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."
About Genzyme
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.
About Sunway
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.
Genzyme(R) is a registered trademark of Genzyme Corporation. All rights
reserved.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line at
1-800- 905-4369 within the United States or 1-678-999-4572 outside the
United States.
Media Contact: Investor Contact:
Bo Piela Patrick Flanigan
617-768-6579 617-768-6563
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media: Bo Piela, +1-617-768-6579; or
Investors: Patrick Flanigan, +1-617-768-6563, both of Genzyme
Corp.
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