest cancer-focused development programs for any antibody. The agreement aligns the development and commercialization of Erbitux at ImClone Systems and BMS to benefit both companies' shareholders, and most importantly, cancer patients," stated Alexander J. Denner, Ph.D., chairman, executive committee of ImClone Systems. "We are very pleased by this agreement and look forward to the two companies working in harmony."

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