Valneva SE, 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.