AsianScientist (Apr. 1, 2013) – Takeda Pharmaceutical Company Limited announced on Wednesday that it has submitted New Drug Applications for cell culture-based H5N1 and prototype pandemic influenza vaccines to the Ministry of Health, Labor and Welfare in Japan, using its Hikari Plant as the manufacturing facility.
In December 2010, Takeda and the Illinois, US-based Baxter International Inc. entered into a Development, License and Technology Transfer Agreement in which Baxter licensed exclusive rights to its proprietary cell culture-based pandemic influenza vaccines technology for the Japanese market to Takeda.
Based on the agreement, Takeda has been conducting development activities jointly with Baxter and constructing the manufacturing facility for cell culture-based influenza vaccines at its state-of-the-art Hikari Plant influenza facility, in order to establish the supply source in Japan.
Takeda and Baxter jointly submitted NDAs in September 2012 to the MHLW for cell culture-based pandemic influenza vaccines with Baxter’s plant in Europe as the manufacturing site. The NDAs submitted this round cover vaccine product produced at Takeda’s Hikari Plant and for which Takeda has conducted testing to demonstrate equivalence to vaccine manufactured at Baxter’s facility.
The Japanese government had previously offered a subsidy to support the investment associated with the development and production of pandemic influenza vaccine in Japan, and it selected Takeda as one of recipients of that subsidy. Takeda is aiming to obtain the approval of the NDAs within fiscal 2013 through close coordination with the regulatory authorities.
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