The company was given licensed exclusive rights to Baxter’s proprietary cell culture-based pandemic influenza vaccines technology for the Japanese market as part of its 2010 December agreement with Baxter.
Under the agreement, Takeda and Baxter have been conducting development activities and constructing the manufacturing facility for cell culture-based influenza vaccines at Hikari plant jointly, to establish the supply source in Japan.
In September 2012 Takeda and Baxter jointly submitted NDAs to the MHLW for cell culture-based pandemic influenza vaccines with Baxter’s plant in Europe as the manufacturing site.
Takeda aims to obtain the approval of the NDAs within fiscal 2013 through close coordination with the regulatory authorities.