CAMBRIDGE, Mass., and SHANGHAI, China /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) and Sunway Biotech Co. Ltd. announced today that they 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 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 commercialize 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.
A Phase 3 development program would be funded equally by Genzyme and Sunway, and the companies envision jointly commercializing a therapy in China if the development program is successful.
"We are pleased to establish this relationship with Sunway, one of the most innovative young biotechnology companies in China," said Genzyme Executive Vice President Duke Collier. "Our work with Sunway represents one of many ways that we hope to participate in the dynamic Chinese biotechnology industry and to contribute to its growth."
Hu Fang, M.D., Sunway's chief executive officer, added: "We are eager to begin working with Genzyme, one of the established leaders in the field of gene therapy. This collaboration allows us to expand our focus beyond oncology to include cardiovascular disease, another area of serious unmet medical need where innovative therapies are urgently needed."
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with nearly 10,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
Sunway Biotech Co. Ltd. is a leading Chinese biopharmaceutical company that develops, manufactures and commercializes biotherapeutics primarily for the Chinese market. With expertise in all aspects of development and commercialization, Sunway is able to serve as a key partner to leading western bio-pharmaceutical looking to China for clinical trials, manufacturing and/or sales. With a population exceeding 1.3 Billion and rapid growth in personal income, China is still a largely untapped pharmaceutical market. Sunway, through its partnership model and extensive network, is capitalizing on this opportunity. Sunway is currently in the process of closing an investment round to support its rapidly growing operations.
This press release contains forward-looking statements, including statements about Genzyme's and Sunway's intention to conduct clinical trials of, and ultimately commercialize HIF-1a in China. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: Genzyme's and Sunway's ability to transfer the process for manufacturing HIF-1a from Genzyme to Sunway, the extent to which HIF-1a is ultimately demonstrated to be safe and effective, Sunway's ability to manufacture sufficient product supply and to distribute the product in a timely and effective manner to support the necessary clinical trials and commercialization, the ability to obtain marketing approval within the territory, the size of the market in the territory for the therapy, actions by governmental authorities related to HIF-1a, and the other risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending June 30, 2007. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.
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