Genzyme and Sunway to Collaborate on Gene Therapy Program in China

Genzyme Corporation (Cambridge, MA) and Sunway Biotech Company Limited (Shanghai, China) will collaborate to manufacture, develop, and commercialize the experimental gene therapy Ad2/HIF-1a in China. The product is Genzyme’s most advanced gene therapy candidate and is currently in Phase 2 clinical testing at 40 US and European medical centers.

Under the terms of the collaboration, Genzyme will transfer its process for manufacturing Ad2/HIF-1a to Sunway, who will produce the product at its Shanghai facility for clinical trials. Sunway will design, fund, and conduct the Phase 1 and Phase 2 studies in China, focusing on patients with critical limb ischemia, a severe form of peripheral arterial disease that often leads to limb amputation. Genzyme previously completed a Phase 1 study of Ad2/HIF-1a involving patients with critical limb ischemia.

Ad2/HIF-1a is an engineered form of the HIF-1a gene designed to promote the growth of new blood vessels and improve circulation in the limbs of patients with peripheral arterial disease.

Genzyme and Sunway will equally fund a Phase 3 development program, and the companies will jointly commercialize a therapy in China if the development program is successful.

Genzyme release