From the Wires
Sanofi Pasteur Files for Approval in Thailand and Australia of IMOJEV(TM), Single-dose Japanese Encephalitis Vaccine
- Novel Vaccine IMOJEV(TM) for the Prevention of Japanese Encephalitis in Children and Adults Living in Asia
By: PR Newswire
Jul. 7, 2009 02:00 AM
Japanese encephalitis is a viral infection that affects 30,000
to 50,000 people each year in
"The goal of sanofi pasteur is to provide an innovative
Japanese encephalitis vaccine to people who most need it in order to improve
public health in countries where the disease is endemic," said
"Japanese encephalitis control through immunization is
feasible and it reduces the burden of disease," said
The marketing authorization files are under review by the
Therapeutic Goods Administration in
The clinical data supporting the use of IMOJEV(TM) in children
and in adults have been generated in multi-center studies conducted in the
The safety and immunogenicity of IMOJEV(TM) was compared to a licensed Japanese encephalitis vaccine (JE-VAX(R)) and placebo in adults and to a control vaccine in children. A pivotal Phase III study in adults showed that a single dose of IMOJEV(TM) is as immunogenic as three doses of JE-VAX(R). A single administration of IMOJEV(TM) elicits a protective level of neutralizing antibodies in 93.6% and 99% of subjects 14 days and one month after vaccine administration, respectively. A Phase III study in children showed that 95% of JE virus naive subjects are seroprotected one month after a single dose of IMOJEV(TM). The vaccine is 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 in adult as well as in pediatric populations.
About Japanese encephalitis
Japanese encephalitis is a disease caused by a flavivirus that affects the membranes around the brain. Most JE virus infections are mild (fever and headache) or without apparent symptoms, but up to 1 in 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; 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 (1).
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to improve the
lives of everyone. Sanofi-aventis is listed in
Sanofi Pasteur, the vaccines division of sanofi-aventis Group,
provided more than 1.6 billion doses of vaccine in 2008, 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
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 financial projections and estimates and their
underlying assumptions, statements regarding plans, objectives, intentions
and expectations with respect to future events, operations, products and
services,and statements regarding future performance. Forward-looking
statements are generally identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans" and similar expressions. Although
sanofiaventis' 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-aventis, 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 those discussed or identified in the public filings
with the SEC and the AMF made by sanofi-aventis, including those listed under
"Risk Factors" and "Cautionary Statement Regarding Forward-Looking
Statements" in sanofi aventis' annual report on Form 20-F for the year ended
1. United Nations The United Nations urbanization prospects:
the 2005 revision. POP/DB/WUP/Rev.2005/1/F1.
2. Japanese encephalitis. WHO Initiative for Vaccine Research
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