Valneva Announces Approval of its Japanese Encephalitis Vaccine through Commercial Partner Adimmune in Taiwan
LYON, France, Jan. 11, 2016 (GLOBE NEWSWIRE) -- Valneva SE ("Valneva" or "the Company"), a leading pure play vaccine company, announced today that vaccine manufacturer Adimmune was granted marketing approval for Valneva's Japanese encephalitis (JE) vaccine by the Taiwanese Food & Drug Administration (TFDA). The product is expected to be marketed in Taiwan under the trade name JEVAL®.
This approval follows the agreement signed in 2014 between Valneva and Adimmune granting Adimmune the right to commercialize JEVAL® in Taiwan, including the right to locally fill and pack JEVAL® by using bulk product delivered by Valneva.
Thomas Lingelbach, President and CEO, and Franck Grimaud, Deputy CEO of Valneva commented, "The JEVAL® approval is an important step forward in our JE vaccine expansion strategy into endemic markets. Given Adimmune's leading position as a commercial vaccine manufacturer in Taiwan, we expect strong product supplies in this market, allowing us to leverage our existing manufacturing capacities and significantly contribute to our product profitability."
JE is recognized as a major public health issue in Asia and Adimmune has worked with the Taiwanese Center for Disease Control and Prevention for decades to ensure supply of its mouse-brain derived JE vaccine. Public tenders have historically reached a level of 600,000 doses per year. However, the Taiwanese Advisory Committee on Immunization Practices recently recommended the introduction of a cell culture-derived vaccine and the first tender for supply in 2017 is expected to be issued in the short-term. Valneva and Adimmune will carefully review any publicly issued tender in order to determine their ability to respond based on tender specifications.
In order to supply large quantities of JEVAL® for Taiwan's national immunization program at a competitive cost base, Adimmune intends to establish a local fill-and-finish of the vaccine within the next two years.
About Japanese Encephalitis
Japanese Encephalitis (JE) is a deadly infectious disease found mainly in Asia. 67,900 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 and other factors. JE is fatal in approximately 30% of those who show symptoms, and leaves half of survivors with permanent brain damage. The disease is endemic in Southeast Asia, a region with more than 3 billion inhabitants. In 2005, Japanese Encephalitis killed more than 1,200 children in only 1 month during an epidemic outbreak in Uttar Pradesh, India, and Nepal.
Adimmune's JE vaccine is indicated against Japanese encephalitis for individuals of 2 months of age and older who live in Taiwan. It received marketing approval for the vaccine, under the trade name JEVAL®. The vaccine is based on bulk product delivered by Valneva and is the only inactivated vaccine against Japanese encephalitis approved in Taiwan.
About Valneva SE
Valneva is a fully integrated vaccine company that specializes in the development, manufacture and commercialization of innovative vaccines with a mission to protect people from infectious diseases through preventative medicine.
The Company seeks financial returns through focused R&D investments in promising product candidates and growing financial contributions from commercial products, striving towards financial self-sustainability.
Valneva's portfolio includes two commercial vaccines for travelers: one for the prevention of Japanese Encephalitis (IXIARO®/JESPECT®) and the second (DUKORAL®) indicated for the prevention of Cholera and, in some countries, prevention of diarrhea caused by LT-ETEC. The Company has proprietary vaccines in development including candidates against Pseudomonas aeruginosa, Clostridium difficile and Lyme Borreliosis. A variety of partnerships with leading pharmaceutical companies complement the Company's value proposition and include vaccines being developed using Valneva's innovative and validated technology platforms (EB66® vaccine production cell line, IC31® adjuvant).
Valneva is listed on Euronext-Paris and the Vienna stock exchange and has operations in France, Austria, Scotland, Canada and Sweden with approximately 400 employees. More information is available at www.valneva.com.
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2016_01_11_JEV approval Tawain_EN http://hugin.info/143334/R/1977837/724210.pdf