- Novavax will license COVID-19 vaccine technology to Takeda for local production and commercialization in Japan
- Matrix-M adjuvant to be supplied from Novavax
- Government of Japan will provide funding to Takeda for technology transfer, establishment of infrastructure and scale-up of manufacturing
- Adds to Takeda's ongoing support of influenza pandemic preparedness in Japan
GAITHERSBURG, Md. and OSAKA, Japan, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, in Japan. NVX-CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' 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 year1.
"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.
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' 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 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 Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX-CoV2373.
Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
For more information, visit www.novavax.comand connect with us on Twitterand LinkedIn.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology.
Takeda's Commitment to Vaccines
Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, Zika and norovirus. Takeda's team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs. For more information, visit www.TakedaVaccines.com.
Novavax Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the rights and responsibilities of each of Novavax and Takeda in their partnership, plans related to manufacturing [, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.
Takeda Pharmaceutical Company Limited Forward-Looking Statements
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1. The projected capacity is an estimate only based on current assumptions from Novavax.