Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine
08 January 2021 - 10:14AM
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced that it has executed an Advance Purchase
Agreement with the Commonwealth of Australia for 51 million doses
of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. This follows
an agreement in principle that was announced in November 2020.
NVX-CoV2373 is a recombinant protein vaccine adjuvanted with
Novavax’ proprietary Matrix-M™ to enhance the immune response.
Novavax is currently conducting late-stage
clinical studies to demonstrate the efficacy, safety and
immunogenicity of NVX-CoV2373 for the prevention of COVID-19. This
includes two large pivotal Phase 3 clinical trials in the United
States/Mexico (the PREVENT-19 trial) and in the United Kingdom, as
well as a Phase 2b trial in South Africa.
“The continued increase in significant COVID-19
transmission in virtually all parts of the world underscores the
need for multiple safe, efficacious vaccines in enormous quantities
to stop the pandemic,” said Stanley C. Erck, Novavax President and
Chief Executive Officer. “We appreciate the confidence of the
Australian government and the opportunity to play a role in
ensuring that its citizens will have access to a protein-based
vaccine that can be distributed using existing distribution
channels, should it receive regulatory approval.”
Novavax will work with Australia’s regulatory
agency, the Therapeutics Goods Administration (TGA), to obtain
product approvals upon demonstrating efficacy in clinical studies.
The company aims to deliver initial doses by mid-2021. As part of
the agreement, Australia will have the option to purchase up to an
additional 10 million doses.
Additional terms of the agreement were not
disclosed.
About NVX-CoV2373NVX-CoV2373 is
a protein-based 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. It is adjuvanted with Novavax’ patented saponin-based
Matrix-M™ to enhance the immune response and stimulate high levels
of neutralizing antibodies. NVX-CoV2373 contains purified protein
antigen and can neither replicate, nor can it cause COVID-19. In
preclinical studies, NVX-CoV2373 induced antibodies that block
binding of spike protein to cellular receptors and provided
protection from infection and disease. NVX-CoV2373 was generally
well-tolerated and elicited robust antibody response numerically
superior to that seen in human convalescent sera in Phase 1/2
clinical testing. NVX-CoV2373 is currently being evaluated in two
pivotal Phase 3 trials: a trial in the U.K that completed
enrollment in November and the PREVENT-19 trial in the U.S. and
Mexico that began in December. It is also being tested in two
ongoing Phase 2 studies that began in August: a Phase 2b trial in
South Africa, and a Phase 1/2 continuation in the U.S. and
Australia.
About Matrix-M™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.
About NovavaxNovavax,
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. The Company’s proprietary recombinant
technology platform combines the power and speed of genetic
engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. Novavax is
conducting late-stage clinical trials for NVX-CoV2373, its vaccine
candidate against SARS-CoV-2, the virus that causes COVID-19.
NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all
primary objectives in its pivotal Phase 3 clinical trial in older
adults and will be advanced for regulatory submission. Both vaccine
candidates incorporate Novavax’ proprietary saponin-based Matrix-M™
adjuvant to enhance the immune response and stimulate high levels
of neutralizing antibodies.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
Novavax Forward Looking Statements
Statements herein relating to the future of
Novavax and the ongoing development of its vaccine and adjuvant
products are forward-looking statements. Novavax cautions that
these forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include those identified under the
heading “Risk Factors” in the Novavax Annual Report on Form 10-K
for the year ended December 31, 2019, and Quarterly Report on Form
10-Q for the period ended September 30, 2020, as filed with the
Securities and Exchange Commission (SEC). We caution investors not
to place considerable reliance on forward-looking statements
contained in this press release. You are encouraged to read our
filings with the SEC, available at sec.gov, 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. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
Contacts:
Investors
Erika Trahan
ir@novavax.com
240-268-2022
Media
Edna Kaplan
media@novavax.com
617-974-8659
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