Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, and SK bioscience, a vaccine business subsidiary of SK
Group, today announced a development and supply agreement for the
antigen component of NVX-CoV2373, Novavax’ COVID-19 vaccine
candidate, for supply to global markets including the COVAX
Facility. In addition, the companies have signed a letter of intent
with the Republic of Korea’s Ministry of Health and Welfare to work
toward broad and equitable access to NVX-CoV2373 for the global
market as well as to make the vaccine available in South Korea.
Under the terms of the agreement, SK bioscience
will manufacture the vaccine antigen component for use in the final
drug product globally during the pandemic period.
NVX-CoV2373 was developed using Novavax'
recombinant nanoparticle technology to generate a stable, prefusion
antigen derived from the coronavirus spike (S) protein. It contains
Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the
immune response and stimulate high levels of neutralizing
antibodies. Phase 1 data from the Company’s Phase 1/2 randomized,
observer-blinded, placebo-controlled trial shows that NVX-CoV2373
was generally well-tolerated and elicited robust antibody responses
numerically superior to that seen in human convalescent sera.
SK bioscience, using its cell culture and
recombinant protein capability, will initiate the production of the
NVX-CoV2373 antigen at its vaccine facility in Andong L-house,
South Korea beginning in August 2020.
This contract development and manufacturing
organization agreement leverages the capacity reservation agreement
between SK bioscience and the Coalition for Epidemic Preparedness
Innovations (CEPI). Novavax' NVX-CoV2373 will be manufactured using
a part of the reserved capacity at SK Bioscience’s “L-House”
facility.
This agreement further boosts the potential
global supply of the NVX-CoV2373 vaccine and is an important
component of Novavax’ collaboration with CEPI. Through that
partnership with CEPI, Novavax has committed to develop and
manufacture significant amounts of NVX-CoV2373, including vaccine
derived from antigen coming from SK bioscience, if proved safe and
effective, to be procured and distributed by the COVAX Facility
through a globally fair allocation framework.
"We are proud to partner with SK bioscience to
fulfill our commitment to ensure global supply of NVX-CoV2373 in
alignment with our partnership with CEPI,” said Stanley C. Erck,
President and CEO of Novavax. “SK bioscience shares our sense of
urgency to ensure broad and equitable access for our COVID-19
vaccine candidate around the world.”
Jaeyong Ahn, CEO of SK bioscience said, "SK's
accumulated vaccine R&D and production capability has been
spotlighted by the world's most advanced global pharmaceutical
companies as well as the global initiatives for the COVID-19
vaccine manufacturing and supply such as CEPI." He added, "We will
cooperate with the government supporting its two-track strategy,
developing vaccine in Korea and securing COVID-19 vaccine from a
global manufacturer in a short period of time."
For further information, including media-ready
images, b-roll, downloadable resources and more, click here.
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. 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.
About SK bioscience
SK bioscience is an innovative South Korean
biopharmaceutical company specialized in the vaccine area. SK
bioscience developed the cell-culture based influenza vaccine named
SKYCellFluTM prequalified by WHO in 2019, SKYZosterTM, the world’s
second vaccine for shingles, and SKYVaricellaTM, the world’s second
WHO prequalified varicella vaccine for chicken pox. By leveraging
the company’s strengths on cutting-edge vaccine technologies, SK
bioscience has been expanding its R&D portfolio including
pneumococcal conjugate vaccine, human papillomavirus vaccine,
typhoid conjugate vaccine and non-replicating rotavirus vaccine
through in-house development or external partnership with public
and private institutions around the globe pursuing global health.
For the COVID-19 vaccine response, SK bioscience is undergoing
development for its vaccine candidate against SARS-CoV-2 with
support from the Bill and Melinda Gates Foundation.
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 manufacturing of
vaccine antigen dose amounts and timing, 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, as filed
with the Securities and Exchange Commission (SEC) and updated by
any Quarterly Report on Form 10-Q, particularly the risks inherent
to developing novel vaccines. We caution investors not to place
considerable reliance on the 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 Speak
amy@speaklifescence.com617-420-2461
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Apr 2023 to Apr 2024