Bristol-Myers, ImClone expand Erbitux development program

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 the drug in a wide variety of therapeutic settings. The companies say they intend to use the results of these studies to support new registrational opportunities for Erbitux.

The clinical program will supplement the significant body of clinical data existing for Erbitux in colorectal and head and neck cancers by exploring its use in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate.

“By broadening the drug’s 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, executive vice president, chief scientific officer and president of R&D for Bristol-Myers Squibb.