Full Press Release Details
Enters Technology Transfer Agreement with Intravacc to Develop and Commercialize Sabin Inactivated Polio Vaccine (sIPV)
Collaborating with World Health Organization and Intravacc to Develop sIPV in line with mission to secure a lasting polio-free
world, free of all paralytic polio disease
Enters Technology Transfer Agreement with Intravacc to Develop and Commercialize Sabin Inactivated Polio Vaccine (sIPV)
with World Health Organization and Intravacc to Develop sIPV in line with mission to secure a lasting polio-free world, free of
all paralytic polio disease
BEIJING, April 28, 2014-Sinovac
Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China that focuses on the research, development,
manufacturing and commercialization of vaccines, announced today that it has entered into a license agreement with Intravacc (Institute
for Translational Vaccinology) from The Netherlands to develop and commercialize the Sabin Inactivated Polio Vaccine (sIPV) for
distribution to China and other countries. According to the agreement, Sinovac has committed to commercializing the vaccine in
China, inclusive of conducting clinical trials, obtaining regulatory approval, and launching the sIPV vaccine. In addition,
Sinovac has committed to having the capacity to supply, or making arrangements for the supply of, sIPV to the public sector of
other countries in sufficient quantities to make a meaningful contribution to meeting global demand (e.g. at least 20 million
countries around the globe including China, oral polio vaccine (OPV) is widely utilized to eradicate polio. OPV is a live
attenuated formulation, which contains a weakened form of poliovirus. Although OPV is considered safe and effective, in extremely
rare instances, the live attenuated vaccine virus in OPV can cause paralysis, resulting in cases of vaccine-associated paralytic
polio (VAPP) or circulating vaccine-derived poliovirus (cVDPVs). Therefore, to eliminate the risk of such cases, OPV will be
phased out from routine immunization programs around the world. To enable countries to maintain immunity levels, inactivated
polio vaccines (IPV) will be introduced. Sabin IPV is both safer to manufacturer and more affordable as compared to the
currently available Salk IPV. The global demand for IPV is increasing as the Global Polio Eradication Initiative has called
for IPV to be introduced into 126 countries currently using OPV only by the end of 2015. According to Eradication and Endgame
Strategic Plan developed under the Global Polio Eradication Initiative, from 2014 to 2018, the use of OPV in routine immunization
will be gradually ceased.
called for Expressions of Interest (EOI) in 2010, 2011 and 2012 from private or public sector vaccine manufactures interested
incollaborating with the WHO and Intravacc to develop and supply sIPV under the Global Polio Eradication Initiative. Sinovac submitted
its EOI in 2012 and was selected as a technology transfer recipient after the qualification review and site inspection by the
National Health and Family Planning
Commission of China is developing a vaccination strategy to add at least one dose of IPV into its national Expanded Program of
Immunization (EPI). At present, no IPV is produced by manufacturers in China. Imported IPV became available in September
2009, but the supply is limited and the vaccine has to be paid for out-of-pocket by the recipient.
Mr. Weidong Yin, Chairman, President
and CEO of Sinovac, commented, "We are honored to partnerwith WHO and Intravacc to develop and commercialize sIPV for future
distribution both domestically and internationally. As part of selection process, we demonstrated our fullyintegrated vaccine
capabilities, inclusive ofconducting clinicaltrials, obtaining regulatory approval and operating GMP certified manufacturing facilities,
and exemplified our commercialization expertise based on our broad vaccine portfolio."
Mr. Yin continued, "Polio
represents significant unmet medical need in China and other developing countries. By moving forward with the clinical development
of sIPVwith the objective of producing this vaccine in China, Sinovac is helping keep China polio-free and achieve a lasting polio-free
world, free of all polio paralytic cases."
