SYS-CON MEDIA Authors: Carmen Gonzalez, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

News Feed Item

Sanofi Pasteur Launches Next Generation Japanese Encephalitis Vaccine in Thailand

BANGKOK, December 17, 2012 /PRNewswire/ --

- New Japanese encephalitis vaccine indicated for children and adults -

- About 3 billion people living in Asia Pacific are at risk of Japanese encephalitis -  

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its next generation vaccine against Japanese encephalitis (JE) is now available in Thailand. The innovative JE vaccine requires a single dose for immunization against JE in adults. In children, a booster dose is recommended 12 to 24 months after the primary injection to ensure long-term protection.

About 3 billion people in the Asia Pacific Region are at risk of JE[1] for which there is no specific treatment[2]. JE is most common in children under 15 years of age. It is the leading cause of childhood viral neurological infection and disability in Asia. 20-30% of JE affected people die. 50% of survivors are left with long-term sequelae[3]. In Thailand JE vaccination was introduced in the 1990's along with vector control and educational programs. As a result, the incidence of JE was greatly reduced. Yet, the JE virus remains the cause of 15% of viral encephalitis in Thailand[4].

"There is no specific treatment for Japanese encephalitis and vaccination is the most effective way to be protected," said Kulkanya Chokephaibulkit, Professor of Pediatric Infectious Diseases at Siriraj Medical School. "This new Japanese encephalitis vaccine has shown to provide seroprotection to 96% of the children just 1 month after one dose and long term protection after a booster[5]. It should stimulate greater adoption of vaccination against Japanese encephalitis in Thailand in order to more efficiently protect children and adults against this devastating disease."

The Thai health authorities granted marketing authorization to the new JE Vaccine vaccine based on the review of clinical studies involving over 4,000 children and adults which demonstrated the safety of the vaccine and its ability to generate a protective immune response with one dose.

"This is an innovative vaccine that confers high-level protection against Japanese encephalitis after one dose. It can be easily integrated in the pediatric immunization schedule," said Emin Turan, General Manager Sanofi Pasteur in Thailand. "We believe the new Japanese encephalitis vaccine will help reduce the burden of this devastating disease in children and contribute to improve public health in Thailand."

About Sanofi Pasteur new JE vaccine

Sanofi Pasteur JE vaccine is a live-attenuated vaccine indicated for active immunization of people 12 months and older. The clinical data supporting the use of Sanofi Pasteur JE vaccine in children and in adults have been generated in multi-center studies conducted in the United-States, Australia, Thailand, and the Philippines with more than 2,400 adults and 2,200 children receiving Sanofi Pasteur JE vaccine. The safety and immunogenicity of the vaccine were compared to a licensed JE vaccine and placebo in adults and to a control vaccine in children. A pivotal Phase III study in adults showed that a single dose of Sanofi Pasteur JE vaccine is as immunogenic as three doses of the control vaccine. A single administration of Sanofi Pasteur JE vaccine elicited a protective level of neutralizing antibodies in approximately 93% and 99% of adults 14 days and 28 days after vaccine administration, respectively[5]. Over 84% of adults were still seroprotected 5 years after vaccination[6]. A Phase III study in children showed that approximately 95% of JE virus naive subjects were seroprotected 28 days after a single dose of Sanofi Pasteur JE vaccine[7]. The vaccine was well tolerated and there was no indication during the clinical development program of any safety concerns. The frequency of local and systemic reactions was comparable to those reported after administration of a placebo or a control vaccine.

About Japanese encephalitis

JE is caused by a virus transmitted by mosquitoes. The disease is neuro invasive with inflammation of the brain and its membranes (meninges). Most JE virus infections are mild (fever and headache) or without apparent symptoms, but up to 1 to 200 infections results in severe disease characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. The case fatality rate is 30-35% among those with disease symptoms with over 15,000 deaths per year[8]; 50% of those who survive suffer from lasting damage to the central nervous system. In areas where the JE virus is common, encephalitis occurs mainly in young children[9].

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: http://www.sanofipasteur.com or http://www.sanofipasteur.us

1. Erlanger TE, Weiss S, Keiser J, et al. Past, present, and future of Japanese encephalitis. Emerg Infect Dis. 2009; 15:1-7.

2. Japanese encephalitis. WHO Initiative for Vaccine Research

http://www.who.int/vaccine_research/diseases/vector/en/index1.html

3. Hanna JN, Ritchie SA, Phillips DA, et al. Japanese encephalitis in north Queensland, Australia, 1998. Medical Journal of Australia 1999; 170:533-6.

4. Australian Social Trends September 2010 Australian bureau of statistics catalogue no. 4102.0

5. Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Sabchareon A, Pancharoen C, Bouckenooghe A, et al. Safety and Immunogenicity of a Single Administration of Live-attenuated Japanese Encephalitis Vaccine in Previously Primed 2- to 5-year-olds and Naive 12- to 24-month-olds: Multicenter Randomized Controlled Trial. Pediatr Infect Dis J 2010 Dec;29(12):1111-7

6. Nasveld PE, Ebringer A, Elmes N, et al. Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: Randomized, double-blind, 5-year phase II study in healthy adults. Hum Vaccin 2010; 6:1038-46.

7. Feroldi E, Pancharoen C, Kosalaraksa P, et al. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: Randomized, controlled phase 3 immunogenicity and safety trial. Human Vaccines & Immunotherapeutics 2012; 8:929-37.

8. Campbell GL, Hills SL, Fischer M, et al. Estimated global incidence of Japanese encephalitis: a systematic review. Bull World Health Organ. 2011; 89:766-74E

9. United Nations The United Nations urbanization prospects: the 2005 revision. POP/DB/WUP/Rev.2005/1/F1. New York: United Nations; 2005

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contacts:

Global Media Relations            
Pascal Barollier            
T. +33-4-37-37-50-38    
[email protected]
http://www.sanofipasteur.com            

Thailand Media Relations    
Kanyaka Kovitvanij
T. +66-2-264-8989
[email protected]  
http://www.sanofipasteurthailand.com

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
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...
What do a firewall and a fortress have in common? They are no longer strong enough to protect the valuables housed inside. Like the walls of an old fortress, the cracks in the firewall are allowing the bad guys to slip in - unannounced and unnoticed. By the time these thieves get in, the damage is already done and the network is already compromised. Intellectual property is easily slipped out the back door leaving no trace of forced entry. If we want to reign in on these cybercriminals, it's hig...
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.