The collaboration provides Genzyme with exclusive worldwide rights to mipomersen, a novel lipid-lowering drug discovered and developed by Isis that is in Phase III clinical development. During the second half of 2008, enrollment is expected to be completed in a pivotal study of mipomersen in homozygous familial hypercholesterolemia, and a new trial in apheresis-eligible patients is expected to begin.
As part of the agreement, Isis will receive a $175 million license fee for mipomersen. In February 2008, Isis received a $150 million payment from Genzyme to purchase five million shares of Isis common stock at $30 per share.
The companies have updated the deal terms so that Isis will contribute up to $50 million in additional development funding for mipomersen, bringing Isis’s development funding commitment up to $125 million.
Thereafter Isis and Genzyme will share development costs equally. The initial Isis development funding commitment and the shared funding will end when the program is profitable. In exchange for this additional contribution, Isis has the opportunity to receive $75 million in milestone payments early.
Henri Termeer, chairman and CEO of Genzyme, said: “Mipomersen is an innovative treatment that has the potential to change the standard of care for severely ill patients whose needs cannot be addressed by current cholesterol-lowering therapies.”