Valneva Announces FDA Approval of IXIARO® Shelf Life Extension to 36 Months; New US Military RFP Issued
08 Marzo 2020 - 7:00PM
Saint Herblain (France), March 8, 2020 –
Valneva SE (“Valneva” or “the Company”), today announced that the
Food and Drug Administration (FDA) has approved the extension of
the shelf life of its Japanese encephalitis vaccine IXIARO® from 24
months to 36 months.
Separately, the US Department of Defense (“DoD”)
has issued a Request for Proposal (“RFP”) for Japanese Encephalitis
Vaccine. This RFP covers a period of three years comprising one
year plus two years of options. Valneva will respond to this RFP
expeditiously and, if successful, expects to enter into a new
supply contract during the first half of 2020.
Franck Grimaud, Valneva’s Chief Business
Officer, commented, “We are pleased to receive this
valuable shelf life extension for IXIARO® in the US. We also look
forward to continuing to work closely with the DoD and to meeting
their requirements. The U.S. military has been using IXIARO® for
the past ten years and we look forward to continuing to help
protect US troops, their families, military retirees, and
government service personnel from this potentially deadly
disease.”
About IXIARO®/JESPECT®
Valneva’s Japanese encephalitis vaccine is
indicated for active immunization for the prevention of the disease
for people who travel to, or live in, endemic areas. It has
received marketing approval in the U.S., Europe, Canada, Hong Kong,
Singapore, and Israel under the trade name IXIARO® and in Australia
and New Zealand where it is marketed as JESPECT®. IXIARO® was
developed through a cooperative research and development agreement
with the Walter Reed Army Institute of Research. Valneva markets
and distributes IXIARO® directly to the U.S. military and U.S.
private market. It is the only vaccine available to the U.S.
military for Japanese Encephalitis. IXIARO® is approved for use in
individuals two months of age and older in the U.S. and EU member
states, Canada, Norway, Liechtenstein, Iceland, Singapore, Hong
Kong, and Israel. In all other licensed territories,
IXIARO®/JESPECT® is indicated for use in persons aged 18 years or
more.
About Japanese Encephalitis
Japanese encephalitis is a deadly infectious
disease found mainly in Asia. About 70,000 cases of JE are
estimated to occur in Asia each year, although the actual number of
cases is likely much higher due to underreporting in rural areas.
JE is fatal in approximately 30 percent of those who show symptoms,
and leaves half of survivors with permanent brain damage. The
disease is endemic in Southeast Asia, India and China, a region
with a population of more than three billion. In 2005, JE killed
more than 1,200 children in only one month during an epidemic
outbreak in Uttar Pradesh, India, and Nepal.
About Valneva SE
Valneva is a specialty vaccine company focused
on prevention against diseases with major unmet needs. Valneva’s
portfolio includes two commercial vaccines for travelers:
IXIARO®/JESPECT® indicated for the prevention of Japanese
encephalitis and DUKORAL® indicated for the prevention of cholera
and, in some countries, prevention of diarrhea caused by ETEC. The
Company has various vaccines in development including unique
vaccines against Lyme disease and chikungunya. Valneva has
operations in Austria, Sweden, the United Kingdom, France, Canada
and the US with approximately 500 employees. More information is
available at www.valneva.com
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineDirector of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
research, development and clinical trials for product candidates,
the ability to manufacture, market, commercialize and achieve
market acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing
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performance and estimates regarding anticipated operating losses,
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of Valneva are consistent with the forward-looking statements
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are subject to a number of known and unknown risks and
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of Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines, unexpected
clinical trial results, unexpected regulatory actions or delays,
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global and European credit crisis, and the ability to obtain or
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disclaim any intention or obligation to publicly update or revise
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information, future events, or otherwise.
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2020_03_08_VLA_IXIARO_FDA_Shelf_Life_Extension_New_RFP_PR_EN