Novavax and UK Government Announce Collaboration and Purchase Agreement for Novavax’ COVID-19 Vaccine Candidate
August 14 2020 - 1:07AM
Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced it has signed a Heads of Terms (Term
Sheet) with the Government of the United Kingdom (UK) for the
purchase of 60 million doses of NVX-CoV2373, Novavax’ COVID-19
vaccine, and a Phase 3 clinical trial to assess the efficacy of the
vaccine in the UK population. Novavax will also expand its
collaboration with FUJIFILM Diosynth Biotechnologies, which will
manufacture the antigen component of NVX-CoV2373 from its
Billingham, Stockton-on-Tees site in the UK, in addition to its
sites in North Carolina and Texas in the United States. The
FUJIFILM Diosynth Biotechnologies site in the UK is expected to
produce up to 180 million doses annually, which further boosts
the global supply of NVX-CoV2373 for additional markets.
“We are honored to partner with the UK
government to deliver a vaccine that could provide vital protection
in the fight against the global health crisis,” said Stanley C.
Erck, President and Chief Executive Officer of Novavax. “Our Phase
3 clinical trial in the UK will be a critical component to assess
the efficacy of NVX-CoV2373, which in a Phase 1 trial has already
demonstrated to be generally well-tolerated and to elicit robust
antibody responses. We are also delighted to expand our
collaboration with FUJIFILM Diosynth Biotechnologies to manufacture
our antigen at its UK site.”
“It is encouraging that Novavax’ recent clinical
data shows their vaccine triggers an immune response greater than
that in patients who have recovered from the disease,” said Kate
Bingham, Chair of the UK Government’s Vaccines Taskforce. “We
believe that Novavax has a highly innovative vaccine that could be
the first in its class of protein-based vaccine options. We are
happy to partner with them and global organizations such as CEPI to
further 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 beginning as early
as the first quarter of 2021. Excess supply of antigen manufactured
at the FUJIFILM Diosynth Biotechnologies site in Billingham,
Stockton-on-Tees may be available for Novavax to sell to
additional markets outside the UK.
“To change the course of the pandemic, FUJIFILM
Diosynth Biotechnologies is excited to expand our partnership with
Novavax to manufacture their COVID-19 vaccine candidate at our UK
site,” said Paul Found, Chief Operating Officer, FUJIFILM Diosynth
Biotechnologies, UK site. “We are honored to support the UK
government and Novavax with the shared goal of delivering a safe
and effective vaccine to the British people.”
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. 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. Phase 2 clinical trials will begin in August.
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 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 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.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
8-K 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.
Contacts:
Novavax
InvestorsSilvia Taylor and Erika
Trahanir@novavax.com240-268-2022
MediaBrandzone/Speak Life ScienceAmy
Speakamy@speaklifescence.com617-420-2461
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