Sinovac Files Clinical Trial Application with SFDA for Vaccine Against Hand, Foot, and Mouth Disease
December 28 2009 - 7:00AM
PR Newswire (US)
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. About Sinovac 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 Fax: +86-10-6296-6910 Email: Investors: Amy
Glynn/Stephanie Carrington The Ruth Group Tel: +1-646-536-7023/7017
Email: Media: Janine McCargo The Ruth Group Tel: +1-646-536-7033
Email: DATASOURCE: Sinovac Biotech Ltd. CONTACT: Helen G. Yang of
Sinovac Biotech Ltd., +86-10-8289-0088 x9871, fax +86-10-6296-6910,
; or Investors, Amy Glynn, +1-646-536-7023, , or Stephanie
Carrington, +1-646-536-7017, , or Media, Janine McCargo,
+1-646-536-7033, , all of The Ruth Group
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