Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine fo...
February 15 2021 - 7:04PM
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, and SK
Bioscience, a vaccine business subsidiary of SK Group, today
announced an expanded collaboration and license agreement. In
addition to the already existing manufacturing arrangement, SK
Bioscience has obtained a license to manufacture and commercialize
NVX-CoV2373, Novavax’ COVID-19 vaccine, for sale to the Korean
government. SK Bioscience will add significant production capacity
under this new agreement. Novavax recently reported positive
interim efficacy results for the vaccine candidate in an ongoing
Phase 3 clinical trial in the United Kingdom and is also currently
conducting a Phase 3 trial in the U.S. and Mexico.
The agreement expands on an existing
manufacturing arrangement between Novavax and SK Bioscience and
calls for technology transfer related to the manufacturing of
Novavax’ protein antigen, supply of Matrix MTM adjuvant, and
support to SK Bioscience as needed to secure regulatory approval.
Concurrently, SK Bioscience has finalized an advance purchase
agreement with the Korean government to supply 40 million doses of
NVX-CoV2373 to the Republic of Korea beginning in 2021.
“SK Bioscience shares our sense of urgency to
deliver a safe and effective COVID-19 vaccine to protect the global
population, including the people of South Korea,” said Stanley C.
Erck, President and CEO, Novavax. “We are proud to expand our
partnership, which is another great milestone for both companies
toward increasing the supply of NVX-CoV2373.”
Technology transfer and production scaleup is
progressing well under the previously announced collaboration for
SK Bioscience to produce the protein antigen component of
NVX-CoV2373 for Novavax, which Novavax expects to deliver to global
markets, including the COVAX Facility.
“We are honored to continue to manufacture
Novavax’ innovative COVID-19 vaccine and provide a supply to the
Korean Government through this agreement,” said Jaeyong Ahn, CEO,
SK Bioscience. “We appreciate the collaboration of the Korean
Government and Novavax to make possible this momentous step
forward.”
NVX-CoV2373 was the first vaccine
to demonstrate clinical efficacy against the original
strain of COVID-19 and both of the rapidly emerging variants in
the United Kingdom and South Africa. NVX-CoV2373 can
neither cause COVID-19 disease nor can it replicate. It is shipped
in a ready-to-use liquid formulation. It is stable at 2°C to 8°C
(refrigerated), meaning that existing vaccine supply chain channels
can be used for its distribution.
About NVX-CoV2373
NVX-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 and 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. It 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 demonstrated efficacy of 89.3 percent
overall and 95.6 percent against the original strain in a post-hoc
analysis, 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 that
demonstrated up to 60 percent efficacy against newly emerging
escape variants, 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 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
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com
Solebury Trout
Jennifer Porcelli | 617-974-8659
jporcelli@soleburytrout.com
Media
Amy Speak | 617-420-2461
Laura Keenan | 410-419-5755
media@novavax.com
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