Bristol-Myers Squibb Company and Corgentech Inc have entered into an agreement to jointly develop and commercialize Corgentech's E2F Decoy (edifoligide sodium), a first-of-its-kind E2F Decoy treatment currently in Phase III development for the prevention of vein graft failure following coronary artery bypass graft (CABG) and peripheral artery (i.e. leg) bypass graft surgery.
"Corgentech has chosen Bristol-Myers Squibb as our partner in developing E2F Decoy based on the company's broad expertise in the cardiovascular field," said John P. McLaughlin, president and chief executive officer, Corgentech. "We look forward to working with Bristol-Myers Squibb to develop and commercialize this product in order to potentially improve the lives of more than one million patients worldwide who undergo vascular bypass surgery each year."
Under terms of the deal, Bristol-Myers Squibb will make an initial payment to Corgentech of $45 million comprising cash and an equity investment in Corgentech, with the potential for an additional $205 million in clinical and regulatory milestone payments. Bristol-Myers Squibb and Corgentech will share development costs in the U.S. and Europe going forward based on a pre-agreed percentage allocation. In the United States, the parties will co-promote E2F Decoy and share profits. Bristol-Myers Squibb has exclusive rights in all other countries and will pay Corgentech a royalty on its sales. Bristol-Myers Squibb may make additional milestone payments based on the achievement of certain sales levels.
E2F Decoy is an oligonucleotide that works by helping the walls of a grafted vein to strengthen over time, which helps the vein to maintain healthy blood flow. During surgery, E2F Decoy is applied to vein grafts ex vivo (outside the body).
E2F Decoy is currently being evaluated in two Phase III clinical trials. The peripheral artery bypass study, known as PREVENT 3, is testing E2F Decoy in 1,400 patients who have undergone peripheral artery bypass surgery at approximately 80 medical centers throughout the U.S. A second study, PREVENT 4, is evaluating the therapy in 2,400 patients who have undergone CABG surgery at more than 100 U.S. medical centers. Enrollment for both studies has been completed. The FDA has granted E2F Decoy Fast Track status for both coronary and peripheral indications due to the important unmet medical needs the product may address.