BEIJING, Feb. 26, 2014 /PRNewswire/ -- Sinovac
Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical
products in China, announced today
that Phase III clinical trial results for its proprietary
Enterovirus 71 ("EV71") vaccine have been published online in the
February 27th issue of
The New England Journal of Medicine ("NEJM"). The
clinical results showed the efficacy of the vaccine against
EV71-associated hand, foot and mouth disease ("HFMD"), or
herpangina, was 94.8% among infants and young children and an
anti-EV71 neutralizing antibody titer of 1:16 was associated with
protection against EV71 associated HFMD or herpangina. As outlined
in the NEJM article, Sinovac's vaccine also demonstrated a 100%
efficacy rate against EV71-associated hospitalization and against
HFMD with neurologic complications, the main cause of
fatalities.
The article, entitled "Efficacy, Safety, and
Immunogenicity of an Enterovirus 71 Vaccine in China," chronicles the
results of the Phase III clinical trial on 10,077 healthy infants
and young children in China (6 to
35 months of age) with a randomized, double-blind,
placebo-controlled, multicenter trial method. The subjects were
randomly assigned in a 1:1 ratio to receive two intramuscular doses
of either Sinovac's EV71 vaccine or placebo, 28 days apart. The
surveillance period was 12 months. The primary endpoint was the
occurrence of EV71-associated HFMD, or herpangina. The results
showed the vaccine can provide protection against EV71 associated
HFMD in infants and children.
According to the statistics from National Health and Family
Planning Commission of China from
2008 to 2013, more than 9 million total cases of HFMD were
reported, resulting in around 2,700 reported fatalities in
China. According to an
epidemiological study for the period of 2008 to 2012, around 80% of
the severe cases and over 90% of fatal cases were caused by the
enterovirus 71 (or EV71 ) infection.
Fengcai Zhu, M.D., Director of Jiangsu Centers for Disease
Control and Prevention, co-principal investigator and lead author,
said, "This study showed that the EV71 vaccine provides protection
to the infants and young children against EV71-associated HFMD and
the vaccine candidate has good safety and immunogenicity profile.
HFMD has been an increasingly important public health issue among
the young children in Asia-Pacific
region, including China, and
caused a significant social burden. The successful development of
the EV71 vaccine is an exciting achievement by Sinovac, as it will
provide an effective tool to protect infants and young children
against EV71 associated HFMD, especially at the level of severe
cases and potential fatalities."
Mr. Weidong Yin, Chairman,
President and CEO commented, "The peer-reviewed publication in NEJM
of our Phase III clinical trial results shows that our scientific
contribution is acknowledged by the academia. The follow-up
research is still ongoing. As there is no commercialized vaccine
and no EV71 specific treatment available, there are increasing
unmet medical needs. We are pleased to see that our vaccine is able
to provide protection to infants and children against the
EV71-associated HMFD. Sinovac is well prepared for the
commercialization of this much needed vaccine. Once the regulatory
approval is granted, we will be able to contribute to the overall
control and prevention of this devastating disease."
About EV71 and HFMD
Enterovirus 71, or EV71, 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. However, there has been an increase in severe HFMD cases
reported associated with neurological symptoms caused by EV71. A
growing number of outbreaks of EV71 HFMD have been reported since
1997 across the Asia-Pacific
region, including mainland China,
Hong Kong, Singapore, South
Korea, and Taiwan.
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. No specific treatment for this enterovirus infection and no
vaccine are currently available.
In China, HFMD has become a
very serious problem, especially in children, given that no vaccine
and specific treatment is currently available to protect against
this disease. In March 2008, an EV71
outbreak in Fuyang City of China's Anhui
Province caused 23 fatalities, and attracted significant
attention from the government and medical communities. In
May 2008, the Chinese Ministry of
Health identified EV71 as a Class C infectious disease according to
prevention and control regulations. EV71 outbreaks have increased
over the last five years, with more than 1 million cases identified
and 500 to 900 reported fatalities each year. According to the
statistics from National Health and Family Planning Commission of
China from 2008 to 2013, more than
9 million cases of HFMD have been reported, resulting in around
2,700 fatalities.
About Sinovac's EV71 Vaccine
Sinovac Biotech Ltd. commenced research and development for its
independently developed EV71 vaccine in 2008. In December of 2009,
Sinovac completed pre-clinical research and filed a clinical trial
application to China Food and Drug Administration (CFDA) and in
December 2010, received CFDA's
approval to assess safety and immunogenicity in Phase I and II
clinical trials, and to conduct an efficacy study in a Phase III
clinical trial. In 2011, Sinovac conducted and completed Phase I
and II clinical trials. The results demonstrated that Sinovac's
EV71 vaccine has a good safety and immunogenicity profile, which
was the basis for the recently concluded Phase III clinical trial
for efficacy in the beginning of 2012. The phase I clinical result
was published by the peer-reviewed journal Vaccine in
March of 2012. The phase II clinical results were published by
"The Journal of Infectious Diseases" in 2013. And
also in 2013, the results on immunogenicity, safety and lot
consistency study in phase III clinical trial were published in
"Clinical and Vaccine Immunology."
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that
focuses on the research, development, manufacturing and
commercialization of vaccines that protect against human infectious
diseases including hepatitis A and B, seasonal influenza, H5N1
pandemic influenza (avian flu), H1N1 influenza (swine flu) and
mumps, as well as animal rabies vaccine for canines. The Company
recently concluded the phase III clinical trial for enterovirus 71
(against hand, foot and mouth disease) and filed new drug
application with China Food & Drug Administration. In 2009,
Sinovac was the first company worldwide to receive approval for its
H1N1 influenza vaccine, Panflu.1, and has manufactured it for the
Chinese Central Government, pursuant to the government-stockpiling
program. The Company is also the only supplier of the H5N1
pandemic influenza vaccine to the government-stockpiling program.
Sinovac is developing a number of new pipeline vaccines including
vaccines for pneumococcal polysaccharides, pneumococcal conjugate,
varicella and rubella. Sinovac sells its vaccines mainly in
China and exports selected
vaccines to Mongolia, Nepal, and the
Philippines. Sinovac has also been granted a license to
commercialize seasonal flu vaccine in Mexico.
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.
Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Tel: +86-10-8279-9659/9696
Fax: +86-10-6296-6910
Email: ir@sinovac.com
Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: scarrington@theruthgroup.com
Media:
Aaron Estrada
The Ruth Group
Tel: +1-646-536-7028
Email: aestrada@theruthgroup.com
SOURCE Sinovac Biotech Ltd.