Ms. Gisella Frijlink, Chief Executive
Officer of Intravacc, stated, "We are pleased to enter into the collaboration with Sinovac, one of the leading Chinese vaccine
companies. This project will enable Sinovac to supply a safe and affordable sIPV vaccine to the Chinese population, as well as
to other countries. It also exemplifies the leading position of the Netherlands in the vaccine field and Intravacc's
important role in the global eradication of polio".
both safer to manufacturerand potentially more affordable as compared to the currently available Salk IPV. Intravacc has
developed a safer production process to manufacture IPV, using the attenuated strains from the Sabin virus as seed. In collaboration
with Intravacc, clinical lots of IPV produced from Sabin poliovirus seed-strains have been developed. Salk IPV is manufactured
using wild poliovirus seed-strains, and in such a case a biocontainment failure could lead to serious consequences in some areas
of the world in the post-eradication era (i.e. areas with high population density, inadequate sanitation infrastructure and
low population immunity levels). Therefore, the use of attenuated Sabin seed-strains for IPV has the advantage over wild polioviruses
and hence is safer for handling IPV production in developing country settings.
(Poliomyelitis) is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis.
The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting,
stiffness in the neck, and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among
those paralyzed, 5-10% die when their breathing muscles become immobilized.
Polio Eradication Initiative
Global Polio Eradication Initiative is a public-private partnership led by national governments and spearheaded by the WHO, Rotary
International, the US Centers for Disease Control and Prevention (CDC), and the United Nations Children's Fund (UNICEF).
Its goal is to eradicate polio worldwide.
immunization services globally is vital to ending polio and reducing child mortality. Strong immunization services are also essential
to ensuring the success of the phased withdrawal of the OPV and the introduction of the IPV, key steps toward eradication. The
Global Polio Eradication Initiative's Strategic Plan calls for IPV to be introduced into 126 countries by the end of 2015.
contains an attenuated (weakened) vaccine-virus, activating an immune response in the body. When a child is immunized with OPV,
the weakened vaccine-virus replicates in the intestine for a limited period, thereby developing immunity by building up antibodies.
During this time, the vaccine-virus is also excreted. In areas of inadequate sanitation, this excreted vaccine-virus can spread
in the immediate community (and this can offer protection to other children through passive' immunization), before
eventually dying out.
Vaccination in China
together with the entire Western Pacific Region, was officially certified polio-free in 2000, and the region has maintained its
certified status since then. National Health and Family Planning Commission China is developing a strategy to add at least
one dose of IPV into its national EPI programme, currently it continues to recommend the use of OPV in its national EPI programme.
In China, enough OPV is produced by domestic manufacturers to vaccinate all children born in the country every year. Based
on the batch release data available as of December 31, 2013, approximately 145 million doses of OPV and 8.3 million doses of IPV
were released in China in 2013. In 2011, China experienced an outbreak caused by imported wild poliovirus type 1 from Pakistan.
China successfully stopped the importation outbreak in only three months, thereby ensuring the Western Pacific Region could maintain
its certified polio-free status. The outbreak affected 10 young children and 11 adults, and resulted in two deaths. China
is located next to two of the three countries globally that remain polio-endemic, Pakistan and Afghanistan.
Intravacc (the Institute for Translational Vaccinology) is a research, development and contract manufacturing organization uniquely
active in the field of vaccines. It covers over 100 years of know-how in vaccinology as a governmental institute working under
the Dutch Ministry of Public Health, Welfare and Sports. With its mission to promote public health by developing vaccines, Intravacc
is committed to provide all necessary technology and expertise needed to develop a vaccine from a laboratory concept until phase
III clinical studies. The risks and cost of vaccine development can be substantially reduced with the use of Intravaccs technology.
This enables vaccine manufacturers to viably produce and distribute vaccines to combat major public health concerns. An example
is the conjugate vaccine against Haemophilus influenzae type b, which is now being marketed in Asia. To date, Intravacc has
a full pipeline of vaccine concepts against various bacterial, viral and non-infectious diseases. Several of these vaccine development
programs are taken forward in collaboration with big pharma as well as biotech companies.
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.
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