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No vaccine or antiviral treatment is currently available for HFMDworldwide, 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 beenreported 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 morethan 400 deaths in China, where health authorities reported over 1.1 millionHFMD infections, compared to about 200 reported H1N1 deaths. HFMD is commonamong infants and children, as most of the recently reported cases haveoccurred in children. Due to the severity of the disease epidemic, Chinaauthorities recognize the unmet medical need and are expected to support thelaunch of a HFMD vaccine as soon as possible. Therefore, Sinovac believes thatfast track status for the reviewing process and approval may be granted.
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As previously announced, the Company began preclinical development in 2008.Sinovac is independently developing the EV 71 vaccine and will retain fullcommercialization rights of the vaccine upon approval. Created by SydneyUniversity, the animal model showed cross protection and demonstrated that thevaccine is effective in animals. In addition, Sinovac is preparing to file apatent application covering the EV 71 vaccine.
Weidong Yin, Chairman, President & CEO, stated, "We are very pleased tosubmit the clinical trial application for the EV 71 vaccine to the SFDA. Ourability to submit the application ahead of the projected 2010 timeline is avalidation of the R&D capabilities of the team developing this vaccine. Avaccine against EV 71 represents a significant unmet medical need, given thatthere are not effective preventive therapeutic alternatives for this lifethreatening viral illness affecting infants and children. Based on currentexpectations, we anticipate that the EV 71 vaccine, subject to positive humanclinical trial results and commercialization, represents a significantflagship product opportunity for the Company as well as an opportunity toimprove 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 causeof HFMD epidemics associated with neurological disease in a small proportionof cases. A number of outbreaks of EV 71 HFMD in the Asia-Pacific region havebeen 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 specifictreatment 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.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company thatfocuses on the research, development, manufacture and commercialization ofvaccines that protect against human infectious diseases. Sinovac's vaccineproducts include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A andB), and Anflu(R) (influenza). Panflu(R) and PANFLU.1(TM), Sinovac's pandemicinfluenza vaccine (H5N1) and H1N1 vaccine, have already been approved forgovernment stockpiling. Sinovac is developing vaccines for enterovirus 71,universal pandemic influenza, Japanese encephalitis, and human rabies. Itswholly owned subsidiary, Tangshan Yian, is conducting field trials forindependently developed inactivated animal rabies vaccine.
Safe Harbor Statement
This announcement contains forward-looking statements. These statementsare made under the "safe harbor" provisions of the U.S. Private SecuritiesLitigation Reform Act of 1995. These forward-looking statements can beidentified 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 inthis press release contain forward-looking statements. Statements that are nothistorical facts, including statements about Sinovac's beliefs andexpectations, are forward-looking statements. Forward-looking statementsinvolve inherent risks and uncertainties. A number of important factors couldcause actual results to differ materially from those contained in anyforward-looking statement. Sinovac does not undertake any obligation to updateany 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 Fax: +86-10-6296-6910 Email: [email protected] Investors: Amy Glynn/Stephanie Carrington The Ruth Group Tel: +1-646-536-7023/7017 Email: [email protected] [email protected] Media: Janine McCargo The Ruth Group Tel: +1-646-536-7033 Email: [email protected]
SOURCE Sinovac Biotech Ltd.
