Sinovac Biotech Ltd. To Test Fully Human Antibody Developed By Medarex, Inc. And Massachusetts Biologic Laboratories For Its Ability To Neutralize The SARS Virus
BEIJING--(BUSINESS WIRE)--April 26, 2004--Sinovac Biotech Ltd. ("Sinovac") (OTCBB:SNVBF) (Frankfurt:SVQ) is pleased to announce that it has entered into an agreement to conduct pre-clinical testing of a SARS antibody that has been jointly developed by Medarex, Inc. (NASDAQ:MEDX) and the Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS).
A sample of the fully human SARS antibody has been sent to Sinovac for testing against SARS strains used for Sinovac's investigational vaccine and the control strain from previous cases in China.
Reacting quickly to contain the recent outbreak of SARS, and to speed research on potential SARS therapies, Sinovac submitted this idea to the Chinese State Food and Drug Administration and received support to test the Medarex/MBL/UMMS antibody before any further action.
Sinovac plans to conduct preclinical tests to determine the antibody's effectiveness in neutralizing the strains of the virus.
On the 9th October 2003, Medarex/MBL announced they had neutralized the SARS virus in non-human tissue cultures. The breakthrough was accomplished using antibodies from genetically engineered mice immunized with a protein the SARS virus uses to infect cells. Researchers believe this advance may lead to treatments to prevent infection with SARS after individuals have been exposed to the virus, and potentially to therapeutic products to treat those already infected. Thus, these antibodies are potential therapeutics unlike Sinovac's proprietary SARS vaccine - which is intended to treat against infection by the SARS virus.
"When faced with an outbreak of a deadly infectious disease like SARS, those with a public health mission need to move fast," said Donna Ambrosino, MD, Director of the MBL and a Professor of Pediatrics at UMass Medical School. "When the request was made to us, we were able to ship the antibody within hours."
The antibody developed by MBL and Medarex is the result of an accelerated research effort funded by the National Institutes of Health that was launched in April of 2003 following the first global outbreak of SARS. To date, the antibody developed by MBL and Medarex has shown great promise in laboratory tests in the United States.
As previously announced, MBL partnered with Medarex to use Medarex's UltiMAb(TM) technology to generate fully human antibodies with the potential to treat SARS. Under the terms of that agreement, Medarex and MBL expect to share equally the full development costs of any antibody products as well as any future revenues arising from these products.
UMMS/Medarex have agreed to negotiate with Sinovac in good faith with respect to their respective ownership of Sinovac's research results and any intellectual property rights therein obtained.
"We are hopeful that our fully human antibody technology can be useful to Sinovac in addressing this important public health issue," said Donald L. Drakeman, President and CEO of Medarex, Inc.
Further information can be found on the collaboration between Medarex and the Massachussetts Biological Laboratories (MBL) in Medarex's news releases at www.medarex.com: "Potential SARS Treatment to be Developed by Medarex and Massachussets Biological Laboratories" dated 25th April 2003; and "Researchers Neutralize SARS Virus in Lab Tests" dated 9th October 2003.
SARS, a viral respiratory illness caused by a coronavirus, was first reported in Asia in February 2003, and over the following few months, the illness spread to more than two dozen countries in North America, South America, Europe, and Asia. According to the World Health Organization, during the SARS outbreak of 2003, a total of 8,098 people worldwide became sick with SARS; of these, 774 died. The SARS global outbreak of 2003 was contained; however, it is expected that the disease could re-emerge in an annual cycle similar to the common flu.
About University of Massachusetts Medical School
The University of Massachusetts Medical School is one of the fastest growing academic health centers in the country and has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $153 million in extramural research funding annually, 80 percent of which comes from federal funding sources. Research dollars enable UMMS scientists to explore human disease from the molecular level to large-scale clinical trials. Basic and clinical research leads to new approaches for diagnosis, treatment and prevention of disease. Visit www.umassmed.edu for additional information.
About Massachusetts Biologic Laboratories
The Massachusetts Biologic Laboratories is the only non-profit FDA-licensed manufacturer of vaccines and other biologic products in the United States. The laboratory was established in 1894; since then, the MBL's mission has been to improve public health through applied research, development and production of biologic products. MBL has been a part of the UMass Medical School since 1997.
Medarex (Nasdaq: MEDX) is a biopharmaceutical company focused on the discovery and development of therapeutics to treat life-threatening and debilitating diseases. Medarex's UltiMAb Human Antibody Development System(R) is a unique combination of human antibody technologies that Medarex believes enables the rapid creation and development of fully human antibodies to a wide range of potential disease targets for therapeutic antibody products, including products for the treatment of cancer, inflammation, autoimmune and infectious diseases. Medarex's product pipeline is based on a variety of therapeutic antibody products developed through the use of its UltiMAb(TM) technology. Medarex creates and develops fully human antibodies for itself and others, offering a full range of antibody related capabilities, including pre-clinical and clinical development supported by cGMP manufacturing services. For more information about Medarex, visit its website at www.medarex.com.
About Sinovac Biotech Ltd.
Sinovac Biotech Ltd. specializes in the research, development, commercialization, and sales of human vaccines for infectious illnesses such as Hepatitis A and Hepatitis B, influenza and "SARS." Sinovac is one of the leading emerging biotechnology companies in China. Working closely with Chinese public health officials, Sinovac focuses on manufacturing and marketing human-use vaccines and related products, and currently markets its vaccine for Hepatitis A. Sinovac is the first and currently the only company in the world to have been granted permission to begin clinical trials for a vaccine to prevent SARS.
For further information please refer to the Company's filings with the SEC on EDGAR or refer to Sinovac's website at www.sinovac.com.
MANAGEMENT OF SINOVAC WHO TAKE FULL RESPONSIBILITY FOR ITS CONTENTS HAS PREPARED THIS NEWS RELEASE. THIS NEWS RELEASE MAY INCLUDE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED, AND SECTION 21E OF THE UNITED STATES SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED, WITH RESPECT TO ACHIEVING CORPORATE OBJECTIVES, DEVELOPING ADDITIONAL PROJECT INTERESTS, SINOVAC'S ANALYSIS OF OPPORTUNITIES IN THE ACQUISITION AND DEVELOPMENT OF VARIOUS PROJECT INTERESTS AND CERTAIN OTHER MATTERS. THESE STATEMENTS ARE MADE UNDER THE "SAFE HARBOR" PROVISIONS OF THE UNITED STATES PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 AND INVOLVE RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE IN THE FORWARD-LOOKING STATEMENTS CONTAINED HEREIN. THIS NEWS RELEASE SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES IN ANY JURISDICTION IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH JURISDICTION.
Sinovac Biotech Ltd.
Investor Relations 1-888-888-8312 or (604) 684-5990 Website: www.sinovac.com