Sinovac Files Clinical Trial Application with SFDA for Vaccine Against Hand, Foot, and Mouth Disease
BEIJING, Dec. 28 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today that it has filed the application with China's State Food and Drug Administration (SFDA) to commence a human clinical trial for its vaccine against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD). This is the first clinical trial application for HFMD vaccine submitted in China.
No vaccine or antiviral treatment is currently available for HFMD worldwide, though it has become a very serious problem in Asia in recent years. The disease is highly contagious and a growing number of HFMD cases have been reported in parts of Asia, including Mainland China, Hong Kong, Singapore, Korea, and Taiwan. According to China's Center for Disease Control (CDC) between January 1 and November 30 of this year, the disease has caused more than 400 deaths in China, where health authorities reported over 1.1 million HFMD infections, compared to about 200 reported H1N1 deaths. HFMD is common among infants and children, as most of the recently reported cases have occurred in children. Due to the severity of the disease epidemic, China authorities recognize the unmet medical need and are expected to support the launch of a HFMD vaccine as soon as possible. Therefore, Sinovac believes that fast track status for the reviewing process and approval may be granted.
As previously announced, the Company began preclinical development in 2008. Sinovac is independently developing the EV 71 vaccine and will retain full commercialization rights of the vaccine upon approval. Created by Sydney University, the animal model showed cross protection and demonstrated that the vaccine is effective in animals. In addition, Sinovac is preparing to file a patent application covering the EV 71 vaccine.
Weidong Yin, Chairman, President & CEO, stated, "We are very pleased to submit the clinical trial application for the EV 71 vaccine to the SFDA. Our ability to submit the application ahead of the projected 2010 timeline is a validation of the R&D capabilities of the team developing this vaccine. A vaccine against EV 71 represents a significant unmet medical need, given that there are not effective preventive therapeutic alternatives for this life threatening viral illness affecting infants and children. Based on current expectations, we anticipate that the EV 71 vaccine, subject to positive human clinical trial results and commercialization, represents a significant flagship product opportunity for the Company as well as an opportunity to improve the lives of children around the world."
About EV 71
Enterovirus 71, or EV 71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease. EV 71 is a frequent cause of HFMD epidemics associated with neurological disease in a small proportion of cases. A number of outbreaks of EV 71 HFMD in the Asia-Pacific region have been reported since 1997. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), Mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. There is no specific treatment for enterovirus infections and a vaccine is not currently available.
In 2008, 489,073 cases were reported in China with 126 reported fatalities. For the first 11 months of 2009, over 1.1 million cases were reported in China, with over 400 reported fatalities.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's vaccine products include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), and Anflu(R) (influenza). Panflu(R) and PANFLU.1(TM), Sinovac's pandemic influenza vaccine (H5N1) and H1N1 vaccine, have already been approved for government stockpiling. Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, Japanese encephalitis, and human rabies. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccine.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any
forward- looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
For more information, please contact:
Helen G. Yang
Sinovac Biotech Ltd.
Tel: +86-10-8289-0088 x9871