Click here to close now.

SYS-CON MEDIA Authors: Mike Kavis, Plutora Blog, Bart Copeland, Andreas Grabner, Liz McMillan

News Feed Item

Sinovac 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

BEIJING, April 28, 2014 /PRNewswire/ -- 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 doses annually).

In developing 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.

The WHO 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 WHO and Intravacc.

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 partner with WHO and Intravacc to develop and commercialize sIPV for future distribution both domestically and internationally. As part of selection process, we demonstrated our fully integrated vaccine capabilities, inclusive of conducting clinical trials, 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 a significant unmet medical need in China and other developing countries. By moving forward with the clinical development of sIPV with 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."

About Sabin-IPV

Sabin IPV is both safer to manufacture and 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.

About Polio

Polio (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.

Global Polio Eradication Initiative

The 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.

Improving 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.

OPV 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.

Polio Vaccination in China

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.

About Intravacc 

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.

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: [email protected]

Investors:

Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: [email protected]

Media:

Aaron Estrada
The Ruth Group
Tel: +1-646-536-7028
Email: [email protected]

SOURCE Sinovac Biotech Ltd.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along...
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @Things...
PubNub on Monday has announced that it is partnering with IBM to bring its sophisticated real-time data streaming and messaging capabilities to Bluemix, IBM’s cloud development platform. “Today’s app and connected devices require an always-on connection, but building a secure, scalable solution from the ground up is time consuming, resource intensive, and error-prone,” said Todd Greene, CEO of PubNub. “PubNub enables web, mobile and IoT developers building apps on IBM Bluemix to quickly add sc...
The cloud has transformed how we think about software quality. Instead of preventing failures, we must focus on automatic recovery from failure. In other words, resilience trumps traditional quality measures. Continuous delivery models further squeeze traditional notions of quality. Remember the venerable project management Iron Triangle? Among time, scope, and cost, you can only fix two or quality will suffer. Only in today's DevOps world, continuous testing, integration, and deployment upend...
Data-intensive companies that strive to gain insights from data using Big Data analytics tools can gain tremendous competitive advantage by deploying data-centric storage. Organizations generate large volumes of data, the vast majority of which is unstructured. As the volume and velocity of this unstructured data increases, the costs, risks and usability challenges associated with managing the unstructured data (regardless of file type, size or device) increases simultaneously, including end-to-...
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, includin...
The excitement around the possibilities enabled by Big Data is being tempered by the daunting task of feeding the analytics engines with high quality data on a continuous basis. As the once distinct fields of data integration and data management increasingly converge, cloud-based data solutions providers have emerged that can buffer your organization from the complexities of this continuous data cleansing and management so that you’re free to focus on the end goal: actionable insight.
Between the compelling mockups and specs produced by your analysts and designers, and the resulting application built by your developers, there is a gulf where projects fail, costs spiral out of control, and applications fall short of requirements. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, will present a new approach where business and development users collaborate – each using tools appropriate to their goals and expertise – to build mo...
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing...
The Internet of Things (IoT) is causing data centers to become radically decentralized and atomized within a new paradigm known as “fog computing.” To support IoT applications, such as connected cars and smart grids, data centers' core functions will be decentralized out to the network's edges and endpoints (aka “fogs”). As this trend takes hold, Big Data analytics platforms will focus on high-volume log analysis (aka “logs”) and rely heavily on cognitive-computing algorithms (aka “cogs”) to mak...
When it comes to the Internet of Things, hooking up will get you only so far. If you want customers to commit, you need to go beyond simply connecting products. You need to use the devices themselves to transform how you engage with every customer and how you manage the entire product lifecycle. In his session at @ThingsExpo, Sean Lorenz, Technical Product Manager for Xively at LogMeIn, will show how “product relationship management” can help you leverage your connected devices and the data th...
In the consumer IoT, everything is new, and the IT world of bits and bytes holds sway. But industrial and commercial realms encompass operational technology (OT) that has been around for 25 or 50 years. This grittier, pre-IP, more hands-on world has much to gain from Industrial IoT (IIoT) applications and principles. But adding sensors and wireless connectivity won’t work in environments that demand unwavering reliability and performance. In his session at @ThingsExpo, Ron Sege, CEO of Echelon...
With several hundred implementations of IoT-enabled solutions in the past 12 months alone, this session will focus on experience over the art of the possible. Many can only imagine the most advanced telematics platform ever deployed, supporting millions of customers, producing tens of thousands events or GBs per trip, and hundreds of TBs per month. With the ability to support a billion sensor events per second, over 30PB of warm data for analytics, and hundreds of PBs for an data analytics arc...
One of the biggest impacts of the Internet of Things is and will continue to be on data; specifically data volume, management and usage. Companies are scrambling to adapt to this new and unpredictable data reality with legacy infrastructure that cannot handle the speed and volume of data. In his session at @ThingsExpo, Don DeLoach, CEO and president of Infobright, will discuss how companies need to rethink their data infrastructure to participate in the IoT, including: Data storage: Understand...