Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited, recently announced a partnership for the development, manufacturing and commercialization of  Novavax’ COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year.

“Takeda’s leading position in Japan, technical expertise, regulatory know-how and manufacturing capacity make the company an ideal partner to further expand the global availability of NVX‑CoV2373,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We look forward to collaborating with Takeda to rapidly develop, produce and commercialize the vaccine in Japan.”

Novavax and Takeda are partnering on manufacturing, clinical development and regulatory activities in Japan. Novavax will license and transfer manufacturing technologies to enable Takeda to manufacture the vaccine antigen and will supply the Matrix-M adjuvant to Takeda. Takeda will be responsible for regulatory submission to the MHLW and will produce and distribute NVX‑CoV2373 in Japan.

“Nothing is more important right now than protecting the world against COVID-19. We are excited to collaborate with Novavax to bring their promising vaccine candidate to Japan,” said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. “Today’s announcement builds upon our ongoing support of pandemic preparedness and demonstrates Takeda’s commitment to the health and well-being of the Japanese population.”

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.

About NVX-CoV2373

NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated an indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and the Department of Defense (DoD) is investing up to $60 million of funding to advance the clinical development of NVX‑CoV2373.