MONDAY, SEPTEMBER 26, 2016

Takeda Pharmaceutical submits new drug applications for pandemic influenza vaccines

Takeda Pharmaceutical Co., Ltd., announced on Wednesday that is has submitted new drug applications for cell culture-based pandemic influenza vaccines to Japan's Ministry of Health, Labor and Welfare.

Takeda and Baxter International, Inc., entered into a development, license and technology transfer agreement in Dec. 2010 in which Baxter agreed to license exclusive rights to its proprietary cell culture-based pandemic influenza vaccines technology for the Japanese market to Takeda, PipelineReview.com reports.

Takeda, based on the agreement, jointly conducted development activities with Baxter and constructed a state-of-the-art influenza facility at its Hikari Plant manufacturing facility to establish a supply source in Japan.

In Sept., Takeda and Baxter submitted NDAs jointly to the Ministry of Health, Labor and Welfare for cell culture-based pandemic influenza vaccines with Baxter's plant in Europe as the manufacturing site.

The current NDAs cover vaccine product produced at the Hikari Plant, as well as for testing to demonstrate equivalence to vaccine manufactured at Baxter's facility, according to PipelineReview.com.

A subsidy was previously offered by the Japanese government for the support of investment associated with the development and production of pandemic influenza vaccine in Japan. Takeda was selected as one of the recipients of that subsidy.