Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2...
February 26 2021 - 8:22AM
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, today
announced progress in its collaboration with Takeda Pharmaceutical
Company Limited, originally announced in August. The companies have
signed an exclusive license agreement for Takeda’s development,
manufacturing and commercialization of NVX-CoV2373, Novavax’
COVID-19 vaccine candidate, in Japan. Additionally, Takeda dosed
the first participants in a Phase 2 clinical trial to test the
immunogenicity and safety of Novavax’ vaccine candidate in the
Japanese population.
“This agreement progresses our collaboration
with Takeda as we rapidly work together to make our vaccine
candidate available in Japan,” said Stanley C. Erck, President and
Chief Executive Officer of Novavax. “It is vital that we extend the
reach and availability of vaccines like NVX-CoV2373 to stop the
COVID-19 pandemic, and Takeda is well positioned to make that
happen.”
Novavax and Takeda are collaborating on
manufacturing, clinical development and regulatory activities in
Japan. Novavax will transfer the technology for manufacturing of
the vaccine antigen and will supply its Matrix-M™ adjuvant to
Takeda. Takeda anticipates the capacity to manufacture over 250
million doses of the COVID-19 vaccine per year. Novavax will be
entitled to receive payments based on the achievement of certain
development and commercial milestones, as well as a portion of
proceeds from the vaccine.
In addition, Takeda has begun a
placebo-controlled, observer-blinded Phase 1/2 study in Japan to
evaluate the immunogenicity and safety of NVX-CoV2373 (known as
TAK-019 in Japan) in 200 healthy volunteers aged 20 years and
older. Participants will receive two doses of either vaccine or
placebo 21 days apart and will be followed for 12 months following
the second dose. Takeda is responsible for regulatory submission to
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and will
manufacture and commercialize NVX-CoV2373 (TAK-019) in Japan.
Novavax has previously reported positive interim
efficacy results of NVX-CoV2373, its recombinant protein-based
vaccine candidate, in an ongoing Phase 3 clinical trial taking
place in the United Kingdom.
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 89.3 percent overall efficacy 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 50-60
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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