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Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan
Agreement includes COVID-19 vaccine technology transfer to Takeda for local manufacturing and commercialization in JapanTakeda doses first participant in
About this update from Novavax, Inc.
[{"type":"text","content":"Agreement includes COVID-19 vaccine technology transfer to Takeda for local manufacturing and commercialization in JapanTakeda doses first participant in immunogenicity and safety study to support local regulatory application GAITHERSBURG, Md., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its collaboration with Takeda Pharmaceutical Company Limited, originally announced in August. The companies have signed an exclusive license agreement for Takeda’s development, manufacturing and commercialization of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, in Japan. Additionally, Takeda dosed the first participants in a Phase 2 clinical trial to test the immunogenicity and safety of Novavax’ vaccine candidate in the Japanese population. “This agreement progresses our collaboration with Takeda as we rapidly work together to make our vaccine candidate available in Japan,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “It is vital that we extend the reach and availability of vaccines like NVX-CoV2373 to stop the COVID-19 pandemic, and Takeda is well positioned to make that happen.” Novavax and Takeda are collaborating on manufacturing, clinical development and regulatory activities in Japan. Novavax will transfer the technology for manufacturing of the vaccine antigen and will supply its Matrix-M™ adjuvant to Takeda. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year. Novavax will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the vaccine. In addition, Takeda has begun a placebo-controlled, observer-blinded Phase 1/2 study in Japan to evaluate the immunogenicity and safety of NVX-CoV2373 (known as TAK-019 in Japan) in 200 healthy volunteers aged 20 years and older. Participants will receive two doses of either vaccine or placebo 21 days apart and will be followed for 12 months following the second dose. Takeda is responsible for regulatory submission to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and will manufacture and commercialize NVX-CoV2373 (TAK-019) in Japan. Novavax has previously reported positive interim e...