Sunway will be responsible for initial clinical evaluation, while both companies will share Phase III development funding and final commercialization.
Sunway Biotech will collaborate on the manufacture, development, and commercialization of Genzyme’s gene therapy in China. Ad2/HIF-1a is an engineered form of the HIF-1a gene, which is designed to promote the growth of new blood vessels and improve circulation in the limbs of patients with peripheral arterial disease.
Ad2/HIF-1a is currently in Phase II testing in the U.S. and Europe. Genzyme is investigating the safety and effectiveness of locally delivering this therapy to benefit patients with intermittent claudication, a form of peripheral arterial disease that results in disabling pain or fatigue in the legs that is brought on by exercise.
Genzyme will transfer its process for manufacturing to Sunway, which will produce the product at its Shanghai facility for clinical trials. Sunway will design, fund, and conduct Phase I and Phase II studies in China, focusing on patients with critical limb ischemia. Genzyme reports that it previously completed a Phase I study of Ad2/HIF-1a involving patients with critical limb ischemia.
A Phase III development program would be funded equally by Genzyme and Sunway. The companies expect to jointly commercialize the therapy in China.