Genzyme to collaborate with China''s Sunway Biotech on gene therapy programme in China

Biotechnology major Genzyme Corp and Chinese biopharmaceutical company Sunway Biotech Co. Ltd that develops, manufactures and commercializes biotherapeutics primarily for the Chinese market, have announced that they will collaborate to manufacture, develop, and commercialise 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 in the United States and Europe.

Sunway is a privately-held, Shanghai-based biotechnology company founded in 1995. It is one of only two companies in the world to have successfully developed and commercialized a gene therapy product. Sunway''s H101, an adenovirus agent for the treatment of head and neck cancer, was approved in China in 2005.

With strong technical, regulatory, manufacturing and clinical expertise, Sunway is working towards becoming a preferred partner to western biopharmaceutical firms looking to develop and commercialise products in China.

Genzyme has been a gene therapy pioneer, and the company''s commitment to the field remains strong, with a broad clinical and pre-clinical research program in the areas of cardiovascular disease, Parkinson''s disease and other neurodegenerative diseases, ocular disease, and lysosomal storage disorders. Additionally, Genzyme has a gene therapy manufacturing facility in San Diego, California.

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 is currently conducting a Phase 2 clinical trial of Ad2/HIF-1a involving more than 300 patients at 40 U.S. and European medical centers. The trial is examining the safety and effectiveness of locally delivered Ad2/HIF-1a to benefit patients with intermittent claudication, a form of peripheral arterial disease that results in disabling pain or fatigue in the legs, brought on by exercise.

Under the collaboration with Sunway, 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 Phase 1 and Phase 2 studies in China, focusing on patients with critical limb ischemia, a more severe form of peripheral arterial disease that often leads to the need for limb amputation. Genzyme previously completed a Phase 1 study of Ad2 / HIF-1a involving patients with critical limb ischemia.