Takeda Pharmaceutical Company Limited announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.
As part of a previously announced agreement with Novavax, Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in early calendar year 2022. Novavax is licensing and transferring manufacturing technologies to enable Takeda to manufacture the vaccine antigen and is supplying the Matrix-M adjuvant to Takeda for fill/finish together with the antigen. Takeda is responsible for the Japanese clinical trial and regulatory submission to the Pharmaceuticals and Medical Devices Agency (PMDA) and will distribute TAK-019 in Japan should it be approved by the MHLW.
Takeda’s efforts to transfer technology, establish production facilities and distribute Novavax’ vaccine candidate in Japan are supported by the MHLW under its supplementary budget for emergency maintenance associated with the vaccine production system.
The impact of this agreement on Takeda’s forecast for the fiscal year ending March 31, 2022 (FY2021) will depend on the exact timing of distribution. Takeda will update its FY2021 forecast at the appropriate timing, as necessary, also taking other factors into consideration.