Bristol-Myers Squibb And ImClone Systems Significantly Expand ERBITUX Clinical Development Program

ImClone Systems Incorporated and Bristol-Myers Squibb Company recently announced that the companies have amended the terms of their agreement for the co- development and co-promotion of ERBITUX (Cetuximab) in North America. Under this amendment, the companies have jointly agreed to expand the investment in the ongoing clinical development plan for ERBITUX by up to several hundred million dollars. Development costs, up to a threshold value, will be the sole responsibility of Bristol-Myers Squibb; costs in excess of this threshold will be shared by both companies according to a pre-determined ratio.

With this additional funding, the companies will seek to add numerous Phase II and Phase III clinical trials that will further explore the activity of ERBITUX in a wide variety of therapeutic settings. The companies intend to utilize the results of these studies to support new registrational opportunities for ERBITUX. The comprehensive clinical program will supplement the significant body of clinical data existing for ERBITUX in colorectal and head and neck cancers by exploring 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, Research and Development, Bristol-Myers Squibb. "This plan further demonstrates Bristol-Myers Squibb'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 Bristol- Myers Squibb to benefit both companies' shareholders, and most importantly, cancer patients," stated Alexander J. Denner, Ph.D., Chairman, Executive Committee of ImClone Systems Incorporated. "We are very pleased by this agreement and look forward to the two companies working in harmony."

Jim Cornelius, Chief Executive Officer, Bristol-Myers Squibb, stated, "We value our partnership with ImClone Systems -- and this new agreement confirms our strong commitment to oncology patients and the importance of ERBITUX to our business."

Carl Icahn, Chairman of the Board, ImClone Systems Incorporated, stated, "As the new Chairman, I am happy that Bristol-Myers Squibb and ImClone Systems have come to this very amicable agreement which I have every hope should benefit greatly both parties."

Source:www.pharmaceuticalonline.com