Valneva Announces FDA Approval of IXIARO® Shelf Life Extension to 36 Months; New US Military RFP Issued
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.”
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
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