Under the terms of the agreement, Valneva will supply IXIARO® doses to the Defense Logistics Agency of the U.S. Department of Defense, through 2019 and the beginning of 2020 with a value of $59 million guaranteed and potentially worth up to $70 million. A delivery schedule is being prepared and supply shipments will commence immediately.
Franck Grimaud, Chief Business Officer of Valneva commented, “We are pleased to continue our important collaboration with the U.S. government to fight this deadly disease. The U.S. military has been using IXIARO® since 2010 and we are excited to further support the expansion of its use and help protect military personnel and their families from Japanese encephalitis.”
IXIARO® is the only JE vaccine approved by the U.S. Food and Drug Administration (FDA). It has been 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. In October 2018, the Company announced that the FDA approved an accelerated IXIARO® vaccination schedule of two doses administered seven days apart, compared to the previous 28 day schedule. The accelerated schedule was approved for adult travelers aged 18-65 years in addition to the previously approved schedule.
Following this contract award, the Company will provide initial financial guidance on the outlook for 2019.
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®. 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 biotech company developing and commercializing vaccines for infectious 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 a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 450 employees. More information is available at www.valneva.com.