Novavax and Commonwealth of Australia Announce Agreement in Principle for Acquisition of Novavax COVID-19 Vaccine
05 November 2020 - 01:51AM
Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced the signing of a non-binding Heads of
Terms document with the Australian Government to supply 40 million
doses of the Company’s COVID-19 vaccine candidate, NVX-CoV2373, for
the Australian community.
“This arrangement with the Australian Government
reflects the importance of the ongoing clinical development of
NVX-CoV2373, and will ensure that the citizens of Australia will
have access to its supply,” said Stanley C. Erck, President and
Chief Executive Officer of Novavax. “We are pleased with the
progress of our ongoing Phase 3 clinical trial in the UK, and are
pressing forward to deliver efficacy data for NVX-CoV2373, with
interim data in this event-driven trial expected as soon as early
first quarter 2021.”
The Heads of Terms provides for the delivery of
NVX-CoV2373 to Australia starting as early as the first half of
2021, subject to the successful completion of Phase 3 clinical
development and approval of the vaccine by Australia’s Therapeutic
Goods Administration (TGA). The vaccine regimen is expected to
require two doses per individual, administered 21 days apart.
To date, Novavax has established various
agreements for the supply of NVX-CoV2373 directly to the United
States and the United Kingdom, Canada and now Australia, and
through partnerships, supply to Japan, South Korea and India.
Australia’s clinical
trial contribution
Australia has played a pivotal role in the
clinical development program for NVX-CoV2373. Australian clinical
researchers led the global Phase 1 clinical trial in August. This
trial involved 131 Australians across two trial sites (Melbourne
and Brisbane). In addition, approximately 690 Australians have
participated in the Phase 2 arm of the clinical trial, which has
been conducted across up to 40 sites in Australia and the U.S.
The planned global Phase 3 clinical programs
evaluating NVX-CoV2373 will assess immunity, safety and COVID-19
disease prevention. The trials seek to recruit members of the
community most vulnerable to COVID-19 – the elderly, those with
underlying medical conditions as well as diverse racial and ethnic
representation.
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’
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.
NVX-CoV2373 contains purified protein antigen and cannot replicate,
nor can it cause COVID-19. In preclinical trials, NVX-CoV2373
demonstrated induction of antibodies that block binding of spike
protein to receptors targeted by the virus, a critical aspect for
effective vaccine protection. In the Phase 1 portion of its 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. NVX-CoV2373 is also being
evaluated in a Phase 3 trial in the UK and 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. Novavax has
secured $2 billion in funding for its global coronavirus vaccine
program, including up to $388 million in funding from the Coalition
for Epidemic Preparedness Innovations (CEPI).
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 Manufacturing
Novavax is progressing large-scale manufacturing
of NVX-CoV2373 across multiple locations around the world. Delivery
of initial doses of the vaccine is expected as early as the end of
this year, with the goal to expand the production to enable
delivery of over 2 billion doses annually, once all production is
online.
About Novavax
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 currently conducting multiple clinical trials for
NVX-CoV2373, its vaccine candidate against the virus that causes
COVID-19, including a pivotal Phase 3 clinical trial in the United
Kingdom to evaluate the efficacy, safety and immunogenicity in
individuals aged 18-84 years of age. NanoFlu™, its
quadrivalent influenza nanoparticle vaccine, met all primary
objectives in its pivotal Phase 3 clinical trial in older adults.
Both candidate vaccines incorporate Novavax’ proprietary
saponin-based Matrix-M™ adjuvant 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.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 June 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.
Additional Contacts:
Novavax Investors: Erika
Trahan ir@novavax.com + 1 240-268-2022
International
Media:Edna
Kaplankaplan@kogspr.com (for Novavax outside Australia)+1
617-974-8659
In Australia:Anne-Marie Sparrow
Anne-marie@cube.com.au+61 417 421
560Cameron@cube.com.au+61 424 785 063
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