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UK to buy 60 million doses of NVX-CoV2373
Novavax partners with FUJIFILM Diosynth Biotechnologies to manufacture NVX-CoV2373 antigenic in the UK
Novavax and the UK government will collaborate on the UK Phase 3 clinical trial in the third quarter of this year
Novavax intends to do more functions for global markets
GAITHERSBURG, Maryland, August 14, 2020 (GLOBE NEWSWIRE) – Novavax, Inc. (Nasdaq: NVAX), a complex biotechnology company that will introduce next-generation vaccines for serious infectious diseases, today announced the signing of a Terms Agreement (Sheet Term) with the UK government for the acquisition of 60 million doses of NVX-CoV2373, Novavax’s COVID-19 vaccine, and a Phase 3 clinical trial to assess the effectiveness of the vaccine in the UK population. Novavax will also expand its collaboration with FUJIFILM Diosynth Biotechnologies, which will manufacture the NVX-CoV2373 antigenic component of its BillinghamArray Stockton-on-Tees in the United Kingdom, in addition to its s in North Carolina and Texas in the United States. The UK of FUJIFILM Diosynth Biotechnologies is expected to produce up to 180 million consistent doses per year, further strengthening the global supply of NVX-CoV2373 in other markets.
“We are revered as a spouse with the UK government to provide a vaccine that can provide significant coverage in the fight against the global fitness crisis,” said Stanley C. Erck, President and CEO of Novavax. “Our Phase 3 clinical trial in the UK will be an essential detail when comparing the efficacy of NVX-CoV2373, which, in a phase 1 trial, has already shown that it is well tolerated and would trigger physically potent antibody responses. We are also excited to expand our collaboration with FUJIFILM Diosynth Biotechnologies to manufacture our antigen at its UK plant.
“It is encouraging that Novavax’s recent clinical knowledge shows that his vaccine triggers a greater immune reaction than that of patients who have recovered from the disease,” said Kate Bingham, chair of the UK Government’s Vaccine Working Group. “We, Novavax, have a next-generation vaccine that may be the first in its elegance to protein-based vaccine options. We are pleased to join them and global organizations like CEPI to continue our mutual commitments to ensure global access to the vaccine.
The Phase 3 clinical trial will be a randomized, double-blind, placebo-controlled efficacy study in approximately 9,000 adults 18-85 years of age in the UK. The trial is expected to begin in the third quarter of this year, with the UK government supporting and providing infrastructure to Novavax in the execution of the trial. The trial will assess the ability of NVX-CoV2373 to protect against symptomatic COVID-19 disease as well as evaluate antibody and T-cell responses.
Under the terms of the agreement, Novavax will supply 60 million doses of NVX-CoV2373 to the UK from the first quarter of 2021. A surplus of antigen manufactured by FUJIFILM Diosynth Biotechnologies in Billingham, Stockton-on-Tees may be available for Novavax to sell in other markets outside the UK.
“To replace the pandemic course, FUJIFILM Diosynth Biotechnologies is greatly pleased to expand its partnership with Novavax to manufacture its COVID-19 vaccine candidate on our UK site,” said Paul Found, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies, UK site. “We are honored with the British government and Novavax for the non-unusual purpose of providing a safe and effective vaccine to the British people.”
About NVX-CoV2373
NVX-CoV2373 is a candidate vaccine designed from the sarS-CoV-2 genetic series, the virus guilty of COVID-19 disease. NVX-CoV2373 was created using Novavax recombinant nanoparticle generation to generate an antigen derived from the coronavirus peak protein (S) and comprises the Matrix-M adjuvant ™ patented novavax saponin-based for immune reaction and stimulate maximum levels of neutralizing antibodies. In preclinical trials, NVX-CoV2373 demonstrated the presence of antibodies that block the link of complex protein to receptors directed through the virus, an essential facet for effective vaccine protection. In his knowledge of Phase 1 of the Phase 1/2 clinical trial, NVX-CoV2373 was sometimes well tolerated and provoked numerically potent physically potent antibody reactions to those observed in convalescent human serums. Phase 2 clinical trials will begin in August. Novavax has secured a $2 billion investment for its global coronavirus vaccine program, adding up to $388 million in investment from the Coalition for Innovations in Epidemic Preparedness (CEPI).
About Matrix-M ™
The Matrix-M ™ patented saponin-based adjuvant from Novavax demonstrated a strong and well-tolerated effect by stimulating antigen presenting cells to the injection site and the presentation of antigen in local lymph nodes, stimulating immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a complex biogeneration company that promotes global fitness through the discovery, progression and commercialization of state-of-the-art vaccines to prevent you from serious infectious diseases. Novavax is in clinical trials with NVX-CoV2373, its vaccine candidate for SARS-CoV-2, the virus guiltn from COVID-19. NVX-CoV2373 was sometimes well tolerated and provoked numerically amazing physically powerful antibody reactions than those observed in convalescent human serums in their knowledge of Phase 1 of the Phase 1/2 clinical trial. NanoFlu ™, its tetravalent influenza vaccine, has achieved all the main objectives of its key phase 3 clinical trial in the elderly. Both candidate vaccines incorporate Novavax’s patented saponin-based Matrix-M ™ adjuvant for immune reaction and boost maximum levels of neutralizing antibodies. Novavax is one of the leading innovators of recombinant vaccines; its patented recombinant generation platform combines the strength and speed of genetic engineering to successfully produce premium immunogenic nanoparticles to meet urgent global fitness needs.
For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
Novavax’s forward-looking statements
The statements in this document regarding Novavax’s long-term long-term and the continued progress of its vaccines and adjuvants products are forward-looking statements. Novavax cautions that such forward-looking statements are subject to danger and uncertainty, which may cause the actual effects to differ materially from those expressed or implied in such statements. These dangers and uncertainties come with those known in “Risk Factors” in novavax’s Annual Report on Form 10-K for the year ended December 31, 2019 and the Quarterly Report on Form 8-K for the era ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We warn investors not to place significant confidence in the forward-looking statements contained in this press release. We inspire you to read our presentations to the SEC, which are in sec.gov, for a discussion on these and other dangers and uncertainties. The forward-looking statements contained in this press release refer only to the date of this document and we assume no legal responsibility to update or revise any of the statements. Our business is subject to significant hazards and uncertainties, in addition to those mentioned above. Investors, potential investors and others deserve to take these dangers and uncertainties into account.
Contacts:
Novavax
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